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COVID-19 Study Assessing the Virologic Efficacy of REGN10933+REGN10987 Across Different Dose Regimens in Adult Outpatients With SARS-CoV-2 Infection

Sponsor
Regeneron Pharmaceuticals (Industry)
Overall Status
Completed
CT.gov ID
NCT04666441
Collaborator
(none)
1,149
Enrollment
57
Locations
8
Arms
9.2
Actual Duration (Months)
20.2
Patients Per Site
2.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The primary objective of the study is to assess the virologic efficacy of REGN10933+REGN10987 across different intravenous and subcutaneous doses compared to placebo.

The secondary objectives of the study are:

  • To evaluate additional indicators of virologic efficacy of REGN10933+REGN10987 compared to placebo

  • To evaluate the safety and tolerability of REGN10933+REGN10987 compared to placebo

  • To assess the concentrations of REGN10933 and REGN10987 in serum over time

  • To assess the immunogenicity of REGN10933 and REGN10987

Condition or Disease Intervention/Treatment Phase
  • Drug: REGN10933+REGN10987 combination therapy
  • Drug: Placebo
 Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
1149 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Phase 2 Study to Assess the Virologic Efficacy of REGN10933+REGN10987 Across Different Dose Regimens in Outpatients With SARS-CoV-2 Infection
Actual Study Start Date :
Dec 15, 2020
Actual Primary Completion Date :
Mar 4, 2021
Actual Study Completion Date :
Sep 21, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: IV Dose 1

Combination therapy intravenous (IV) single dose

Drug: REGN10933+REGN10987 combination therapy
Administered IV or SC single dose
Other Names:
  • REGN-COV2
  • REGEN-COV™
  • Ronapreve™
  • casirivimab
  • imdevimab

    		•
    Experimental: IV Dose 2

    Combination therapy IV single dose

    Drug: REGN10933+REGN10987 combination therapy
    Administered IV or SC single dose
    Other Names:
  • REGN-COV2
  • REGEN-COV™
  • Ronapreve™
  • casirivimab
  • imdevimab

    		•
    Experimental: IV Dose 3

    Combination therapy IV single dose

    Drug: REGN10933+REGN10987 combination therapy
    Administered IV or SC single dose
    Other Names:
  • REGN-COV2
  • REGEN-COV™
  • Ronapreve™
  • casirivimab
  • imdevimab

    		•
    Experimental: IV Dose 4

    Combination therapy IV single dose

    Drug: REGN10933+REGN10987 combination therapy
    Administered IV or SC single dose
    Other Names:
  • REGN-COV2
  • REGEN-COV™
  • Ronapreve™
  • casirivimab
  • imdevimab

    		•
    Experimental: Placebo IV Dose

    Matching placebo IV single dose

    Drug: Placebo
    Administered IV or SC single dose to match
    Experimental: SC Dose 1

    Combination therapy subcutaneous (SC) single dose

    Drug: REGN10933+REGN10987 combination therapy
    Administered IV or SC single dose
    Other Names:
  • REGN-COV2
  • REGEN-COV™
  • Ronapreve™
  • casirivimab
  • imdevimab

    		•
    Experimental: SC Dose 2

    Combination therapy SC single dose

    Drug: REGN10933+REGN10987 combination therapy
    Administered IV or SC single dose
    Other Names:
  • REGN-COV2
  • REGEN-COV™
  • Ronapreve™
  • casirivimab
  • imdevimab

    		•
    Experimental: Placebo SC Dose

    Matching placebo SC single dose

    Drug: Placebo
    Administered IV or SC single dose to match

    Outcome Measures

    Primary Outcome Measures

    1. Time-Weighted Average Daily Change From Day 1 in Viral Load in NP Swab Samples [Day 1 to Day 7]

      Time-weighted average daily change from Day 1 in viral load (log10 copies/mL), as measured by reverse transcription quantitative polymerase chain reaction (RT-qPCR) in nasopharyngeal (NP) swab samples.

    Secondary Outcome Measures

    1. Time-Weighted Average Daily Change From Day 1 in Viral Load [Day 1 to Day 5]

      Time-weighted average daily change from Day 1 in viral load (log10 copies/mL) as measured by reverse transcription quantitative polymerase chain reaction (RT-qPCR) in nasopharyngeal (NP) swab samples.

    2. Time-Weighted Average Daily Change From Day 1 in Viral Load in Participants With High Viral Load at Baseline [Day 1 to Day 7]

      Time-weighted average daily change from Day 1 in viral load (log10 copies/mL) as measured by reverse transcription quantitative polymerase chain reaction (RT-qPCR) in nasopharyngeal (NP) swab samples. in any participant with a viral load greater than 10,000 copies/mL at baseline.

    3. Time-Weighted Average Daily Change From Day 1 in Viral Load in Participants With High Viral Load at Baseline [Day 1 to Day 5]

      Time-weighted average daily change from Day 1 in viral load (log10 copies/mL) as measured by reverse transcription quantitative polymerase chain reaction (RT-qPCR) in nasopharyngeal (NP) swab samples. in any participant with a viral load greater than 10,000 copies/mL at baseline.

    4. Number of Participants With High Viral Load [Day 1, Day 3, Day 5, Day 7, Day 15, Day 22]

      Number of participants with viral load greater than 10,000 copies/mL, as measured by reverse transcription quantitative polymerase chain reaction (RT-qPCR) in nasopharyngeal (NP) swab samples.

    5. Number of Participants With Viral Loads Below the Limit of Detection [Day 1, Day 3, Day 5, Day 7, Day 15, Day 22]

      Number of participants with viral load less than 299 copies/mL, as measured by reverse transcription quantitative polymerase chain reaction (RT-qPCR) in nasopharyngeal (NP) swab samples.

    6. Number of Participants With Viral Loads Below the Lower Limit of Quantification [Day 1, Day 3, Day 5, Day 7, Day 15, Day 22]

      Number of participants with viral load less than 714 copies/mL, as measured by reverse transcription quantitative polymerase chain reaction (RT-qPCR) in nasopharyngeal (NP) swab samples.

    7. Change From Day 1 in Viral Load as Measured by RT-qPCR in NP Swab Samples [Day 3, Day 5, Day 7, Day 15, Day 22]

      Change from Day 1 in Viral Load (log10 copies/mL) as Measured by Quantitative reverse transcription polymerase chain reaction (RT-qPCR) in nasopharyngeal (NP) Swab Samples

    8. Number of Participants With Treatment-Emergent Serious Adverse Events (SAEs) [Through day 29]

    9. Number of Participants With Infusion-Related Reactions Grade 2 or Above [Through day 4]

    10. Number of Participants With Injection-Site Reactions Grade 3 or Above [Through day 4]

    11. Number of Participants With Hypersensitivity Reactions Grade 2 or Above [Through day 29]

    12. Concentration of REGN10933 in Serum [Pre-Dose, 15 minutes Post-Dose, 3 days Post-Dose, 5 days Post-Dose, 7 days Post-Dose, 120 days Post-Dose]

    13. Immunogenicity as Measured by Anti-drug Antibodies (ADAs) to REGN10933 [Through day 120]

    14. Immunogenicity as Measured by Neutralizing Anti-drug Antibody (NAb) to REGN10933 [Through day 120]

    15. Concentration of REGN10987 in Serum [Pre-Dose, 15 minutes Post-Dose, 3 days Post-Dose, 5 days Post-Dose, 7 days Post-Dose, 120 days Post-Dose]

    16. Immunogenicity as Measured by Anti-drug Antibodies (ADAs) to REGN10987 [Through day 120]

    17. Immunogenicity as Measured by Neutralizing Anti-drug Antibody (NAb) to REGN10987 [Through day 120]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Key Inclusion Criteria:

    • Has SARS-CoV-2-positive diagnostic test from a sample collected ≤72 hours prior to randomization, as defined by the protocol

    • Low-risk symptomatic patient: Has symptoms consistent with COVID-19 (as determined by the investigator) with onset ≤7 days before randomization, and meets all of the following 8 criteria:

    1. Age ≤50

    2. No obesity, with obesity defined as BMI ≥30 kg/m2

    3. Does not have cardiovascular disease or hypertension

    4. Does not have chronic lung disease or asthma

    5. Does not have type 1 or type 2 diabetes mellitus

    6. Does not have chronic kidney disease, with or without dialysis

    7. Does not have chronic liver disease

    8. Is not pregnant or

    • Asymptomatic patient: Has had no symptoms consistent with COVID-19 (as determined by the investigator) occurring at any time <2 months prior to randomization

    • Maintains O2 saturation ≥93% on room air

    Key Exclusion Criteria:

    • Was admitted to a hospital for COVID-19 prior to randomization, or is hospitalized (inpatient) for any reason at randomization

    • Has a known positive SARS-CoV-2 serologic test

    • Has a positive SARS-CoV-2 antigen or molecular diagnostic test from a sample collected

    72 hours prior to randomization

    • Is immunosuppressed, based on investigator's assessment

    • Has participated, or is participating, in a clinical research study evaluating COVID-19 convalescent plasma, mAbs against SARS-CoV-2, or intravenous immunoglobulin (IVIG) within 3 months or within 5 half-lives of the investigational product (whichever is longer) prior to the screening visit

    • Prior, current, or planned future use of any of the following treatments: COVID-19 convalescent plasma, mAbs against SARS-CoV-2, (eg, bamlanivimab), IVIG (any indication), systemic corticosteroids (any indication), or COVID-19 treatments (authorized, approved, or investigational)

    • Prior use (prior to randomization), current use (at randomization), or planned use (within time period given per CDC guidance but no sooner than 22 days of study drug administration) of any authorized or approved vaccine for COVID-19

    • Has known active infection with influenza or other non-SARS-CoV-2 respiratory pathogen, confirmed by a diagnostic test

    • Has participated, is participating, or plans to participate in a clinical research study evaluating any authorized, approved, or investigational vaccine for COVID-19

    NOTE: Other protocol defined inclusion/exclusion criteria apply

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Regeneron Study Site Mesa Arizona United States 85210
    2 Regeneron Study Site Tucson Arizona United States 85712
    3 Regeneron Study Site Canoga Park California United States 91303
    4 Regeneron Study Site Long Beach California United States 90806
    5 Regeneron Study Site Los Angeles California United States 90036
    6 Regeneron Study Site Rolling Hills Estates California United States 90274
    7 Regeneron Study Site San Francisco California United States 94127
    8 Regeneron Study Site Santa Monica California United States 90404
    9 Regeneron Study Site Stanford California United States 94305
    10 Regeneron Study Site Colorado Springs Colorado United States 80907
    11 Regeneron Study Site Washington District of Columbia United States 20037
    12 Regeneron Study Site DeLand Florida United States 32720
    13 Regeneron Study Site Fort Pierce Florida United States 34982
    14 Regeneron Study Site Hialeah Florida United States 33010
    15 Regeneron Study Site Hialeah Florida United States 33012
    16 Regeneron Study Site Maitland Florida United States 32751
    17 Regeneron Study Site Miami Florida United States 33126
    18 Regeneron Study Site Miami Florida United States 33184
    19 Regeneron Study Site Saint Petersburg Florida United States 33705
    20 Regeneron Study Site Tampa Florida United States 33606
    21 Regeneron Study Site West Palm Beach Florida United States 33407
    22 Regeneron Study Site Winter Haven Florida United States 33880
    23 Regeneron Study Site Winter Park Florida United States 32789
    24 Regeneron Study Site Atlanta Georgia United States 30322
    25 Regeneron Study Site Columbus Georgia United States 31904
    26 Regeneron Study Site Downers Grove Illinois United States 60515
    27 Regeneron Study Site Ames Iowa United States 50010-3014
    28 Regeneron Study Site Iowa City Iowa United States 52242
    29 Regeneron Study Site Lake Charles Louisiana United States 70601
    30 Regeneron Study Site Marrero Louisiana United States 70072
    31 Regeneron Study Site Shreveport Louisiana United States 71118
    32 Regeneron Study Site Baltimore Maryland United States 21201
    33 Regeneron Study Site Las Vegas Nevada United States 89109
    34 Regeneron Study Site Teaneck New Jersey United States 07666
    35 Regeneron Study Site Bronx New York United States 10451
    36 Regeneron Study Site New York New York United States 10037
    37 Regeneron Study Site Charlotte North Carolina United States 28209
    38 Regeneron Study Site Durham North Carolina United States 27705
    39 Regeneron Study Site Wilmington North Carolina United States 28401
    40 Regeneron Study Site Columbus Ohio United States 43215
    41 Regeneron Study Site Dayton Ohio United States 45409
    42 Regeneron Study Site Dayton Ohio United States 45432
    43 Regeneron Study Site Philadelphia Pennsylvania United States 19140
    44 Regeneron Study Site Charleston South Carolina United States 29425
    45 Regeneron Study Site Clinton South Carolina United States 29325
    46 Regeneron Study Site Amarillo Texas United States 79109
    47 Regeneron Study Site Corpus Christi Texas United States 78413
    48 Regeneron Study Site Houston Texas United States 77008
    49 Regeneron Study Site Houston Texas United States 77030
    50 Regeneron Study Site Houston Texas United States 77057
    51 Regeneron Study Site Houston Texas United States 77093
    52 Regeneron Study Site Pearland Texas United States 77584
    53 Regeneron Study Site Red Oak Texas United States 75154
    54 Regeneron Study Site San Antonio Texas United States 78249
    55 Regeneron Study Site Splendora Texas United States 77372
    56 Regeneron Study Site Tyler Texas United States 75701
    57 Regeneron Study Site Falls Church Virginia United States 22042

