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COVID-19 Study Assessing the Efficacy and Safety of Anti-Spike SARS CoV-2 Monoclonal Antibodies for Prevention of SARS CoV-2 Infection Asymptomatic in Healthy Adults and Adolescents Who Are Household Contacts to an Individual With a Positive SARS-CoV-2 RT-PCR Assay

Sponsor
Regeneron Pharmaceuticals (Industry)
Overall Status
Completed
CT.gov ID
NCT04452318
Collaborator
(none)
3,303
Enrollment
134
Locations
2
Arms
14.7
Actual Duration (Months)
24.6
Patients Per Site
1.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Primary Objectives:
Cohort A:

• To evaluate the efficacy of REGN10933+REGN10987 compared to placebo in preventing symptomatic SARS-CoV-2 infection (broad-term) confirmed by RT-qPCR

Cohort A and Cohort A1:

• To evaluate the safety and tolerability of REGN10933+REGN10987 following subcutaneous (SC) administration compared to placebo

Cohort B • To evaluate the efficacy of REGN10933+REGN10987 compared to placebo in preventing COVID-19 symptoms (broad-term)

Cohort B and Cohort B1

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

Condition or Disease Intervention/Treatment Phase
  • Drug: REGN10933 + REGN10987
  • Drug: Placebo
 Phase 3

Detailed Description

Cohort A: adult and adolescent subjects (≥12 years) who are SARS -CoV-2 RT-qPCR negative at baseline

Cohort A1: pediatric subjects (<12 years) who are SARS-CoV-2 RT--qPCR negative at baseline

Cohort B: adult and adolescent subjects (≥12 years) who are SARS -CoV-2 RT-qPCR positive at baseline

Cohort B1: pediatric subjects (<12 years) who are SARS-CoV-2 RT--qPCR positive at baseline

Study Design

Study Type:
Interventional
Actual Enrollment :
3303 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Assessing the Efficacy and Safety of Anti-Spike SARS-CoV-2 Monoclonal Antibodies in Preventing SARS-CoV-2 Infection in Household Contacts of Individuals Infected With SARS-CoV-2
Actual Study Start Date :
Jul 13, 2020
Actual Primary Completion Date :
Oct 4, 2021
Actual Study Completion Date :
Oct 4, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: REGN10933 + REGN10987

Drug: REGN10933 + REGN10987
Subcutaneous (SC) or Intramuscular (IM) injections
Other Names:
  • REGN-COV2
  • Casirivimab
  • Imdevimab
  • REGEN-COV™

    		•
    Placebo Comparator: Placebo

    Drug: Placebo
    SC or IM injections

    Outcome Measures

    Primary Outcome Measures

    1. Proportion of participants who have a symptomatic RT-qPCR confirmed SARS-CoV-2 infection (broad-term) during the EAP [Up to 1 month]

      For subjects who are seronegative at baseline (based on central lab test), unless stated otherwise. Cohort A

    2. Proportion of participants with treatment-emergent adverse events (TEAEs) and severity of TEAEs [Up to 8 months]

      For subjects who are seronegative at baseline (based on central lab test), unless stated otherwise. Cohort A and Cohort A1

    3. Proportion of participants who subsequently develop signs and symptoms (broad-term) within 14 days of a positive RT-qPCR at baseline or during the EAP [Up to 1 month]

      For all subject irrespective of baseline serology status (based on central lab test) Cohort B

    Secondary Outcome Measures

    1. Proportion of participants with a viral load >4 (log10 copies/mL) in Nasopharyngeal (NP) swab samples during the EAP [Up to 1 month]

      For subjects who are seronegative at baseline (based on central lab test), unless stated otherwise. Cohort A and Cohort A1 For all subjects irrespective of baseline serology status (based on central lab test) Cohort B and Cohort B1

    2. Number of weeks of symptomatic RT-qPCR confirmed SARS-CoV-2 infection (broad term) during the EAP [Up to 8 months]

      For subjects who are seronegative at baseline (based on central lab test), unless stated otherwise. Cohort A and Cohort A1

    3. Number of weeks of high viral load >4 (log10 copies/mL) in NP swab samples during the EAP [Up to 1 month]

      For subjects who are seronegative at baseline (based on central lab test), unless stated otherwise. Cohort A and Cohort A1 For all subjects irrespective of baseline serology status (based on central lab test) Cohort B and Cohort B1