    Sponsors and Collaborators

    • Regeneron Pharmaceuticals

    Investigators

    • Study Director: Clinical Trial Management, Regeneron Pharmaceuticals

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    Regeneron Pharmaceuticals
    ClinicalTrials.gov Identifier:
    NCT04666441
    Other Study ID Numbers:
    • R10933-10987-COV-20145
    First Posted:
    Dec 14, 2020
    Last Update Posted:
    Apr 8, 2022
    Last Verified:
    Mar 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Regeneron Pharmaceuticals
    Coronavirus disease 2019 (COVID-19)
    Severe acute respiratory syndrome coronavirus 2 (SARS-COV-2) coronavirus
    Non-hospitalized
    Additional relevant MeSH terms:
    COVID-19

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail A total of 1186 participants were screened and 1149 participants randomized and treated. Reasons for discontinuation at screening phase: 26-Screen Failure, 8-Subject Decision, 1-Sponsor Request, 1-Other. 1 randomized participant was not treated due to lack of supplies.
    Arm/Group Title Placebo IV Dose 300mg IV 600mg IV 1200mg IV 2400mg IV Placebo SC Dose 600mg SC 1200mg SC
    Arm/Group Description Participants received a single intravenous dose of placebo matching REGN10933+REGN10987 Participants received a single 300mg intravenous dose of REGN10933+REGN10987 Participants received a single 600mg intravenous dose of REGN10933+REGN10987 Participants received a single 1200mg intravenous dose of REGN10933+REGN10987 Participants received a single 2400mg intravenous dose of REGN10933+REGN10987 Participants received a single subcutaneous dose of placebo matching REGN10933+REGN10987 Participants received a single 600mg subcutaneous dose of REGN10933+REGN10987 Participants received a single 1200mg subcutaneous dose of REGN10933+REGN10987
    Period Title: Overall Study
    STARTED 82 165 162 165 166 82 163 164
    COMPLETED 80 160 158 161 166 79 158 160
    NOT COMPLETED 2 5 4 4 0 3 5 4

    Baseline Characteristics

    Arm/Group Title Placebo IV Dose 300mg IV 600mg IV 1200mg IV 2400mg IV Placebo SC Dose 600mg SC 1200mg SC Total
    Arm/Group Description Participants received a single intravenous dose of placebo matching REGN10933+REGN10987 Participants received a single 300mg intravenous dose of REGN10933+REGN10987 Participants received a single 600mg intravenous dose of REGN10933+REGN10987 Participants received a single 1200mg intravenous dose of REGN10933+REGN10987 Participants received a single 2400mg intravenous dose of REGN10933+REGN10987 Participants received a single subcutaneous dose of placebo matching REGN10933+REGN10987 Participants received a single 600mg subcutaneous dose of REGN10933+REGN10987 Participants received a single 1200mg subcutaneous dose of REGN10933+REGN10987 Total of all reporting groups
    Overall Participants 82 165 162 165 166 82 163 164 1149
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    33.5
    (10.15)
    33.9
    (8.99)
    34.2
    (10.08)
    34.4
    (9.81)
    33.9
    (9.24)
    36.3
    (9.88)
    33.5
    (9.50)
    33.0
    (10.18)
    34.0
    (9.70)
    Sex: Female, Male (Count of Participants)
    Female
    51
    62.2%
    87
    52.7%
    73
    45.1%
    92
    55.8%
    91
    54.8%
    39
    47.6%
    82
    50.3%
    85
    51.8%
    600
    52.2%
    Male
    31
    37.8%
    78
    47.3%
    89
    54.9%
    73
    44.2%
    75
    45.2%
    43
    52.4%
    81
    49.7%
    79
    48.2%
    549
    47.8%
    Ethnicity (NIH/OMB) (Count of Participants)
    Hispanic or Latino
    26
    31.7%
    67
    40.6%
    58
    35.8%
    60
    36.4%
    73
    44%
    32
    39%
    68
    41.7%
    62
    37.8%
    446
    38.8%
    Not Hispanic or Latino
    55
    67.1%
    96
    58.2%
    98
    60.5%
    102
    61.8%
    91
    54.8%
    49
    59.8%
    94
    57.7%
    99
    60.4%
    684
    59.5%
    Unknown or Not Reported
    1
    1.2%
    2
    1.2%
    6
    3.7%
    3
    1.8%
    2
    1.2%
    1
    1.2%
    1
    0.6%
    3
    1.8%
    19
    1.7%
    Race (NIH/OMB) (Count of Participants)
    American Indian or Alaska Native
    0
    0%
    2
    1.2%
    2
    1.2%
    0
    0%
    0
    0%
    0
    0%
    1
    0.6%
    0
    0%
    5
    0.4%
    Asian
    11
    13.4%
    6
    3.6%
    7
    4.3%
    12
    7.3%
    3
    1.8%
    4
    4.9%
    12
    7.4%
    12
    7.3%
    67
    5.8%
    Native Hawaiian or Other Pacific Islander
    0
    0%
    0
    0%
    1
    0.6%
    2
    1.2%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    3
    0.3%
    Black or African American
    3
    3.7%
    11
    6.7%
    8
    4.9%
    13
    7.9%
    17
    10.2%
    2
    2.4%
    7
    4.3%
    11
    6.7%
    72
    6.3%
    White
    66
    80.5%
    141
    85.5%
    138
    85.2%
    131
    79.4%
    141
    84.9%
    72
    87.8%
    141
    86.5%
    136
    82.9%
    966
    84.1%
    More than one race
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Unknown or Not Reported
    2
    2.4%
    5
    3%
    6
    3.7%
    7
    4.2%
    5
    3%
    4
    4.9%
    2
    1.2%
    5
    3%
    36
    3.1%
    Viral Load in Nasopharyngeal Swab Samples (log10 copies/mL) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [log10 copies/mL]
    5.98
    (2.753)
    6.20
    (2.697)
    5.70
    (3.171)
    5.87
    (2.656)
    6.12
    (2.521)
    6.28
    (2.521)
    6.15
    (2.481)
    5.90
    (2.832)
    6.01
    (2.719)

    Outcome Measures

    1. Primary Outcome
    Title Time-Weighted Average Daily Change From Day 1 in Viral Load in NP Swab Samples
    Description Time-weighted average daily change from Day 1 in viral load (log10 copies/mL), as measured by reverse transcription quantitative polymerase chain reaction (RT-qPCR) in nasopharyngeal (NP) swab samples.
    Time Frame Day 1 to Day 7

    Outcome Measure Data

    Analysis Population Description
    Seronegative modified Full Analysis Set (Seronegative mFAS): Participants in the Full Analysis Set (Overall mFAS) who were seronegative at baseline
    Arm/Group Title Pooled Placebo (IV + SC) 300mg IV 600mg IV 1200mg IV 2400mg IV 600mg SC 1200mg SC
    Arm/Group Description Participants received a single intravenous dose of placebo matching REGN10933+REGN10987 or a single subcutaneous dose of placebo matching REGN10933+REGN10987 Participants received a single 300mg intravenous dose of REGN10933+REGN10987 Participants received a single 600mg intravenous dose of REGN10933+REGN10987 Participants received a single 1200mg intravenous dose of REGN10933+REGN10987 Participants received a single 2400mg intravenous dose of REGN10933+REGN10987 Participants received a single 600mg subcutaneous dose of REGN10933+REGN10987 Participants received a single 1200mg subcutaneous dose of REGN10933+REGN10987
    Measure Participants 74 76 66 67 61 71 71
    Least Squares Mean (Standard Error) [log10 copies/mL]
    -1.68
    (0.11)
    -2.25
    (0.11)
    -2.34
    (0.12)
    -2.24
    (0.12)
    -2.40
    (0.12)
    -2.24
    (0.12)
    -2.24
    (0.12)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Pooled Placebo (IV + SC), 300mg IV
    Comments Difference vs. Placebo (log10 copies/mL)
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0004
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Difference of LS Means
    Estimated Value -0.57
    Confidence Interval (2-Sided) 95%
    -0.88 to -0.25
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.16
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Pooled Placebo (IV + SC), 600mg IV
    Comments Difference vs. Placebo (log10 copies/mL)
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Difference of LS Means
    Estimated Value -0.66
    Confidence Interval (2-Sided) 95%
    -0.99 to -0.34
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.17
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Pooled Placebo (IV + SC), 1200mg IV
    Comments Difference vs. Placebo (log10 copies/mL)
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0007
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Difference of LS Means
    Estimated Value -0.56
    Confidence Interval (2-Sided) 95%
    -0.89 to -0.24
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.16
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Pooled Placebo (IV + SC), 2400mg IV
    Comments Difference vs. Placebo (log10 copies/mL)
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Difference of LS Means
    Estimated Value -0.71
    Confidence Interval (2-Sided) 95%
    -1.05 to -0.38
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.17
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Pooled Placebo (IV + SC), 600mg SC
    Comments Difference vs. Placebo (log10 copies/mL)
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0006
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Difference of LS Means
    Estimated Value -0.56
    Confidence Interval () 95%
    -0.88 to -0.24
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.16
    Estimation Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Pooled Placebo (IV + SC), 1200mg SC
    Comments Difference vs. Placebo (log10 copies/mL)
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0007
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Difference of LS Means
    Estimated Value -0.56
    Confidence Interval () 95%
    -0.87 to -0.24
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.16
    Estimation Comments
    2. Secondary Outcome
    Title Time-Weighted Average Daily Change From Day 1 in Viral Load
    Description Time-weighted average daily change from Day 1 in viral load (log10 copies/mL) as measured by reverse transcription quantitative polymerase chain reaction (RT-qPCR) in nasopharyngeal (NP) swab samples.
    Time Frame Day 1 to Day 5

    Outcome Measure Data

    Analysis Population Description
    Seronegative modified Full Analysis Set (Seronegative mFAS): Participants in the Full Analysis Set (Overall mFAS) who were seronegative at baseline
    Arm/Group Title Pooled Placebo (IV + SC) 300mg IV 600mg IV 1200mg IV 2400mg IV 600mg SC 1200mg SC
    Arm/Group Description Participants received a single intravenous dose of placebo matching REGN10933+REGN10987 or a single subcutaneous dose of placebo matching REGN10933+REGN10987 Participants received a single 300mg intravenous dose of REGN10933+REGN10987 Participants received a single 600mg intravenous dose of REGN10933+REGN10987 Participants received a single 1200mg intravenous dose of REGN10933+REGN10987 Participants received a single 2400mg intravenous dose of REGN10933+REGN10987 Participants received a single 600mg subcutaneous dose of REGN10933+REGN10987 Participants received a single 1200mg subcutaneous dose of REGN10933+REGN10987
    Measure Participants 105 104 96 94 90 99 107
    Least Squares Mean (Standard Error) [log10 copies/mL]
    -1.19
    (0.09)
    -1.66
    (0.09)
    -1.76
    (0.09)
    -1.77
    (0.09)
    -1.68
    (0.10)
    -1.56
    (0.09)
    -1.61
    (0.09)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Pooled Placebo (IV + SC), 300mg IV
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0002
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Difference of LS Means
    Estimated Value -0.47
    Confidence Interval () 95%
    -0.72 to -0.23
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.13
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Pooled Placebo (IV + SC), 600mg IV
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Difference of LS Means
    Estimated Value -0.57
    Confidence Interval () 95%
    -0.82 to -0.32
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.13
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Pooled Placebo (IV + SC), 1200mg IV
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Difference of LS Means
    Estimated Value -0.58
    Confidence Interval () 95%
    -0.83 to -0.33
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.13
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Pooled Placebo (IV + SC), 2400mg IV
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0002
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Difference of LS Means
    Estimated Value -0.49
    Confidence Interval () 95%
    -0.75 to -0.24
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.13
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Pooled Placebo (IV + SC), 600mg SC
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0040
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Difference of LS Means
    Estimated Value -0.37
    Confidence Interval () 95%
    -0.62 to -0.12
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.13
    Estimation Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Pooled Placebo (IV + SC), 1200mg SC
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0007
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Difference of LS Means
    Estimated Value -0.42
    Confidence Interval () 95%
    -0.67 to -0.18
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.12
    Estimation Comments
    3. Secondary Outcome
    Title Time-Weighted Average Daily Change From Day 1 in Viral Load in Participants With High Viral Load at Baseline
    Description Time-weighted average daily change from Day 1 in viral load (log10 copies/mL) as measured by reverse transcription quantitative polymerase chain reaction (RT-qPCR) in nasopharyngeal (NP) swab samples. in any participant with a viral load greater than 10,000 copies/mL at baseline.
    Time Frame Day 1 to Day 7

    Outcome Measure Data

    Analysis Population Description
    Overall modified Full Analysis Set (Overall mFAS): All randomized participants with a positive central-lab determined SARS-CoV-2 RT-qPCR result from NP swab samples at randomization; based on the treatment received (as treated)
    Arm/Group Title Pooled Placebo (IV + SC) 300mg IV 600mg IV 1200mg IV 2400mg IV 600mg SC 1200mg SC
    Arm/Group Description Participants received a single intravenous dose of placebo matching REGN10933+REGN10987 or a single subcutaneous dose of placebo matching REGN10933+REGN10987 Participants received a single 300mg intravenous dose of REGN10933+REGN10987 Participants received a single 600mg intravenous dose of REGN10933+REGN10987 Participants received a single 1200mg intravenous dose of REGN10933+REGN10987 Participants received a single 2400mg intravenous dose of REGN10933+REGN10987 Participants received a single 600mg subcutaneous dose of REGN10933+REGN10987 Participants received a single 1200mg subcutaneous dose of REGN10933+REGN10987
    Measure Participants 134 136 119 128 136 133 130
    Baseline Viral Load is >10^4 copies/mL
    -1.79
    (0.09)
    -2.36
    (0.09)
    -2.37
    (0.09)
    -2.41
    (0.09)
    -2.34
    (0.09)
    -2.30
    (0.09)
    -2.27
    (0.09)
    Baseline Viral Load is >10^5 copies/mL
    -1.82
    (0.09)
    -2.47
    (0.09)
    -2.51
    (0.10)
    -2.49
    (0.09)
    -2.46
    (0.09)
    -2.40
    (0.09)
    -2.38
    (0.09)
    Baseline Viral Load is >10^6 copies/mL
    -1.92
    (0.10)
    -2.62
    (0.10)
    -2.63
    (0.10)
    -2.64
    (0.10)
    -2.62
    (0.10)
    -2.47
    (0.10)
    -2.52
    (0.10)
    Baseline Viral Load is >10^7 copies/mL
    -1.89
    (0.11)
    -2.77
    (0.11)
    -2.83
    (0.11)
    -2.82
    (0.12)
    -2.72
    (0.11)
    -2.52
    (0.11)
    -2.73
    (0.11)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Pooled Placebo (IV + SC), 300mg IV
    Comments Baseline Viral Load >10^4 copies/mL Difference vs. Placebo (log10 copies/mL)
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Difference of LS Means
    Estimated Value -0.57
    Confidence Interval (2-Sided) 95%
    -0.82 to -0.33
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.13
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Pooled Placebo (IV + SC), 300mg IV
    Comments Baseline Viral Load >10^5 copies/mL Difference vs. Placebo (log10 copies/mL)
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Difference of LS Means
    Estimated Value -0.65
    Confidence Interval (2-Sided) 95%
    -0.90 to -0.40
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.13
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Pooled Placebo (IV + SC), 300mg IV
    Comments Baseline Viral Load >10^6 copies/mL Difference vs. Placebo (log10 copies/mL)
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Difference of LS Means
    Estimated Value -0.70
    Confidence Interval (2-Sided) 95%
    -0.97 to -0.42
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.14
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Pooled Placebo (IV + SC), 300mg IV
    Comments Baseline Viral Load >10^7 copies/mL Difference vs. Placebo (log10 copies/mL)
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Difference of LS Means
    Estimated Value -0.88
    Confidence Interval (2-Sided) 95%
    -1.19 to -0.58
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.16
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Pooled Placebo (IV + SC), 600mg IV
    Comments Baseline Viral Load >10^4 copies/mL Difference vs. Placebo (log10 copies/mL)
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Difference of LS Means
    Estimated Value -0.58
    Confidence Interval (2-Sided) 95%
    -0.84 to -0.33
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.13
    Estimation Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Pooled Placebo (IV + SC), 600mg IV
    Comments Baseline Viral Load >10^5 copies/mL Difference vs. Placebo (log10 copies/mL)
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Difference of LS Means
    Estimated Value -0.69
    Confidence Interval (2-Sided) 95%
    -0.95 to -0.43
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.13
    Estimation Comments
    Statistical Analysis 7
    Statistical Analysis Overview Comparison Group Selection Pooled Placebo (IV + SC), 600mg IV
    Comments Baseline Viral Load >10^6 copies/mL Difference vs. Placebo (log10 copies/mL)
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Difference of LS Means
    Estimated Value -0.71
    Confidence Interval (2-Sided) 95%
    -0.98 to -0.44
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.14
    Estimation Comments
    Statistical Analysis 8
    Statistical Analysis Overview Comparison Group Selection Pooled Placebo (IV + SC), 600mg IV
    Comments Baseline Viral Load >10^7 copies/mL Difference vs. Placebo (log10 copies/mL)
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Difference of LS Means
    Estimated Value -0.95
    Confidence Interval (2-Sided) 95%
    -1.25 to -0.64
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.16
    Estimation Comments
    Statistical Analysis 9
    Statistical Analysis Overview Comparison Group Selection Pooled Placebo (IV + SC), 1200mg IV
    Comments Baseline Viral Load >10^4 copies/mL Difference vs. Placebo (log10 copies/mL)
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Difference of LS Means
    Estimated Value -0.62
    Confidence Interval (2-Sided) 95%
    -0.87 to -0.37
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.13
    Estimation Comments
    Statistical Analysis 10
    Statistical Analysis Overview Comparison Group Selection Pooled Placebo (IV + SC), 1200mg IV
    Comments Baseline Viral Load >10^5 copies/mL Difference vs. Placebo (log10 copies/mL)
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Difference of LS Means
    Estimated Value -0.67
    Confidence Interval (2-Sided) 95%
    -0.93 to -0.42
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.13
    Estimation Comments
    Statistical Analysis 11
    Statistical Analysis Overview Comparison Group Selection Pooled Placebo (IV + SC), 1200mg IV
    Comments Baseline Viral Load >10^6 copies/mL Difference vs. Placebo (log10 copies/mL)
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Difference of LS Means
    Estimated Value -0.72
    Confidence Interval (2-Sided) 95%
    -0.99 to -0.44
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.14
    Estimation Comments
    Statistical Analysis 12
    Statistical Analysis Overview Comparison Group Selection Pooled Placebo (IV + SC), 1200mg IV
    Comments Baseline Viral Load >10^7 copies/mL Difference vs. Placebo (log10 copies/mL)
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Difference of LS Means
    Estimated Value -0.93
    Confidence Interval (2-Sided) 95%
    -1.25 to -0.61
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.16
    Estimation Comments
    Statistical Analysis 13
    Statistical Analysis Overview Comparison Group Selection Pooled Placebo (IV + SC), 2400mg IV
    Comments Baseline Viral Load >10^4 copies/mL Difference vs. Placebo (log10 copies/mL)
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Difference of LS Means
    Estimated Value -0.56
    Confidence Interval (2-Sided) 95%
    -0.80 to -0.31
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.13
    Estimation Comments
    Statistical Analysis 14
    Statistical Analysis Overview Comparison Group Selection Pooled Placebo (IV + SC), 2400mg IV
    Comments Baseline Viral Load >10^5 copies/mL Difference vs. Placebo (log10 copies/mL)
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Difference of LS Means
    Estimated Value -0.64
    Confidence Interval (2-Sided) 95%
    -0.89 to -0.38
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.13
    Estimation Comments
    Statistical Analysis 15
    Statistical Analysis Overview Comparison Group Selection Pooled Placebo (IV + SC), 2400mg IV
    Comments Baseline Viral Load >10^6 copies/mL Difference vs. Placebo (log10 copies/mL)
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Difference of LS Means
    Estimated Value -0.70
    Confidence Interval (2-Sided) 95%
    -0.97 to -0.43
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.14
    Estimation Comments
    Statistical Analysis 16
    Statistical Analysis Overview Comparison Group Selection Pooled Placebo (IV + SC), 2400mg IV
    Comments Baseline Viral Load >10^7 copies/mL Difference vs. Placebo (log10 copies/mL)
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Difference of LS Means
    Estimated Value -0.84
    Confidence Interval (2-Sided) 95%
    -1.15 to -0.52
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.16
    Estimation Comments
    Statistical Analysis 17
    Statistical Analysis Overview Comparison Group Selection Pooled Placebo (IV + SC), 600mg SC
    Comments Baseline Viral Load >10^4 copies/mL Difference vs. Placebo (log10 copies/mL)
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Difference of LS Means
    Estimated Value -0.51
    Confidence Interval (2-Sided) 95%
    -0.76 to -0.27
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.13
    Estimation Comments
    Statistical Analysis 18
    Statistical Analysis Overview Comparison Group Selection Pooled Placebo (IV + SC), 600mg SC
    Comments Baseline Viral Load >10^5 copies/mL Difference vs. Placebo (log10 copies/mL)
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Difference of LS Means
    Estimated Value -0.58
    Confidence Interval (2-Sided) 95%
    -0.83 to -0.33
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.13
    Estimation Comments
    Statistical Analysis 19
    Statistical Analysis Overview Comparison Group Selection Pooled Placebo (IV + SC), 600mg SC
    Comments Baseline Viral Load >10^6 copies/mL Difference vs. Placebo (log10 copies/mL)
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Difference of LS Means
    Estimated Value -0.55
    Confidence Interval (2-Sided) 95%
    -0.82 to -0.28
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.14
    Estimation Comments
    Statistical Analysis 20
    Statistical Analysis Overview Comparison Group Selection Pooled Placebo (IV + SC), 600mg SC
    Comments Baseline Viral Load >10^7 copies/mL Difference vs. Placebo (log10 copies/mL)
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Difference of LS Means
    Estimated Value -0.63
    Confidence Interval (2-Sided) 95%
    -0.95 to -0.32
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.16
    Estimation Comments
    Statistical Analysis 21
    Statistical Analysis Overview Comparison Group Selection Pooled Placebo (IV + SC), 1200mg SC
    Comments Baseline Viral Load >10^4 copies/mL Difference vs. Placebo (log10 copies/mL)
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0002
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Difference of LS Means
    Estimated Value -0.48
    Confidence Interval (2-Sided) 95%
    -0.73 to -0.23
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.13
    Estimation Comments
    Statistical Analysis 22
    Statistical Analysis Overview Comparison Group Selection Pooled Placebo (IV + SC), 1200mg SC
    Comments Baseline Viral Load >10^5 copies/mL Difference vs. Placebo (log10 copies/mL)
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Difference of LS Means
    Estimated Value -0.56
    Confidence Interval (2-Sided) 95%
    -0.82 to -0.31
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.13
    Estimation Comments
    Statistical Analysis 23
    Statistical Analysis Overview Comparison Group Selection Pooled Placebo (IV + SC), 1200mg SC
    Comments Baseline Viral Load >10^6 copies/mL Difference vs. Placebo (log10 copies/mL)
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Difference of LS Means
    Estimated Value -0.60
    Confidence Interval (2-Sided) 95%
    -0.87 to -0.33
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.14
    Estimation Comments
    Statistical Analysis 24
    Statistical Analysis Overview Comparison Group Selection Pooled Placebo (IV + SC), 1200mg SC
    Comments Baseline Viral Load >10^7 copies/mL Difference vs. Placebo (log10 copies/mL)
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Difference of LS Means
    Estimated Value -0.84
    Confidence Interval (2-Sided) 95%
    -1.16 to -0.52
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.16
    Estimation Comments
    4. Secondary Outcome
    Title Time-Weighted Average Daily Change From Day 1 in Viral Load in Participants With High Viral Load at Baseline
    Description Time-weighted average daily change from Day 1 in viral load (log10 copies/mL) as measured by reverse transcription quantitative polymerase chain reaction (RT-qPCR) in nasopharyngeal (NP) swab samples. in any participant with a viral load greater than 10,000 copies/mL at baseline.
    Time Frame Day 1 to Day 5