    4. Number of weeks of RT-qPCR confirmed SARS-CoV-2 infection (regardless of symptoms) during the EAP [Up to 1 month]

      For subjects who are seronegative at baseline (based on central lab test), unless stated otherwise. Cohort A and Cohort A1

    5. Proportion of participants who have a RT-qPCR confirmed SARS-CoV-2 infection (regardless of symptoms) during the EAP [Up to 1 month]

      For subjects who are seronegative at baseline (based on central lab test), unless stated otherwise. Cohort A and Cohort A1

    6. Proportion of participants in placebo group with a RT-qPCR confirmed SARS-CoV-2 infection during the EAP with an index case participating in study R10933-10987-COV-2067 (NCT04425629) [Up to 1 month]

      For subjects who are seronegative at baseline (based on central lab test), unless stated otherwise. Cohort A and Cohort A1

    7. Proportion of participants who have a symptomatic RT-qPCR confirmed SARS-CoV-2 infection (CDC definition) during the EAP [Up to 1 month]

      For subjects who are seronegative at baseline (based on central lab test), unless stated otherwise. Cohort A and Cohort A1

    8. Number of weeks of symptomatic RT-qPCR-confirmed SARS-CoV-2 infection (CDC definition) during the EAP [Up to 1 month]

      For subjects who are seronegative at baseline (based on central lab test), unless stated otherwise. Cohort A and Cohort A1

    9. Proportion of participants who have a symptomatic RT-qPCR confirmed SARS-CoV-2 infection (strict-term) during the EAP [Up to 1 month]

      For subjects who are seronegative at baseline (based on central lab test), unless stated otherwise. Cohort A and Cohort A1

    10. Number of weeks of symptomatic RT-qPCR confirmed SARS-CoV-2 infection (strict-term) during the EAP [Up to 8 months]

      For subjects who are seronegative at baseline (based on central lab test), unless stated otherwise. Cohort A and Cohort A1

    11. Proportion of participants who have a RT-qPCR confirmed SARS-CoV-2 infections at each week in the EAP [Up to 1 month]

      For subjects who are seronegative at baseline (based on central lab test), unless stated otherwise. Cohort A and Cohort A1

    12. Proportion of participants who have a symptomatic RT-qPCR confirmed SARS-CoV-2 infection (broad-term) at each week in the EAP [Up to 1 month]

      For subjects who are seronegative at baseline (based on central lab test), unless stated otherwise. Cohort A and Cohort A1

    13. Time-weighted average of viral load (log10 copies/mL) from the first positive SARS CoV-2 RT-qPCR in NP swab samples (that has an onset during the EAP) until the third weekly visit after the first positive test during the EAP [Up to 1 month]

      For subjects who are seronegative at baseline (based on central lab test), unless stated otherwise. Cohort A and Cohort A1

    14. Time-weighted average of viral load (log10 copies/mL) from the first positive SARS-CoV-2 RT-qPCR in NP swab samples (that has an onset during the EAP) until the second weekly visit after the first positive test during the EAP [Up to 1 month]

      For subjects who are seronegative at baseline (based on central lab test), unless stated otherwise. Cohort A and Cohort A1

    15. Maximum SARS-CoV-2 RT-qPCR viral load (log10 copies/mL) in NP swab samples among individuals with ≥1 RT-qPCR positive that has an onset during the EAP [Up to1 month]

      For subjects who are seronegative at baseline (based on central lab test), unless stated otherwise. Cohort A and Cohort A1

    16. SARS-CoV-2 RT-qPCR viral load (log10 copies/mL) in NP swab samples corresponding to the onset of first positive RT-qPCR during the EAP [Up to 1 month]

      For subjects who are seronegative at baseline (based on central lab test), unless stated otherwise. Cohort A and Cohort A1

    17. Area under the curve (AUC) in viral load (log10 copies/mL) from the first positive SARS-CoV-2 RT-qPCR NP swab samples detected during the EAP until the first confirmed negative test [Up to 8 months]

      For subjects who are seronegative at baseline (based on central lab test), unless stated otherwise. Cohort A and Cohort A1

    18. Number of medically attended visits in emergency rooms or urgent care centers related to a RT-qPCR confirmed SARS-CoV-2 infection that has an onset during the EAP [Up to 8 months]