    Outcome Measure Data

    Analysis Population Description
    Overall modified Full Analysis Set (Overall mFAS): All randomized participants with a positive central-lab determined SARS-CoV-2 RT-qPCR result from NP swab samples at randomization; based on the treatment received (as treated)
    Arm/Group Title Pooled Placebo (IV + SC) 300mg IV 600mg IV 1200mg IV 2400mg IV 600mg SC 1200mg SC
    Arm/Group Description Participants received a single intravenous dose of placebo matching REGN10933+REGN10987 or a single subcutaneous dose of placebo matching REGN10933+REGN10987 Participants received a single 300mg intravenous dose of REGN10933+REGN10987 Participants received a single 600mg intravenous dose of REGN10933+REGN10987 Participants received a single 1200mg intravenous dose of REGN10933+REGN10987 Participants received a single 2400mg intravenous dose of REGN10933+REGN10987 Participants received a single 600mg subcutaneous dose of REGN10933+REGN10987 Participants received a single 1200mg subcutaneous dose of REGN10933+REGN10987
    Measure Participants 128 131 115 124 132 128 126
    Baseline Viral Load is >10^4 copies/mL
    -1.28
    (0.08)
    -1.69
    (0.08)
    -1.73
    (0.09)
    -1.76
    (0.09)
    -1.68
    (0.08)
    -1.62
    (0.08)
    -1.61
    (0.08)
    Baseline Viral Load is >10^5 copies/mL
    -1.30
    (0.08)
    -1.77
    (0.08)
    -1.83
    (0.09)
    -1.81
    (0.09)
    -1.76
    (0.09)
    -1.69
    (0.08)
    -1.69
    (0.09)
    Baseline Viral Load is >10^6 copies/mL
    -1.38
    (0.09)
    -1.89
    (0.09)
    -1.92
    (0.09)
    -1.93
    (0.09)
    -1.91
    (0.09)
    -1.76
    (0.09)
    -1.79
    (0.09)
    Baseline Viral Load is >10^7 copies/mL
    -1.39
    (0.11)
    -1.99
    (0.10)
    -2.08
    (0.10)
    -2.08
    (0.11)
    -2.01
    (0.10)
    -1.76
    (0.10)
    -1.97
    (0.10)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Pooled Placebo (IV + SC), 300mg IV
    Comments Baseline Viral Load >10^4 copies/mL Difference vs. Placebo (log10 copies/mL)
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0005
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Difference of LS Means
    Estimated Value -0.41
    Confidence Interval (2-Sided) 95%
    -0.64 to -0.18
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.12
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Pooled Placebo (IV + SC), 300mg IV
    Comments Baseline Viral Load >10^5 copies/mL Difference vs. Placebo (log10 copies/mL)
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Difference of LS Means
    Estimated Value -0.46
    Confidence Interval (2-Sided) 95%
    -0.69 to -0.23
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.12
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Pooled Placebo (IV + SC), 300mg IV
    Comments Baseline Viral Load >10^6 copies/mL Difference vs. Placebo (log10 copies/mL)
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Difference of LS Means
    Estimated Value -0.51
    Confidence Interval (2-Sided) 95%
    -0.75 to -0.26
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.13
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Pooled Placebo (IV + SC), 300mg IV
    Comments Baseline Viral Load >10^7 copies/mL Difference vs. Placebo (log10 copies/mL)
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Difference of LS Means
    Estimated Value -0.60
    Confidence Interval (2-Sided) 95%
    -0.88 to -0.32
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.14
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Pooled Placebo (IV + SC), 600mg IV
    Comments Baseline Viral Load >10^4 copies/mL Difference vs. Placebo (log10 copies/mL)
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0003
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Difference of LS Means
    Estimated Value -0.45
    Confidence Interval (2-Sided) 95%
    -0.69 to -0.21
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.12
    Estimation Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Pooled Placebo (IV + SC), 600mg IV
    Comments Baseline Viral Load >10^5 copies/mL Difference vs. Placebo (log10 copies/mL)
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Difference of LS Means
    Estimated Value -0.53
    Confidence Interval (2-Sided) 95%
    -0.77 to -0.29
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.12
    Estimation Comments
    Statistical Analysis 7
    Statistical Analysis Overview Comparison Group Selection Pooled Placebo (IV + SC), 600mg IV
    Comments Baseline Viral Load >10^6 copies/mL Difference vs. Placebo (log10 copies/mL)
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Difference of LS Means
    Estimated Value -0.53
    Confidence Interval (2-Sided) 95%
    -0.78 to -0.29
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.13
    Estimation Comments
    Statistical Analysis 8
    Statistical Analysis Overview Comparison Group Selection Pooled Placebo (IV + SC), 600mg IV
    Comments Baseline Viral Load >10^7 copies/mL Difference vs. Placebo (log10 copies/mL)
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Difference of LS Means
    Estimated Value -0.69
    Confidence Interval (2-Sided) 95%
    -0.98 to -0.41
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.14
    Estimation Comments
    Statistical Analysis 9
    Statistical Analysis Overview Comparison Group Selection Pooled Placebo (IV + SC), 1200mg IV
    Comments Baseline Viral Load >10^4 copies/mL Difference vs. Placebo (log10 copies/mL)
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Difference of LS Means
    Estimated Value -0.48
    Confidence Interval (2-Sided) 95%
    -0.72 to -0.25
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.12
    Estimation Comments
    Statistical Analysis 10
    Statistical Analysis Overview Comparison Group Selection Pooled Placebo (IV + SC), 1200mg IV
    Comments Baseline Viral Load >10^5 copies/mL Difference vs. Placebo (log10 copies/mL)
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Difference of LS Means
    Estimated Value -0.51
    Confidence Interval (2-Sided) 95%
    -0.74 to -0.28
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.12
    Estimation Comments
    Statistical Analysis 11
    Statistical Analysis Overview Comparison Group Selection Pooled Placebo (IV + SC), 1200mg IV
    Comments Baseline Viral Load >10^6 copies/mL Difference vs. Placebo (log10 copies/mL)
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Difference of LS Means
    Estimated Value -0.54
    Confidence Interval (2-Sided) 95%
    -0.79 to -0.30
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.13
    Estimation Comments
    Statistical Analysis 12
    Statistical Analysis Overview Comparison Group Selection Pooled Placebo (IV + SC), 1200mg IV
    Comments Baseline Viral Load >10^7 copies/mL Difference vs. Placebo (log10 copies/mL)
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Difference of LS Means
    Estimated Value -0.70
    Confidence Interval (2-Sided) 95%
    -0.99 to -0.40
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.15
    Estimation Comments
    Statistical Analysis 13
    Statistical Analysis Overview Comparison Group Selection Pooled Placebo (IV + SC), 2400mg IV
    Comments Baseline Viral Load >10^4 copies/mL Difference vs. Placebo (log10 copies/mL)
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0009
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Difference of LS Means
    Estimated Value -0.39
    Confidence Interval (2-Sided) 95%
    -0.63 to -0.16
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.12
    Estimation Comments
    Statistical Analysis 14
    Statistical Analysis Overview Comparison Group Selection Pooled Placebo (IV + SC), 2400mg IV
    Comments Baseline Viral Load >10^5 copies/mL Difference vs. Placebo (log10 copies/mL)
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0001
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Difference of LS Means
    Estimated Value -0.46
    Confidence Interval (2-Sided) 95%
    -0.69 to -0.23
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.12
    Estimation Comments
    Statistical Analysis 15
    Statistical Analysis Overview Comparison Group Selection Pooled Placebo (IV + SC), 2400mg IV
    Comments Baseline Viral Load >10^6 copies/mL Difference vs. Placebo (log10 copies/mL)
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Difference of LS Means
    Estimated Value -0.52
    Confidence Interval (2-Sided) 95%
    -0.77 to -0.27
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.13
    Estimation Comments
    Statistical Analysis 16
    Statistical Analysis Overview Comparison Group Selection Pooled Placebo (IV + SC), 2400mg IV
    Comments Baseline Viral Load >10^7 copies/mL Difference vs. Placebo (log10 copies/mL)
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Difference of LS Means
    Estimated Value -0.63
    Confidence Interval (2-Sided) 95%
    -0.92 to -0.34
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.15
    Estimation Comments
    Statistical Analysis 17
    Statistical Analysis Overview Comparison Group Selection Pooled Placebo (IV + SC), 600mg SC
    Comments Baseline Viral Load >10^4 copies/mL Difference vs. Placebo (log10 copies/mL)
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0046
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Difference of LS Means
    Estimated Value -0.34
    Confidence Interval (2-Sided) 95%
    -0.57 to -0.10
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.12
    Estimation Comments
    Statistical Analysis 18
    Statistical Analysis Overview Comparison Group Selection Pooled Placebo (IV + SC), 600mg SC
    Comments Baseline Viral Load >10^5 copies/mL Difference vs. Placebo (log10 copies/mL)
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0011
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Difference of LS Means
    Estimated Value -0.39
    Confidence Interval (2-Sided) 95%
    -0.62 to -0.15
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.12
    Estimation Comments
    Statistical Analysis 19
    Statistical Analysis Overview Comparison Group Selection Pooled Placebo (IV + SC), 600mg SC
    Comments Baseline Viral Load >10^6 copies/mL Difference vs. Placebo (log10 copies/mL)
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0029
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Difference of LS Means
    Estimated Value -0.37
    Confidence Interval (2-Sided) 95%
    -0.62 to -0.13
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.13
    Estimation Comments
    Statistical Analysis 20
    Statistical Analysis Overview Comparison Group Selection Pooled Placebo (IV + SC), 600mg SC
    Comments Baseline Viral Load >10^7 copies/mL Difference vs. Placebo (log10 copies/mL)
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0120
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Difference of LS Means
    Estimated Value -0.37
    Confidence Interval (2-Sided) 95%
    -0.66 to -0.08
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.15
    Estimation Comments
    Statistical Analysis 21
    Statistical Analysis Overview Comparison Group Selection Pooled Placebo (IV + SC), 1200mg SC
    Comments Baseline Viral Load >10^4 copies/mL Difference vs. Placebo (log10 copies/mL)
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0062
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Difference of LS Means
    Estimated Value -0.33
    Confidence Interval (2-Sided) 95%
    -0.56 to -0.09
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.12
    Estimation Comments
    Statistical Analysis 22
    Statistical Analysis Overview Comparison Group Selection Pooled Placebo (IV + SC), 1200mg SC
    Comments Baseline Viral Load >10^5 copies/mL Difference vs. Placebo (log10 copies/mL)
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0011
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Difference of LS Means
    Estimated Value -0.39
    Confidence Interval (2-Sided) 95%
    -0.62 to -0.16
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.12
    Estimation Comments
    Statistical Analysis 23
    Statistical Analysis Overview Comparison Group Selection Pooled Placebo (IV + SC), 1200mg SC
    Comments Baseline Viral Load >10^6 copies/mL Difference vs. Placebo (log10 copies/mL)
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0011
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Difference of LS Means
    Estimated Value -0.41
    Confidence Interval (2-Sided) 95%
    -0.66 to -0.17
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.13
    Estimation Comments
    Statistical Analysis 24
    Statistical Analysis Overview Comparison Group Selection Pooled Placebo (IV + SC), 1200mg SC
    Comments Baseline Viral Load >10^7 copies/mL Difference vs. Placebo (log10 copies/mL)
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0001
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Difference of LS Means
    Estimated Value -0.58
    Confidence Interval (2-Sided) 95%
    -0.87 to -0.29
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.15
    Estimation Comments
    5. Secondary Outcome
    Title Number of Participants With High Viral Load
    Description Number of participants with viral load greater than 10,000 copies/mL, as measured by reverse transcription quantitative polymerase chain reaction (RT-qPCR) in nasopharyngeal (NP) swab samples.
    Time Frame Day 1, Day 3, Day 5, Day 7, Day 15, Day 22