      For subjects who are seronegative at baseline (based on central lab test), unless stated otherwise. Cohort A and Cohort A1

    19. Proportion of participants with at least 1 COVID-19-related hospitalization or emergency room visit associated with a positive RT-qPCR during the EAP or all-cause death [Up to 8 months]

      For subjects who are seronegative at baseline (based on central lab test), unless stated otherwise. Cohort A and Cohort A1

    20. Proportion of participants requiring medically attended visits in emergency rooms or urgent care centers related to a RT-qPCR confirmed SARS CoV-2 infection that has an onset during the EAP [Up to 8 months]

      For subjects who are seronegative at baseline (based on central lab test), unless stated otherwise. Cohort A and Cohort A1

    21. Proportion of participants hospitalized related to a RT-qPCR confirmed SARS-CoV-2 infection that has an onset during the EAP [Up to 8 months]

      For subjects who are seronegative at baseline (based on central lab test), unless stated otherwise. Cohort A and Cohort A1

    22. Number of days of hospital and intensive care unit (ICU) stay in participants hospitalized for a RT-qPCR confirmed SARS-CoV-2 infection that has an onset during the EAP [Up to 8 months]

      For subjects who are seronegative at baseline (based on central lab test), unless stated otherwise. Cohort A and Cohort A1

    23. Number of days missed for daily responsibilities (where applicable) due to a RT-qPCR confirmed SARS-CoV-2 infection that has an onset during the EAP [Up to 8 months]

      Daily responsibilities including work (employed adults) or school (students), daycare or family obligations/responsibilities (childcare or eldercare) For subjects who are seronegative at baseline (based on central lab test), unless stated otherwise. Cohort A and Cohort A1

    24. Proportion of participants in the placebo group with a RT-qPCR confirmed SARS-CoV-2 infection during the EAP with at least 1 household member participating either in study R10933-10987-COV-2067 (NCT04425629) or in cohort B [Up to 1 month]

      For subjects who are seronegative at baseline (based on central lab test), unless stated otherwise. Cohort A and Cohort A1

    25. Proportion of subjects who have a symptomatic RT-qPCR confirmed SARS-CoV-2 infection (broad-term) during the EAP [Up to 1 month]

      For subjects who are seronegative at baseline (based on central lab test), unless stated otherwise. Cohort A1

    26. Proportion of baseline seropositive subjects (based on central lab test) with TEAEs and severity of TEAEs [Up to 8 months]

      For subjects who are seronegative at baseline (based on central lab test), unless stated otherwise. Cohort A and Cohort A1

    27. Incidence of symptomatic SARS-CoV-2 infection in seronegative and seropositive participants (based on central lab test) in both the EAP and follow-up periods [Up to 8 months]

      For subjects who are seronegative at baseline (based on central lab test), unless stated otherwise. Cohort A and Cohort A1

    28. Severity of symptomatic SARS-CoV-2 infection in seronegative and seropositive participants (based on central lab test) in both the EAP and follow-up periods [Up to 8 months]

      For subjects who are seronegative at baseline (based on central lab test), unless stated otherwise. Cohort A and Cohort A1

    29. Concentrations of REGN10933 in serum over time and selected PK parameters in seronegative and seropositive participants (based on central lab test) [Up to 8 months]

      Pharmacokinetic (PK) parameters may include, but are not limited to: Maximum observed plasma concentration (Cmax) Cmax/Dose Time of maximum observed plasma concentration (tmax) Time of Clast (tlast) Last measurable plasma concentration (Clast) Area under plasma concentration-time curve from time 0 to infinity (AUCinf) AUCinf/Dose Elimination half-life (t1/2) Concentration in serum 28 days (C28) after dosing) For subjects who are seronegative at baseline (based on central lab test), unless stated otherwise. Cohort A and Cohort A1 For all subjects irrespective of baseline serology status (based on central lab test) Cohort B and Cohort B1

    30. Concentrations of REGN10987 in serum over time and selected PK parameters in seronegative and seropositive participants (based on central lab test) [Up to 8 months]

      For subjects who are seronegative at baseline (based on central lab test), unless stated otherwise. Cohort A and Cohort A1 For all subjects irrespective of baseline serology status (based on central lab test) Cohort B and Cohort B1

    31. Immunogenicity as measured by anti-drug antibodies (ADA) to REGN10933 over time in seronegative and seropositive participants (based on central lab test) [Up to 8 months]

      For subjects who are seronegative at baseline (based on central lab test), unless stated otherwise. Cohort A and Cohort A1 For all subjects irrespective of baseline serology status (based on central lab test) Cohort B and Cohort B1

    32. Immunogenicity as measured by neutralizing anti-drug antibodies (NAbs) to REGN10933 over time in seronegative and seropositive participants (based on central lab test) [Up to 8 months]

      For subjects who are seronegative at baseline (based on central lab test), unless stated otherwise. Cohort A and Cohort A1 For all subjects irrespective of baseline serology status (based on central lab test) Cohort B and Cohort B1

    33. Immunogenicity as measured by anti-drug antibodies (ADA) to REGN10987 over time in seronegative and seropositive participants (based on central lab test) [Up to 8 months]

      For subjects who are seronegative at baseline (based on central lab test), unless stated otherwise. Cohort A and Cohort A1 For all subjects irrespective of baseline serology status (based on central lab test) Cohort B and Cohort B1

    34. Immunogenicity as measured by neutralizing anti-drug antibodies (NAbs) to REGN10987 over time in seronegative and seropositive participants (based on central lab test) [Up to 8 months]

      For subjects who are seronegative at baseline (based on central lab test), unless stated otherwise. Cohort A and Cohort A1 For all subjects irrespective of baseline serology status (based on central lab test) Cohort B and Cohort B1

    35. Number of weeks of symptomatic SARS-CoV-2 infection (broad-term) within 14 days of a positive RT-qPCR at baseline or during the EAP [Up to 8 months]

      For all subjects irrespective of baseline serology status (based on central lab test) Cohort B and Cohort B1

    36. Proportion of participants who subsequently develop signs and symptoms (CDC definition) within 14 days of a positive RT-qPCR at baseline or during the EAP [Up to 1 month]

      For all subjects irrespective of baseline serology status (based on central lab test) Cohort B and Cohort B1

    37. Proportion of participants who subsequently develop signs and symptoms (strict-term) within 14 days of a positive RT-qPCR at baseline or during the EAP [Up to 1 month]

      For all subjects irrespective of baseline serology status (based on central lab test) Cohort B and Cohort B1

    38. Number of weeks of symptomatic SARS-CoV-2 infection (CDC definition) within 14 days of a positive RT-qPCR at baseline or during the EAP [Up to 8 months]

      For all subjects irrespective of baseline serology status (based on central lab test) Cohort B and Cohort B1

    39. Number of weeks of symptomatic SARS CoV-2 infection (strict-term) within 14 days of a postive RT-qPCR at baseline or during the EAP [Up to 8 months]

      For all subjects irrespective of baseline serology status (based on central lab test) Cohort B and Cohort B1

    40. Change in viral load (log10 copies/mL) from baseline to day 8 visit in NP swab samples [Up to day 8 visit]

      For all subjects irrespective of baseline serology status (based on central lab test) Cohort B and Cohort B1

    41. Change in viral load (log10 copies/mL) from baseline to day 15 visit in NP swab samples [Up to day 15 visit]

      For all subjects irrespective of baseline serology status (based on central lab test) Cohort B and Cohort B1

    42. Time-weighted average change from baseline in viral load (log10 copies/mL) in NP swab samples until the day 22 visit [Day 22 visit]

      For all subjects irrespective of baseline serology status (based on central lab test) Cohort B and Cohort B1

    43. Area under the curve (AUC) in viral load (log10 copies/mL) in NP swab samples from baseline to the first confirmed negative test [Up to 8 months]

      For all subjects irrespective of baseline serology status (based on central lab test) Cohort B and Cohort B1

    44. Maximum SARS-CoV-2 RT-qPCR viral load (log10 copies/mL) in NP swab samples during the EAP [Up to 1 month]

      For all subjects irrespective of baseline serology status (based on central lab test) Cohort B and Cohort B1

    45. Number of medically attended visits in emergency rooms or urgent care centers related to RT-qPCR confirmed SARS-CoV-2 infection that has an onset at baseline or during the EAP [Up to 8 months]

      For all subjects irrespective of baseline serology status (based on central lab test) Cohort B and Cohort B1

    46. Proportion of participants requiring medically attended visits in emergency rooms or urgent care centers related to a RT-qPCR confirmed SARS CoV-2 infection that has an onset at baseline or during the EAP [Up to 8 months]