    Outcome Measure Data

    Analysis Population Description
    Seronegative modified Full Analysis Set (Seronegative mFAS): Participants in the Full Analysis Set (Overall mFAS) who were seronegative at baseline
    Arm/Group Title Pooled Placebo (IV + SC) 300mg IV 600mg IV 1200mg IV 2400mg IV 600mg SC 1200mg SC
    Arm/Group Description Participants received a single intravenous dose of placebo matching REGN10933+REGN10987 or a single subcutaneous dose of placebo matching REGN10933+REGN10987 Participants received a single 300mg intravenous dose of REGN10933+REGN10987 Participants received a single 600mg intravenous dose of REGN10933+REGN10987 Participants received a single 1200mg intravenous dose of REGN10933+REGN10987 Participants received a single 2400mg intravenous dose of REGN10933+REGN10987 Participants received a single 600mg subcutaneous dose of REGN10933+REGN10987 Participants received a single 1200mg subcutaneous dose of REGN10933+REGN10987
    Measure Participants 109 108 100 97 93 103 111
    Day 1 Viral Load >10^4 copies/mL
    108
    131.7%
    106
    64.2%
    96
    59.3%
    95
    57.6%
    91
    54.8%
    99
    120.7%
    106
    65%
    Day 1 Viral Load >10^5 copies/mL
    104
    126.8%
    99
    60%
    92
    56.8%
    89
    53.9%
    84
    50.6%
    93
    113.4%
    95
    58.3%
    Day 1 Viral Load >10^6 copies/mL
    88
    107.3%
    83
    50.3%
    86
    53.1%
    76
    46.1%
    78
    47%
    81
    98.8%
    88
    54%
    Day 1 Viral Load >10^7 copies/mL
    60
    73.2%
    67
    40.6%
    64
    39.5%
    54
    32.7%
    58
    34.9%
    63
    76.8%
    62
    38%
    Day 3 Viral Load >10^4 copies/mL
    93
    113.4%
    92
    55.8%
    79
    48.8%
    80
    48.5%
    80
    48.2%
    89
    108.5%
    89
    54.6%
    Day 3 Viral Load >10^5 copies/mL
    83
    101.2%
    68
    41.2%
    63
    38.9%
    67
    40.6%
    61
    36.7%
    68
    82.9%
    75
    46%
    Day 3 Viral Load >10^6 copies/mL
    59
    72%
    47
    28.5%
    43
    26.5%
    36
    21.8%
    39
    23.5%
    41
    50%
    53
    32.5%
    Day 3 Viral Load >10^7 copies/mL
    29
    35.4%
    15
    9.1%
    15
    9.3%
    14
    8.5%
    14
    8.4%
    25
    30.5%
    23
    14.1%
    Day 5 Viral Load >10^4 copies/mL
    78
    95.1%
    65
    39.4%
    58
    35.8%
    58
    35.2%
    55
    33.1%
    62
    75.6%
    67
    41.1%
    Day 5 Viral Load >10^5 copies/mL
    53
    64.6%
    31
    18.8%
    20
    12.3%
    30
    18.2%
    29
    17.5%
    29
    35.4%
    31
    19%
    Day 5 Viral Load >10^6 copies/mL
    29
    35.4%
    7
    4.2%
    9
    5.6%
    3
    1.8%
    10
    6%
    7
    8.5%
    9
    5.5%
    Day 5 Viral Load >10^7 copies/mL
    14
    17.1%
    0
    0%
    3
    1.9%
    0
    0%
    0
    0%
    5
    6.1%
    2
    1.2%
    Day 7 Viral Load >10^4 copies/mL
    59
    72%
    32
    19.4%
    35
    21.6%
    27
    16.4%
    28
    16.9%
    33
    40.2%
    35
    21.5%
    Day 7 Viral Load >10^5 copies/mL
    32
    39%
    9
    5.5%
    9
    5.6%
    7
    4.2%
    13
    7.8%
    9
    11%
    9
    5.5%
    Day 7 Viral Load >10^6 copies/mL
    13
    15.9%
    2
    1.2%
    1
    0.6%
    0
    0%
    0
    0%
    2
    2.4%
    1
    0.6%
    Day 7 Viral Load >10^7 copies/mL
    5
    6.1%
    1
    0.6%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    1
    0.6%
    Day 15 Viral Load >10^4 copies/mL
    8
    9.8%
    3
    1.8%
    6
    3.7%
    7
    4.2%
    7
    4.2%
    4
    4.9%
    4
    2.5%
    Day 15 Viral Load >10^5 copies/mL
    4
    4.9%
    1
    0.6%
    2
    1.2%
    3
    1.8%
    1
    0.6%
    1
    1.2%
    0
    0%
    Day 15 Viral Load >10^6 copies/mL
    1
    1.2%
    1
    0.6%
    1
    0.6%
    0
    0%
    1
    0.6%
    1
    1.2%
    0
    0%
    Day 15 Viral Load >10^7 copies/mL
    0
    0%
    1
    0.6%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Day 22 Viral Load >10^4 copies/mL
    3
    3.7%
    0
    0%
    3
    1.9%
    0
    0%
    4
    2.4%
    1
    1.2%
    3
    1.8%
    Day 22 Viral Load >10^5 copies/mL
    2
    2.4%
    0
    0%
    0
    0%
    0
    0%
    1
    0.6%
    1
    1.2%
    0
    0%
    Day 22 Viral Load >10^6 copies/mL
    1
    1.2%
    0
    0%
    0
    0%
    0
    0%
    1
    0.6%
    0
    0%
    0
    0%
    Day 22 Viral Load >10^7 copies/mL
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    1
    0.6%
    0
    0%
    0
    0%
    6. Secondary Outcome
    Title Number of Participants With Viral Loads Below the Limit of Detection
    Description Number of participants with viral load less than 299 copies/mL, as measured by reverse transcription quantitative polymerase chain reaction (RT-qPCR) in nasopharyngeal (NP) swab samples.
    Time Frame Day 1, Day 3, Day 5, Day 7, Day 15, Day 22

    Outcome Measure Data

    Analysis Population Description
    Seronegative modified Full Analysis Set (Seronegative mFAS): Participants in the Full Analysis Set (Overall mFAS) who were seronegative at baseline
    Arm/Group Title Pooled Placebo (IV + SC) 300mg IV 600mg IV 1200mg IV 2400mg IV 600mg SC 1200mg SC
    Arm/Group Description Participants received a single intravenous dose of placebo matching REGN10933+REGN10987 or a single subcutaneous dose of placebo matching REGN10933+REGN10987 Participants received a single 300mg intravenous dose of REGN10933+REGN10987 Participants received a single 600mg intravenous dose of REGN10933+REGN10987 Participants received a single 1200mg intravenous dose of REGN10933+REGN10987 Participants received a single 2400mg intravenous dose of REGN10933+REGN10987 Participants received a single 600mg subcutaneous dose of REGN10933+REGN10987 Participants received a single 1200mg subcutaneous dose of REGN10933+REGN10987
    Measure Participants 109 108 100 97 93 103 111
    Day 1
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Day 3
    3
    3.7%
    1
    0.6%
    4
    2.5%
    3
    1.8%
    1
    0.6%
    1
    1.2%
    5
    3.1%
    Day 5
    6
    7.3%
    11
    6.7%
    10
    6.2%
    12
    7.3%
    12
    7.2%
    11
    13.4%
    12
    7.4%
    Day 7
    19
    23.2%
    22
    13.3%
    16
    9.9%
    14
    8.5%
    18
    10.8%
    25
    30.5%
    19
    11.7%
    Day 15
    55
    67.1%
    68
    41.2%
    58
    35.8%
    54
    32.7%
    50
    30.1%
    67
    81.7%
    65
    39.9%
    Day 22
    73
    89%
    78
    47.3%
    74
    45.7%
    70
    42.4%
    62
    37.3%
    81
    98.8%
    84
    51.5%
    7. Secondary Outcome
    Title Number of Participants With Viral Loads Below the Lower Limit of Quantification
    Description Number of participants with viral load less than 714 copies/mL, as measured by reverse transcription quantitative polymerase chain reaction (RT-qPCR) in nasopharyngeal (NP) swab samples.
    Time Frame Day 1, Day 3, Day 5, Day 7, Day 15, Day 22

    Outcome Measure Data

    Analysis Population Description
    Seronegative modified Full Analysis Set (Seronegative mFAS): Participants in the Full Analysis Set (Overall mFAS) who were seronegative at baseline
    Arm/Group Title Pooled Placebo (IV + SC) 300mg IV 600mg IV 1200mg IV 2400mg IV 600mg SC 1200mg SC
    Arm/Group Description Participants received a single intravenous dose of placebo matching REGN10933+REGN10987 or a single subcutaneous dose of placebo matching REGN10933+REGN10987 Participants received a single 300mg intravenous dose of REGN10933+REGN10987 Participants received a single 600mg intravenous dose of REGN10933+REGN10987 Participants received a single 1200mg intravenous dose of REGN10933+REGN10987 Participants received a single 2400mg intravenous dose of REGN10933+REGN10987 Participants received a single 600mg subcutaneous dose of REGN10933+REGN10987 Participants received a single 1200mg subcutaneous dose of REGN10933+REGN10987
    Measure Participants 109 108 100 97 93 103 111
    Day 1
    0
    0%
    1
    0.6%
    0
    0%
    0
    0%
    0
    0%
    3
    3.7%
    0
    0%
    Day 3
    4
    4.9%
    5
    3%
    4
    2.5%
    6
    3.6%
    2
    1.2%
    1
    1.2%
    7
    4.3%
    Day 5
    8
    9.8%
    17
    10.3%
    14
    8.6%
    20
    12.1%
    14
    8.4%
    15
    18.3%
    14
    8.6%
    Day 7
    25
    30.5%
    33
    20%
    24
    14.8%
    26
    15.8%
    24
    14.5%
    38
    46.3%
    27
    16.6%
    Day 15
    69
    84.1%
    78
    47.3%
    69
    42.6%
    67
    40.6%
    62
    37.3%
    76
    92.7%
    83
    50.9%
    Day 22
    84
    102.4%
    87
    52.7%
    83
    51.2%
    81
    49.1%
    74
    44.6%
    87
    106.1%
    95
    58.3%
    8. Secondary Outcome
    Title Change From Day 1 in Viral Load as Measured by RT-qPCR in NP Swab Samples
    Description Change from Day 1 in Viral Load (log10 copies/mL) as Measured by Quantitative reverse transcription polymerase chain reaction (RT-qPCR) in nasopharyngeal (NP) Swab Samples
    Time Frame Day 3, Day 5, Day 7, Day 15, Day 22