      For all subjects irrespective of baseline serology status (based on central lab test) Cohort B and Cohort B1

    47. Proportion of participants hospitalized related to a RT-qPCR confirmed SARS-CoV-2 infection that has an onset at baseline or during the EAP [Up to 8 months]

      For all subjects irrespective of baseline serology status (based on central lab test) Cohort B and Cohort B1

    48. Number of days of hospital and intensive care unit (ICU) stay in participants hospitalized for a RT-qPCR confirmed SARS-CoV-2 infection that has an onset at baseline or during the EAP [Up to 8 months]

      For all subjects irrespective of baseline serology status (based on central lab test) Cohort B and Cohort B1

    49. Number of days missed for daily responsibilities (where applicable) due to a RT-qPCR confirmed SARS-CoV-2 infection that has an onset at baseline or during the EAP [Up to 8 months]

      Daily responsibilities including work (employed adults) or school (students), or family obligations/responsibilities (childcare or eldercare) For all subjects irrespective of baseline serology status (based on central lab test) Cohort B and Cohort B1

    50. Proportion of participants with at least one COVID-19 related hospitalization or emergency room visit associated with a positive RT-qPCR at baseline or during the EAP, or all-cause death [Up to 8 months]

      For all subjects irrespective of baseline serology status (based on central lab test) Cohort B and Cohort B1

    51. Proportion of participants with TEAEs and severity of TEAEs [Up to 8 months]

      For all subjects irrespective of baseline serology status (based on central lab test) Cohort B and Cohort B1

    52. Incidence of symptomatic SARS-CoV-2 infection in both the EAP and follow-up periods [Up to 8 months]

      For all subjects irrespective of baseline serology status (based on central lab test) Cohort B and Cohort B1

    53. Severity of symptomatic SARS-CoV-2 infection in both the EAP and follow-up periods [Up to 8 months]

      For all subjects irrespective of baseline serology status (based on central lab test) Cohort B and Cohort B1

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    1 Day and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Key Inclusion Criteria:

    1. Adult subjects 18 years of age (irrespective of weight) and above at the signing of informed consent or adolescent participants ≥12 to <18 years of age, or pediatric participants <12 years of age at the signing of the assent (parent/guardian sign the informed consent)

    2. Asymptomatic household contact with exposure to an individual with a diagnosis of SARS-CoV-2 infection (index case). To be included in the study, participants must be randomized within 96 hours of collection of the index cases' positive SARS-COV-2 diagnostic test sample

    3. Participant anticipates living in the same household with the index case until study day 29

    4. Is judged by the investigator to be in good health based on medical history and physical examination at screening/baseline, including participants who are healthy or have a chronic, stable medical condition

    5. Willing and able to comply with study visits and study-related procedures/assessments.

    6. Provide informed consent signed by study participant or legally acceptable representative.

    Key Exclusion Criteria:

    1. History of prior positive SARS-CoV-2 RT-PCR test or positive SARS-CoV-2 serology test at any time before the screening

    2. Participant has lived with individuals who have had previous SARS-CoV-2 infection or currently lives with individuals who have SARS-CoV-2 infection, with the exception of the index case(s), the first individual(s) known to be infected in the household

    3. Active respiratory or non-respiratory symptoms consistent with COVID-19

    4. History of respiratory illness with sign/symptoms of SARS-CoV-2 infection, in the opinion of the investigator, within the prior 6 months to screening

    5. Nursing home resident

    6. Any physical examination findings, and/or history of any illness, concomitant medications or recent live vaccines that, in the opinion of the study investigator, might confound the results of the study or pose an additional risk to the participant by their participation in the study

    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 Tucson Arizona United States 85724
    4 Regeneron Study Site La Mesa California United States 91942
    5 Regeneron Study Site La Palma California United States 90623
    6 Regeneron Study Site Long Beach California United States 90806
    7 Regeneron Study Site Los Angeles California United States 90035
    8 Regeneron Study Site Los Angeles California United States 90036
    9 Regeneron Study Site Los Angeles California United States 90095
    10 Regeneron Study Site Montclair California United States 91763
    11 Regeneron Study Site Northridge California United States 91324
    12 Regeneron Study Site Oxnard California United States 93030
    13 Regeneron Study Site Sacramento California United States 95817
    14 Regeneron Study Site Sacramento California United States 95821
    15 Regeneron Study Site San Diego California United States 92108
    16 Regeneron Study Site San Francisco California United States 94127
    17 Regeneron Study Site Stanford California United States 94305
    18 Regeneron Study Site Torrance California United States 90502
    19 Regeneron Study Site Torrance California United States 90505
    20 Regeneron Study Site Aurora Colorado United States 80045
    21 Regeneron Study Site Colorado Springs Colorado United States 80907
    22 Regeneron Study Site Washington District of Columbia United States 20005
    23 Regeneron Study Site Boca Raton Florida United States 33487
    24 Regeneron Study Site Clearwater Florida United States 33756
    25 Regeneron Study Site DeLand Florida United States 32720
    26 Regeneron Study Site Fort Pierce Florida United States 34982
    27 Regeneron Study Site Hialeah Florida United States 33010
    28 Regeneron Study Site Jacksonville Florida United States 32216
    29 Regeneron Study Site Lakeland Florida United States 33810
    30 Regeneron Study Site Loxahatchee Groves Florida United States 33470
    31 Regeneron Study Site Maitland Florida United States 32751
    32 Regeneron Study Site Miami Florida United States 33012
    33 Regeneron Study Site Miami Florida United States 33125
    34 Regeneron Study Site Miami Florida United States 33126
    35 Regeneron Study Site Miami Florida United States 33136
    36 Regeneron Study Site Miami Florida United States 33144
    37 Regeneron Study Site Miami Florida United States 33184
    38 Regeneron Study Site Miami Florida United States 33186
    39 Regeneron Study Site Orlando Florida United States 32803
    40 Regeneron Study Site Sarasota Florida United States 34239
    41 Regeneron Study Site Tampa Florida United States 33612
    42 Regeneron Study Site West Palm Beach Florida United States 33407
    43 Regeneron Study Site Winter Park Florida United States 32789
    44 Regeneron Study Site Atlanta Georgia United States 30303
    45 Regeneron Study Site Atlanta Georgia United States 30322
    46 Regeneron Study Site Columbus Georgia United States 31904
    47 Regeneron Study Site Decatur Georgia United States 30030
    48 Regeneron Study Site Eatonton Georgia United States 31024
    49 Regeneron Study Site Marietta Georgia United States 30060
    50 Regeneron Study Site Sandy Springs Georgia United States 30328
    51 Regeneron Study Site Chicago Illinois United States 60607
    52 Regeneron Study Site 2 Chicago Illinois United States 60612
    53 Regeneron Study Site 3 Chicago Illinois United States 60612
    54 Regeneron Study Site Chicago Illinois United States 60612
    55 Regeneron Study Site 1 Downers Grove Illinois United States 60515
    56 Regeneron Study Site 2 Downers Grove Illinois United States 60515
    57 Regeneron Study Site Ames Iowa United States 50010-3014
    58 Regeneron Study Site Lake Charles Louisiana United States 70601
    59 Regeneron Study Site Marrero Louisiana United States 70072
    60 Regeneron Study Site Metairie Louisiana United States 70006
    61 Regeneron Study Site New Orleans Louisiana United States 70112
    62 Regeneron Study Site Baltimore Maryland United States 21201
    63 Regeneron Study Site Boston Massachusetts United States 02111
    64 Regeneron Study Site Boston Massachusetts United States 02114
    65 Regeneron Study Site Boston Massachusetts United States 02115
    66 Regeneron Study Site Boston Massachusetts United States 02118
    67 Regeneron Study Site Boston Massachusetts United States 02215
    68 Regeneron Study Site Detroit Michigan United States 48202
    69 Regeneron Study Site Royal Oak Michigan United States 48073
    70 Regeneron Study Site Minneapolis Minnesota United States 55455
    71 Regeneron Study Site Gulfport Mississippi United States 39503
    72 Regeneron Study Site Jackson Mississippi United States 39216