    Outcome Measure Data

    Analysis Population Description
    Seronegative modified Full Analysis Set (Seronegative mFAS): Participants in the Full Analysis Set (Overall mFAS) who were seronegative at baseline
    Arm/Group Title Pooled Placebo (IV + SC) 300mg IV 600mg IV 1200mg IV 2400mg IV 600mg SC 1200mg SC
    Arm/Group Description Participants received a single intravenous dose of placebo matching REGN10933+REGN10987 or a single subcutaneous dose of placebo matching REGN10933+REGN10987 Participants received a single 300mg intravenous dose of REGN10933+REGN10987 Participants received a single 600mg intravenous dose of REGN10933+REGN10987 Participants received a single 1200mg intravenous dose of REGN10933+REGN10987 Participants received a single 2400mg intravenous dose of REGN10933+REGN10987 Participants received a single 600mg subcutaneous dose of REGN10933+REGN10987 Participants received a single 1200mg subcutaneous dose of REGN10933+REGN10987
    Measure Participants 109 108 100 97 93 103 111
    Day 3 change from Day 1
    -1.22
    (0.13)
    -1.71
    (0.13)
    -1.91
    (0.14)
    -1.85
    (0.14)
    -1.69
    (0.14)
    -1.55
    (0.13)
    -1.65
    (0.13)
    Day 5 change from Day 1
    -2.29
    (0.16)
    -3.24
    (0.16)
    -3.37
    (0.16)
    -3.32
    (0.17)
    -3.33
    (0.17)
    -3.19
    (0.16)
    -3.20
    (0.16)
    Day 7 change from Day 1
    -3.44
    (0.16)
    -4.24
    (0.16)
    -4.08
    (0.16)
    -4.10
    (0.17)
    -4.17
    (0.17)
    -4.33
    (0.16)
    -4.04
    (0.16)
    Day 15 change from Day 1
    -5.66
    (0.16)
    -6.11
    (0.16)
    -5.97
    (0.17)
    -5.91
    (0.17)
    -5.77
    (0.17)
    -6.17
    (0.17)
    -6.05
    (0.16)
    Day 22 change from Day 1
    -6.27
    (0.13)
    -6.58
    (0.14)
    -6.50
    (0.14)
    -6.56
    (0.14)
    -6.36
    (0.15)
    -6.69
    (0.14)
    -6.60
    (0.13)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Pooled Placebo (IV + SC), 300mg IV
    Comments Difference vs. Placebo, by Day 3 (log10 copies/mL)
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0070
    Comments
    Method Mixed Model for Repeated Measures (MMRM)
    Comments
    Method of Estimation Estimation Parameter Difference of LS Means
    Estimated Value -0.49
    Confidence Interval () 95%
    -0.85 to -0.14
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.18
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Pooled Placebo (IV + SC), 600mg IV
    Comments Difference vs. Placebo, by Day 3 (log10 copies/mL)
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0002
    Comments
    Method Mixed Model for Repeated Measures (MMRM)
    Comments
    Method of Estimation Estimation Parameter Difference of LS Means
    Estimated Value -0.69
    Confidence Interval (2-Sided) 95%
    -1.06 to -0.33
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.19
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Pooled Placebo (IV + SC), 1200mg IV
    Comments Difference vs. Placebo, by Day 3 (log10 copies/mL)
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0008
    Comments
    Method Mixed Model for Repeated Measures (MMRM)
    Comments
    Method of Estimation Estimation Parameter Difference of LS Means
    Estimated Value -0.63
    Confidence Interval () 95%
    -1.00 to -0.26
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.19
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Pooled Placebo (IV + SC), 2400mg IV
    Comments Difference vs. Placebo, by Day 3 (log10 copies/mL)
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0125
    Comments
    Method Mixed Model for Repeated Measures (MMRM)
    Comments
    Method of Estimation Estimation Parameter Difference of LS Means
    Estimated Value -0.48
    Confidence Interval () 95%
    -0.85 to -0.10
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.19
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Pooled Placebo (IV + SC), 600mg SC
    Comments Difference vs. Placebo, by Day 3 (log10 copies/mL)
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0696
    Comments
    Method Mixed Model for Repeated Measures (MMRM)
    Comments
    Method of Estimation Estimation Parameter Difference of LS Means
    Estimated Value -0.34
    Confidence Interval () 95%
    -0.70 to 0.03
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.18
    Estimation Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Pooled Placebo (IV + SC), 1200mg SC
    Comments Difference vs. Placebo, by Day 3 (log10 copies/mL)
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0187
    Comments
    Method Mixed Model for Repeated Measures (MMRM)
    Comments
    Method of Estimation Estimation Parameter Difference of LS Means
    Estimated Value -0.43
    Confidence Interval (2-Sided) 95%
    -0.79 to -0.07
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.18
    Estimation Comments
    Statistical Analysis 7
    Statistical Analysis Overview Comparison Group Selection Pooled Placebo (IV + SC), 300mg IV
    Comments Difference vs. Placebo, by Day 5 (log10 copies/mL)
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments
    Method Mixed Model for Repeated Measures (MMRM)
    Comments
    Method of Estimation Estimation Parameter Difference of LS Means
    Estimated Value -0.96
    Confidence Interval () 95%
    -1.39 to -0.52
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.22
    Estimation Comments
    Statistical Analysis 8
    Statistical Analysis Overview Comparison Group Selection Pooled Placebo (IV + SC), 600mg IV
    Comments Difference vs. Placebo, by Day 5 (log10 copies/mL)
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments
    Method Mixed Model for Repeated Measures (MMRM)
    Comments
    Method of Estimation Estimation Parameter Difference of LS Means
    Estimated Value -1.09
    Confidence Interval () 95%
    -1.53 to -0.64
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.23
    Estimation Comments
    Statistical Analysis 9
    Statistical Analysis Overview Comparison Group Selection Pooled Placebo (IV + SC), 1200mg IV
    Comments Difference vs. Placebo, by Day 5 (log10 copies/mL)
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments
    Method Mixed Model for Repeated Measures (MMRM)
    Comments
    Method of Estimation Estimation Parameter Difference of LS Means
    Estimated Value -1.03
    Confidence Interval () 95%
    -1.48 to -0.59
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.23
    Estimation Comments
    Statistical Analysis 10
    Statistical Analysis Overview Comparison Group Selection Pooled Placebo (IV + SC), 2400mg IV
    Comments Difference vs. Placebo, by Day 5 (log10 copies/mL)
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments
    Method Mixed Model for Repeated Measures (MMRM)
    Comments
    Method of Estimation Estimation Parameter Difference of LS Means
    Estimated Value -1.05
    Confidence Interval () 95%
    -1.50 to -0.60
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.23
    Estimation Comments
    Statistical Analysis 11
    Statistical Analysis Overview Comparison Group Selection Pooled Placebo (IV + SC), 600mg SC
    Comments Difference vs. Placebo, by Day 5 (log10 copies/mL)
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments
    Method Mixed Model for Repeated Measures (MMRM)
    Comments
    Method of Estimation Estimation Parameter Difference of LS Means
    Estimated Value -0.90
    Confidence Interval (2-Sided) 95%
    -1.34 to -0.46
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.22
    Estimation Comments
    Statistical Analysis 12
    Statistical Analysis Overview Comparison Group Selection Pooled Placebo (IV + SC), 1200mg SC
    Comments Difference vs. Placebo, by Day 5 (log10 copies/mL)
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments
    Method Mixed Model for Repeated Measures (MMRM)
    Comments
    Method of Estimation Estimation Parameter Difference of LS Means
    Estimated Value -0.92
    Confidence Interval () 95%
    -1.35 to -0.48
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.22
    Estimation Comments
    Statistical Analysis 13
    Statistical Analysis Overview Comparison Group Selection Pooled Placebo (IV + SC), 300mg IV
    Comments Difference vs. Placebo, by Day 7 (log10 copies/mL)
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0004
    Comments
    Method Mixed Model for Repeated Measures (MMRM)
    Comments
    Method of Estimation Estimation Parameter Difference of LS Means
    Estimated Value -0.79
    Confidence Interval () 95%
    -1.23 to -0.35
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.22
    Estimation Comments
    Statistical Analysis 14
    Statistical Analysis Overview Comparison Group Selection Pooled Placebo (IV + SC), 600mg IV
    Comments Difference vs. Placebo, by Day 7 (log10 copies/mL)
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0058
    Comments
    Method Mixed Model for Repeated Measures (MMRM)
    Comments
    Method of Estimation Estimation Parameter Difference of LS Means
    Estimated Value -0.63
    Confidence Interval () 95%
    -1.08 to -0.18
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.23
    Estimation Comments
    Statistical Analysis 15
    Statistical Analysis Overview Comparison Group Selection Pooled Placebo (IV + SC), 1200mg IV
    Comments Difference vs. Placebo, by Day 7 (log10 copies/mL)
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0046
    Comments
    Method Mixed Model for Repeated Measures (MMRM)
    Comments
    Method of Estimation Estimation Parameter Difference of LS Means
    Estimated Value -0.66
    Confidence Interval () 95%
    -1.11 to -0.20
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.23
    Estimation Comments
    Statistical Analysis 16
    Statistical Analysis Overview Comparison Group Selection Pooled Placebo (IV + SC), 2400mg IV
    Comments Difference vs. Placebo, by Day 7 (log10 copies/mL)
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0019
    Comments
    Method Mixed Model for Repeated Measures (MMRM)
    Comments
    Method of Estimation Estimation Parameter Difference of LS Means
    Estimated Value -0.73
    Confidence Interval () 95%
    -1.18 to -0.27
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.23
    Estimation Comments
    Statistical Analysis 17
    Statistical Analysis Overview Comparison Group Selection Pooled Placebo (IV + SC), 600mg SC
    Comments Difference vs. Placebo, by Day 7 (log10 copies/mL)
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments
    Method Mixed Model for Repeated Measures (MMRM)
    Comments
    Method of Estimation Estimation Parameter Difference of LS Means
    Estimated Value -0.89
    Confidence Interval () 95%
    -1.33 to -0.44
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.23
    Estimation Comments
    Statistical Analysis 18
    Statistical Analysis Overview Comparison Group Selection Pooled Placebo (IV + SC), 1200mg SC
    Comments Difference vs. Placebo, by Day 7 (log10 copies/mL)
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0079
    Comments
    Method Mixed Model for Repeated Measures (MMRM)
    Comments
    Method of Estimation Estimation Parameter Difference of LS Means
    Estimated Value -0.60
    Confidence Interval () 95%
    -1.04 to -0.16
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.22
    Estimation Comments
    Statistical Analysis 19
    Statistical Analysis Overview Comparison Group Selection Pooled Placebo (IV + SC), 300mg IV
    Comments Difference vs. Placebo, by Day 15 (log10 copies/mL)
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0515
    Comments
    Method Mixed Model for Repeated Measures (MMRM)
    Comments
    Method of Estimation Estimation Parameter Difference of LS Means
    Estimated Value -0.45
    Confidence Interval () 95%
    -0.90 to 0.00
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.23
    Estimation Comments
    Statistical Analysis 20
    Statistical Analysis Overview Comparison Group Selection Pooled Placebo (IV + SC), 600mg IV
    Comments Difference vs. Placebo, by Day 15 (log10 copies/mL)
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1864
    Comments
    Method Mixed Model for Repeated Measures (MMRM)
    Comments
    Method of Estimation Estimation Parameter Difference of LS Means
    Estimated Value -0.31
    Confidence Interval () 95%
    -0.77 to 0.15
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.23
    Estimation Comments
    Statistical Analysis 21
    Statistical Analysis Overview Comparison Group Selection Pooled Placebo (IV + SC), 1200mg IV
    Comments Difference vs. Placebo, by Day 15 (log10 copies/mL)
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.2866
    Comments
    Method Mixed Model for Repeated Measures (MMRM)
    Comments
    Method of Estimation Estimation Parameter Difference of LS Means
    Estimated Value -0.25
    Confidence Interval () 95%
    -0.72 to 0.21
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.24
    Estimation Comments
    Statistical Analysis 22
    Statistical Analysis Overview Comparison Group Selection Pooled Placebo (IV + SC), 2400mg IV
    Comments Difference vs. Placebo, by Day 15 (log10 copies/mL)
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.6470
    Comments
    Method Mixed Model for Repeated Measures (MMRM)
    Comments
    Method of Estimation Estimation Parameter Difference of LS Means
    Estimated Value -0.11
    Confidence Interval () 95%
    -0.58 to 0.36
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.24
    Estimation Comments
    Statistical Analysis 23
    Statistical Analysis Overview Comparison Group Selection Pooled Placebo (IV + SC), 600mg SC
    Comments Difference vs. Placebo, by Day 15 (log10 copies/mL)
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0280
    Comments
    Method Mixed Model for Repeated Measures (MMRM)
    Comments
    Method of Estimation Estimation Parameter Difference of LS Means
    Estimated Value -0.51
    Confidence Interval () 95%
    -0.97 to -0.06
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.23
    Estimation Comments
    Statistical Analysis 24
    Statistical Analysis Overview Comparison Group Selection Pooled Placebo (IV + SC), 1200mg SC
    Comments Difference vs. Placebo, by Day 15 (log10 copies/mL)
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0854
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Difference of LS Means
    Estimated Value -0.39
    Confidence Interval () 95%
    -0.84 to 0.05
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.23
    Estimation Comments
    Statistical Analysis 25
    Statistical Analysis Overview Comparison Group Selection Pooled Placebo (IV + SC), 300mg IV
    Comments Difference vs. Placebo, by Day 22 (log10 copies/mL)
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1078
    Comments
    Method Mixed Model for Repeated Measures (MMRM)
    Comments
    Method of Estimation Estimation Parameter Difference of LS Means
    Estimated Value -0.31
    Confidence Interval (2-Sided) 95%
    -0.69 to 0.07
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.19
    Estimation Comments
    Statistical Analysis 26
    Statistical Analysis Overview Comparison Group Selection Pooled Placebo (IV + SC), 600mg IV
    Comments Difference vs. Placebo, by Day 22 (log10 copies/mL)
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.2235
    Comments
    Method Mixed Model for Repeated Measures (MMRM)
    Comments
    Method of Estimation Estimation Parameter Difference of LS Means
    Estimated Value -0.24
    Confidence Interval () 95%
    -0.62 to 0.14
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.19
    Estimation Comments
    Statistical Analysis 27
    Statistical Analysis Overview Comparison Group Selection Pooled Placebo (IV + SC), 1200mg IV
    Comments Difference vs. Placebo, by Day 22 (log10 copies/mL)
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1369
    Comments
    Method Mixed Model for Repeated Measures (MMRM)
    Comments
    Method of Estimation Estimation Parameter Difference of LS Means
    Estimated Value -0.29
    Confidence Interval () 95%
    -0.68 to 0.09
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.20
    Estimation Comments
    Statistical Analysis 28
    Statistical Analysis Overview Comparison Group Selection Pooled Placebo (IV + SC), 2400mg IV
    Comments Difference vs. Placebo, by Day 22 (log10 copies/mL)
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.6610
    Comments
    Method Mixed Model for Repeated Measures (MMRM)
    Comments
    Method of Estimation Estimation Parameter Difference of LS Means
    Estimated Value -0.09
    Confidence Interval () 95%
    -0.48 to 0.31
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.20
    Estimation Comments
    Statistical Analysis 29
    Statistical Analysis Overview Comparison Group Selection Pooled Placebo (IV + SC), 600mg SC
    Comments Difference vs. Placebo, by Day 22 (log10 copies/mL)
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0284
    Comments
    Method Mixed Model for Repeated Measures (MMRM)
    Comments
    Method of Estimation Estimation Parameter Difference of LS Means
    Estimated Value -0.43
    Confidence Interval () 95%
    -0.81 to -0.05
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.19
    Estimation Comments
    Statistical Analysis 30
    Statistical Analysis Overview Comparison Group Selection Pooled Placebo (IV + SC), 1200mg SC
    Comments Difference vs. Placebo, by Day 22 (log10 copies/mL)
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0800
    Comments
    Method Mixed Model for Repeated Measures (MMRM)
    Comments
    Method of Estimation Estimation Parameter Difference of LS Means
    Estimated Value -0.33
    Confidence Interval () 95%
    -0.71 to 0.04
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.19
    Estimation Comments
    9. Secondary Outcome
    Title Number of Participants With Treatment-Emergent Serious Adverse Events (SAEs)
    Description
    Time Frame Through day 29