    73 Regeneron Study Site Hazelwood Missouri United States 63042
    74 Regeneron Study Site Saint Louis Missouri United States 63110
    75 Regeneron Study Site Las Vegas Nevada United States 89104
    76 Regeneron Study Site Las Vegas Nevada United States 89109
    77 Regeneron Study Site Morristown New Jersey United States 07960
    78 Regeneron Study Site Newark New Jersey United States 07103
    79 Regeneron Study Site Summit New Jersey United States 07901
    80 Regeneron Study Site Teaneck New Jersey United States 07666-4245
    81 Regeneron Study Site 1 Bronx New York United States 10451
    82 Regeneron Study Site 2 Bronx New York United States 10451
    83 Regeneron Study Site Bronx New York United States 10461
    84 Regeneron Study Site Buffalo New York United States 14203
    85 Regeneron Study Site New York New York United States 10016
    86 Regeneron Study Site New York New York United States 10027
    87 Regeneron Study Site New York New York United States 10029
    88 Regeneron Study Site New York New York United States 10032
    89 Regeneron Study Site New York New York United States 10037
    90 Regeneron Study Site New York New York United States 10065
    91 Regeneron Study Site Chapel Hill North Carolina United States 27599
    92 Regeneron Study Site Charlotte North Carolina United States 28209
    93 Regeneron Study Site Fayetteville North Carolina United States 28304
    94 Regeneron Study Site Raleigh North Carolina United States 27612
    95 Regeneron Study Site Wilmington North Carolina United States 28401
    96 Regeneron Study Site Winston-Salem North Carolina United States 27103
    97 Regeneron Study Site Cincinnati Ohio United States 45267-0405
    98 Regeneron Study Site Columbus Ohio United States 43210
    99 Regeneron Study Site Columbus Ohio United States 43215
    100 Regeneron Study Site Dayton Ohio United States 45432
    101 Regeneron Study Site Danville Pennsylvania United States 17822
    102 Regeneron Study Site Philadelphia Pennsylvania United States 19104
    103 Regeneron Study Site Philadelphia Pennsylvania United States 19140
    104 Regeneron Study Site Wilkes-Barre Pennsylvania United States 18711
    105 Regeneron Study Site Providence Rhode Island United States 02906
    106 Regeneron Study Site Charleston South Carolina United States 29406
    107 Regeneron Study Site Charleston South Carolina United States 29425
    108 Regeneron Study Site Clinton South Carolina United States 29325
    109 Regeneron Study Site Gaffney South Carolina United States 29340
    110 Regeneron Study Site Sioux Falls South Dakota United States 57105
    111 Regeneron Study Site Chattanooga Tennessee United States 37421
    112 Regeneron Study Site Knoxville Tennessee United States 37920
    113 Regeneron Study Site Memphis Tennessee United States 38103
    114 Regeneron Study Site Nashville Tennessee United States 37232
    115 Regeneron Study Site Bellaire Texas United States 77401
    116 Regeneron Study Site Corpus Christi Texas United States 78413
    117 Regeneron Study Site Dallas Texas United States 75224
    118 Regeneron Study Site Houston Texas United States 77008
    119 Regeneron Study Site Houston Texas United States 77024
    120 Regeneron Study Site Houston Texas United States 77026
    121 Regeneron Study Site Houston Texas United States 77057
    122 Regeneron Study Site Houston Texas United States 77093
    123 Regeneron Study Site Pearland Texas United States 77584
    124 Regeneron Study Site Red Oak Texas United States 75154
    125 Regeneron Study Site San Antonio Texas United States 78249
    126 Regeneron Study Site Tyler Texas United States 75701
    127 Regeneron Study Site Charlottesville Virginia United States 22903
    128 Regeneron Study Site Richmond Virginia United States 23298
    129 Regeneron Study Site Everett Washington United States 98201
    130 Regeneron Study Site Seattle Washington United States 98104
    131 Regeneron Study Site Yakima Washington United States 98902
    132 Regeneron Study Site Madison Wisconsin United States 53792
    133 Regeneron Study Site Chisinau Moldova, Republic of MD-2025
    134 Regeneron Study Site Bucharest Romania 021105

    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:
    NCT04452318
    Other Study ID Numbers:
    • R10933-10987-COV-2069
    • 2020-003654-71
    First Posted:
    Jun 30, 2020
    Last Update Posted:
    Oct 7, 2021
    Last Verified:
    Oct 1, 2021
    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
    Asymptomatic
    Individuals at risk of exposure to SARS-CoV-2
    Household Contacts of a Person Infected with SARS-CoV-2
    Additional relevant MeSH terms:
    COVID-19

    Study Results

    No Results Posted as of Oct 7, 2021