    Outcome Measure Data

    Analysis Population Description
    Safety Analysis Set (SAF): Randomized participants who received any study drug; based on the treatment received (as treated)
    Arm/Group Title Placebo IV Dose 300mg IV 600mg IV 1200mg IV 2400mg IV Placebo SC Dose 600mg SC 1200mg SC
    Arm/Group Description Participants received a single intravenous dose of placebo matching REGN10933+REGN10987 Participants received a single 300mg intravenous dose of REGN10933+REGN10987 Participants received a single 600mg intravenous dose of REGN10933+REGN10987 Participants received a single 1200mg intravenous dose of REGN10933+REGN10987 Participants received a single 2400mg intravenous dose of REGN10933+REGN10987 Participants received a single subcutaneous dose of placebo matching REGN10933+REGN10987 Participants received a single 600mg subcutaneous dose of REGN10933+REGN10987 Participants received a single 1200mg subcutaneous dose of REGN10933+REGN10987
    Measure Participants 82 165 162 165 166 82 163 164
    Count of Participants [Participants]
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    2
    1.2%
    0
    0%
    0
    0%
    1
    0.6%
    10. Secondary Outcome
    Title Number of Participants With Infusion-Related Reactions Grade 2 or Above
    Description
    Time Frame Through day 4

    Outcome Measure Data

    Analysis Population Description
    Safety Analysis Set (SAF): Randomized participants who received any study drug; based on the treatment received (as treated)
    Arm/Group Title Placebo IV Dose 300mg IV 600mg IV 1200mg IV 2400mg IV Placebo SC Dose 600mg SC 1200mg SC
    Arm/Group Description Participants received a single intravenous dose of placebo matching REGN10933+REGN10987 Participants received a single 300mg intravenous dose of REGN10933+REGN10987 Participants received a single 600mg intravenous dose of REGN10933+REGN10987 Participants received a single 1200mg intravenous dose of REGN10933+REGN10987 Participants received a single 2400mg intravenous dose of REGN10933+REGN10987 Participants received a single subcutaneous dose of placebo matching REGN10933+REGN10987 Participants received a single 600mg subcutaneous dose of REGN10933+REGN10987 Participants received a single 1200mg subcutaneous dose of REGN10933+REGN10987
    Measure Participants 82 165 162 165 166 82 163 164
    Count of Participants [Participants]
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    11. Secondary Outcome
    Title Number of Participants With Injection-Site Reactions Grade 3 or Above
    Description
    Time Frame Through day 4

    Outcome Measure Data

    Analysis Population Description
    Safety Analysis Set (SAF): Randomized participants who received any study drug; based on the treatment received (as treated)
    Arm/Group Title Placebo IV Dose 300mg IV 600mg IV 1200mg IV 2400mg IV Placebo SC Dose 600mg SC 1200mg SC
    Arm/Group Description Participants received a single intravenous dose of placebo matching REGN10933+REGN10987 Participants received a single 300mg intravenous dose of REGN10933+REGN10987 Participants received a single 600mg intravenous dose of REGN10933+REGN10987 Participants received a single 1200mg intravenous dose of REGN10933+REGN10987 Participants received a single 2400mg intravenous dose of REGN10933+REGN10987 Participants received a single subcutaneous dose of placebo matching REGN10933+REGN10987 Participants received a single 600mg subcutaneous dose of REGN10933+REGN10987 Participants received a single 1200mg subcutaneous dose of REGN10933+REGN10987
    Measure Participants 82 165 162 165 166 82 163 164
    Count of Participants [Participants]
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    12. Secondary Outcome
    Title Number of Participants With Hypersensitivity Reactions Grade 2 or Above
    Description
    Time Frame Through day 29

    Outcome Measure Data

    Analysis Population Description
    Safety Analysis Set (SAF): Randomized participants who received any study drug; based on the treatment received (as treated)
    Arm/Group Title Placebo IV Dose 300mg IV 600mg IV 1200mg IV 2400mg IV Placebo SC Dose 600mg SC 1200mg SC
    Arm/Group Description Participants received a single intravenous dose of placebo matching REGN10933+REGN10987 Participants received a single 300mg intravenous dose of REGN10933+REGN10987 Participants received a single 600mg intravenous dose of REGN10933+REGN10987 Participants received a single 1200mg intravenous dose of REGN10933+REGN10987 Participants received a single 2400mg intravenous dose of REGN10933+REGN10987 Participants received a single subcutaneous dose of placebo matching REGN10933+REGN10987 Participants received a single 600mg subcutaneous dose of REGN10933+REGN10987 Participants received a single 1200mg subcutaneous dose of REGN10933+REGN10987
    Measure Participants 82 165 162 165 166 82 163 164
    Count of Participants [Participants]
    0
    0%
    0
    0%
    1
    0.6%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    1
    0.6%
    13. Secondary Outcome
    Title Concentration of REGN10933 in Serum
    Description
    Time Frame Pre-Dose, 15 minutes Post-Dose, 3 days Post-Dose, 5 days Post-Dose, 7 days Post-Dose, 120 days Post-Dose

    Outcome Measure Data

    Analysis Population Description
    Number Analyzed = number of participants contributing to each nominal timepoint
    Arm/Group Title 300mg IV 600mg IV 1200mg IV 2400mg IV 600mg SC 1200mg SC
    Arm/Group Description Participants received a single 300mg intravenous dose of REGN10933+REGN10987 Participants received a single 600mg intravenous dose of REGN10933+REGN10987 Participants received a single 1200mg intravenous dose of REGN10933+REGN10987 Participants received a single 2400mg intravenous dose of REGN10933+REGN10987 Participants received a single 600mg subcutaneous dose of REGN10933+REGN10987 Participants received a single 1200mg subcutaneous dose of REGN10933+REGN10987
    Measure Participants 165 162 165 166 163 164
    Pre-dose
    0.529
    (4.51)
    1.95
    (12.1)
    0.847
    (6.28)
    13.3
    (130)
    0.992
    (12.5)
    0.395
    (4.96)
    15 minutes Post-Dose
    58.2
    (52.1)
    95.8
    (57.9)
    178
    (118)
    375
    (267)
    8.73
    (52.7)
    3.89
    (19.7)
    3 days Post-Dose
    32.5
    (15.7)
    54.9
    (19.2)
    109
    (37.9)
    223
    (63.9)
    22.4
    (18.3)
    41.0
    (19.3)
    5 days Post-Dose
    27.7
    (16.8)
    46.6
    (16.9)
    88.4
    (27.8)
    186
    (53.3)
    26.3
    (10.7)
    54.9
    (34.0)
    7 days Post-Dose
    23.9
    (13.5)
    39.8
    (11.5)
    82.8
    (26.3)
    164
    (46.0)
    26.8
    (9.65)
    54.6
    (19.9)
    120 days Post-Dose
    1.78
    (1.13)
    3.25
    (1.88)
    6.46
    (4.74)
    12.3
    (8.42)
    2.73
    (1.89)
    5.64
    (3.77)
    14. Secondary Outcome
    Title Immunogenicity as Measured by Anti-drug Antibodies (ADAs) to REGN10933
    Description
    Time Frame Through day 120

    Outcome Measure Data

    Analysis Population Description
    ADA analysis set includes all treated participants who received any amount of study drug and had at least one non-missing antibody variables result following the first dose of study drug or placebo.
    Arm/Group Title Pooled Placebo (IV + SC) 300mg IV 600mg IV 1200mg IV 2400mg IV 600mg SC 1200mg SC
    Arm/Group Description Participants received a single intravenous dose of placebo matching REGN10933+REGN10987 or a single subcutaneous dose of placebo matching REGN10933+REGN10987 Participants received a single 300mg intravenous dose of REGN10933+REGN10987 Participants received a single 600mg intravenous dose of REGN10933+REGN10987 Participants received a single 1200mg intravenous dose of REGN10933+REGN10987 Participants received a single 2400mg intravenous dose of REGN10933+REGN10987 Participants received a single 600mg subcutaneous dose of REGN10933+REGN10987 Participants received a single 1200mg subcutaneous dose of REGN10933+REGN10987
    Measure Participants 149 152 138 150 150 147 141
    Pre-existing Immunoreactivity
    3
    3.7%
    2
    1.2%
    3
    1.9%
    0
    0%
    2
    1.2%
    1
    1.2%
    3
    1.8%
    Treatment-Boosted Response
    0
    0%
    0
    0%
    1
    0.6%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Treatment-Emergent Response
    4
    4.9%
    11
    6.7%
    6
    3.7%
    7
    4.2%
    1
    0.6%
    14
    17.1%
    5
    3.1%
    Negative
    142
    173.2%
    139
    84.2%
    128
    79%
    143
    86.7%
    147
    88.6%
    132
    161%
    133
    81.6%
    15. Secondary Outcome
    Title Immunogenicity as Measured by Neutralizing Anti-drug Antibody (NAb) to REGN10933
    Description
    Time Frame Through day 120

    Outcome Measure Data

    Analysis Population Description
    NAb analysis set includes all treated participants who received any study drug, had at least one non-missing antibody result following the first dose of study drug, and either tested negative at all ADA sampling times or tested positive for ADA with at least one non-missing NAb result after first dose of the study drug.
    Arm/Group Title Pooled Placebo (IV + SC) 300mg IV 600mg IV 1200mg IV 2400mg IV 600mg SC 1200mg SC
    Arm/Group Description Participants received a single intravenous dose of placebo matching REGN10933+REGN10987 or a single subcutaneous dose of placebo matching REGN10933+REGN10987 Participants received a single 300mg intravenous dose of REGN10933+REGN10987 Participants received a single 600mg intravenous dose of REGN10933+REGN10987 Participants received a single 1200mg intravenous dose of REGN10933+REGN10987 Participants received a single 2400mg intravenous dose of REGN10933+REGN10987 Participants received a single 600mg subcutaneous dose of REGN10933+REGN10987 Participants received a single 1200mg subcutaneous dose of REGN10933+REGN10987
    Measure Participants 148 152 138 150 150 147 141
    Treatment-emergent & Treatment-boosted; Negative in NAb assay
    4
    4.9%
    11
    6.7%
    7
    4.3%
    6
    3.6%
    0
    0%
    13
    15.9%
    5
    3.1%
    Treatment-emergent & Treatment-boosted; Positive in NAb assay
    0
    0%
    0
    0%
    0
    0%
    1
    0.6%
    1
    0.6%
    1
    1.2%
    0
    0%
    ADA Negative
    142
    173.2%
    139
    84.2%
    128
    79%
    143
    86.7%
    147
    88.6%
    132
    161%
    133
    81.6%
    16. Secondary Outcome
    Title Concentration of REGN10987 in Serum
    Description
    Time Frame Pre-Dose, 15 minutes Post-Dose, 3 days Post-Dose, 5 days Post-Dose, 7 days Post-Dose, 120 days Post-Dose

    Outcome Measure Data

    Analysis Population Description
    Number Analyzed = number of participants contributing to each nominal timepoint
    Arm/Group Title 300mg IV 600mg IV 1200mg IV 2400mg IV 600mg SC 1200mg SC
    Arm/Group Description Participants received a single 300mg intravenous dose of REGN10933+REGN10987 Participants received a single 600mg intravenous dose of REGN10933+REGN10987 Participants received a single 1200mg intravenous dose of REGN10933+REGN10987 Participants received a single 2400mg intravenous dose of REGN10933+REGN10987 Participants received a single 600mg subcutaneous dose of REGN10933+REGN10987 Participants received a single 1200mg subcutaneous dose of REGN10933+REGN10987
    Measure Participants 165 162 165 166 163 164
    Pre-dose
    0.529
    (4.38)
    2.04
    (12.7)
    0.823
    (6.48)
    13.1
    (126)
    1.02
    (12.8)
    0.370
    (4.64)
    15 minutes Post-Dose
    56.9
    (53.1)
    95.4
    (59.4)
    178
    (119)
    383
    (273)
    8.48
    (51.7)
    4.36
    (21.6)
    3 days Post-Dose
    32.6
    (15.9)
    56.0
    (18.9)
    109
    (38.5)
    225
    (62.3)
    21.8
    (16.2)
    42.0
    (20.1)
    5 days Post-Dose
    26.6
    (15.5)
    46.3
    (15.9)
    87.1
    (26.9)
    177
    (50.9)
    25.6
    (9.31)
    52.9
    (29.1)
    7 days Post-Dose
    22.8
    (12.8)
    38.0
    (11.2)
    77.7
    (24.3)
    151
    (43.1)
    26.2
    (8.74)
    53.7
    (17.9)
    120 days Post-Dose
    1.02
    (0.805)
    1.97
    (1.38)
    3.80
    (3.10)
    6.88
    (5.47)
    1.63
    (1.43)
    3.26
    (2.49)
    17. Secondary Outcome
    Title Immunogenicity as Measured by Anti-drug Antibodies (ADAs) to REGN10987
    Description
    Time Frame Through day 120

    Outcome Measure Data

    Analysis Population Description
    ADA analysis set includes all treated participants who received any amount of study drug and had at least one non-missing antibody variables result following the first dose of study drug or placebo.
    Arm/Group Title Pooled Placebo (IV + SC) 300mg IV 600mg IV 1200mg IV 2400mg IV 600mg SC 1200mg SC
    Arm/Group Description Participants received a single intravenous dose of placebo matching REGN10933+REGN10987 or a single subcutaneous dose of placebo matching REGN10933+REGN10987 Participants received a single 300mg intravenous dose of REGN10933+REGN10987 Participants received a single 600mg intravenous dose of REGN10933+REGN10987 Participants received a single 1200mg intravenous dose of REGN10933+REGN10987 Participants received a single 2400mg intravenous dose of REGN10933+REGN10987 Participants received a single 600mg subcutaneous dose of REGN10933+REGN10987 Participants received a single 1200mg subcutaneous dose of REGN10933+REGN10987
    Measure Participants 149 152 138 150 150 147 141
    Pre-existing Immunoreactivity
    3
    3.7%
    4
    2.4%
    0
    0%
    3
    1.8%
    3
    1.8%
    3
    3.7%
    3
    1.8%
    Treatment-Boosted Response
    0
    0%
    0
    0%
    1
    0.6%
    1
    0.6%
    0
    0%
    0
    0%
    0
    0%
    Treatment-Emergent Response
    6
    7.3%
    17
    10.3%
    11
    6.8%
    13
    7.9%
    7
    4.2%
    23
    28%
    14
    8.6%
    Negative
    142
    173.2%
    131
    79.4%
    126
    77.8%
    133
    80.6%
    140
    84.3%
    121
    147.6%
    124
    76.1%
    18. Secondary Outcome
    Title Immunogenicity as Measured by Neutralizing Anti-drug Antibody (NAb) to REGN10987
    Description
    Time Frame Through day 120

    Outcome Measure Data

    Analysis Population Description
    NAb analysis set includes all treated participants who received any study drug, had at least one non-missing antibody result following the first dose of study drug, and either tested negative at all ADA sampling times or tested positive for ADA with at least one non-missing NAb result after first dose of the study drug.
    Arm/Group Title Pooled Placebo (IV + SC) 300mg IV 600mg IV 1200mg IV 2400mg IV 600mg SC 1200mg SC
    Arm/Group Description Participants received a single intravenous dose of placebo matching REGN10933+REGN10987 or a single subcutaneous dose of placebo matching REGN10933+REGN10987 Participants received a single 300mg intravenous dose of REGN10933+REGN10987 Participants received a single 600mg intravenous dose of REGN10933+REGN10987 Participants received a single 1200mg intravenous dose of REGN10933+REGN10987 Participants received a single 2400mg intravenous dose of REGN10933+REGN10987 Participants received a single 600mg subcutaneous dose of REGN10933+REGN10987 Participants received a single 1200mg subcutaneous dose of REGN10933+REGN10987
    Measure Participants 148 152 138 150 150 147 141
    Pre-existing Immunoreactivity; Negative in NAb assay
    1
    1.2%
    2
    1.2%
    0
    0%
    2
    1.2%
    1
    0.6%
    2
    2.4%
    3
    1.8%
    Treatment-emergent & Treatment-boosted; Negative in NAb assay
    5
    6.1%
    10
    6.1%
    7
    4.3%
    10
    6.1%
    5
    3%
    17
    20.7%
    10
    6.1%
    Treatment-emergent & Treatment-boosted; Positive in NAb assay
    1
    1.2%
    7
    4.2%
    5
    3.1%
    4
    2.4%
    2
    1.2%
    6
    7.3%
    4
    2.5%
    ADA Negative
    140
    170.7%
    131
    79.4%
    126
    77.8%
    133
    80.6%
    140
    84.3%
    121
    147.6%
    124
    76.1%

    Adverse Events

    Time Frame From first dose of study drug to Day 169
    Adverse Event Reporting Description
    Arm/Group Title Placebo IV REGN10933 + REGN10987 300 mg IV REGN10933 + REGN10987 600 mg IV REGN10933 + REGN10987 1200 mg IV REGN10933 + REGN10987 2400 mg IV Placebo SC REGN10933 + REGN10987 600 mg SC REGN10933 + REGN10987 1200 mg SC
    Arm/Group Description Participants received a single intravenous dose of placebo matching REGN10933+REGN10987 Participants received a single 300mg intravenous dose of REGN10933+REGN10987 Participants received a single 600mg intravenous dose of REGN10933+REGN10987 Participants received a single 1200mg intravenous dose of REGN10933+REGN10987 Participants received a single 2400mg intravenous dose of REGN10933+REGN10987 Participants received a single subcutaneous dose of placebo matching REGN10933+REGN10987 Participants received a single 600mg subcutaneous dose of REGN10933+REGN10987 Participants received a single 1200mg subcutaneous dose of REGN10933+REGN10987
    All Cause Mortality
    Placebo IV REGN10933 + REGN10987 300 mg IV REGN10933 + REGN10987 600 mg IV REGN10933 + REGN10987 1200 mg IV REGN10933 + REGN10987 2400 mg IV Placebo SC REGN10933 + REGN10987 600 mg SC REGN10933 + REGN10987 1200 mg SC
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/82 (0%) 0/165 (0%) 0/162 (0%) 0/165 (0%) 0/166 (0%) 0/82 (0%) 0/163 (0%) 0/164 (0%)
    Serious Adverse Events
    Placebo IV REGN10933 + REGN10987 300 mg IV REGN10933 + REGN10987 600 mg IV REGN10933 + REGN10987 1200 mg IV REGN10933 + REGN10987 2400 mg IV Placebo SC REGN10933 + REGN10987 600 mg SC REGN10933 + REGN10987 1200 mg SC
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 1/82 (1.2%) 1/165 (0.6%) 0/162 (0%) 1/165 (0.6%) 3/166 (1.8%) 0/82 (0%) 0/163 (0%) 1/164 (0.6%)
    Infections and infestations
    COVID-19 pneumonia 0/82 (0%) 0 0/165 (0%) 0 0/162 (0%) 0 0/165 (0%) 0 0/166 (0%) 0 0/82 (0%) 0 0/163 (0%) 0 1/164 (0.6%) 1
    Injury, poisoning and procedural complications
    Face injury 0/82 (0%) 0 1/165 (0.6%) 1 0/162 (0%) 0 0/165 (0%) 0 0/166 (0%) 0 0/82 (0%) 0 0/163 (0%) 0 0/164 (0%) 0
    Abdominal injury 0/82 (0%) 0 0/165 (0%) 0 0/162 (0%) 0 0/165 (0%) 0 1/166 (0.6%) 1 0/82 (0%) 0 0/163 (0%) 0 0/164 (0%) 0
    Road traffic accident 0/82 (0%) 0 0/165 (0%) 0 0/162 (0%) 0 0/165 (0%) 0 1/166 (0.6%) 1 0/82 (0%) 0 0/163 (0%) 0 0/164 (0%) 0
    Metabolism and nutrition disorders
    Diabetic ketoacidosis 0/82 (0%) 0 0/165 (0%) 0 0/162 (0%) 0 0/165 (0%) 0 1/166 (0.6%) 1 0/82 (0%) 0 0/163 (0%) 0 0/164 (0%) 0
    Pregnancy, puerperium and perinatal conditions
    Abortion spontaneous 0/82 (0%) 0 0/165 (0%) 0 0/162 (0%) 0 1/165 (0.6%) 1 1/166 (0.6%) 1 0/82 (0%) 0 0/163 (0%) 0 0/164 (0%) 0
    Psychiatric disorders
    Mental status changes 1/82 (1.2%) 1 0/165 (0%) 0 0/162 (0%) 0 0/165 (0%) 0 0/166 (0%) 0 0/82 (0%) 0 0/163 (0%) 0 0/164 (0%) 0
    Renal and urinary disorders
    Urinary bladder rupture 0/82 (0%) 0 0/165 (0%) 0 0/162 (0%) 0 0/165 (0%) 0 1/166 (0.6%) 1 0/82 (0%) 0 0/163 (0%) 0 0/164 (0%) 0
    Other (Not Including Serious) Adverse Events
    Placebo IV REGN10933 + REGN10987 300 mg IV REGN10933 + REGN10987 600 mg IV REGN10933 + REGN10987 1200 mg IV REGN10933 + REGN10987 2400 mg IV Placebo SC REGN10933 + REGN10987 600 mg SC REGN10933 + REGN10987 1200 mg SC
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 17/82 (20.7%) 21/165 (12.7%) 27/162 (16.7%) 28/165 (17%) 16/166 (9.6%) 11/82 (13.4%) 18/163 (11%) 21/164 (12.8%)
    Infections and infestations
    COVID-19 17/82 (20.7%) 18 21/165 (12.7%) 21 27/162 (16.7%) 28 28/165 (17%) 29 16/166 (9.6%) 18 11/82 (13.4%) 11 18/163 (11%) 19 21/164 (12.8%) 21

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    The investigator has the right to independently publish study results from the investigator's site after a multi-center publication, or a defined period after the completion of the study by all sites. The investigator must provide the sponsor a copy of any such publication derived from the study for review and comment in advance of any submission, and delay publication, if requested, to allow the Sponsor to preserve its proprietary rights.

    Results Point of Contact

    Name/Title Clinical Trials Administrator
    Organization Regeneron Pharmaceuticals, Inc.
    Phone 844-734-6643
    Email clinicaltrials@regeneron.com
    Responsible Party:
    Regeneron Pharmaceuticals
    ClinicalTrials.gov Identifier:
    NCT04666441
    Other Study ID Numbers:
    • R10933-10987-COV-20145
    First Posted:
    Dec 14, 2020
    Last Update Posted:
    Apr 8, 2022
    Last Verified:
    Mar 1, 2022