BLAZE-2: A Study of LY3819253 (LY-CoV555) and LY3832479 (LY-CoV016) in Preventing SARS-CoV-2 Infection and COVID-19 in Nursing Home Residents and Staff

Sponsor
Eli Lilly and Company (Industry)
Overall Status
Completed
CT.gov ID
NCT04497987
Collaborator
National Institute of Allergy and Infectious Diseases (NIAID) (NIH), AbCellera Biologics Inc. (Industry), Shanghai Junshi Bioscience Co., Ltd. (Other)
1,180
Enrollment
27
Locations
9
Arms
9.6
Actual Duration (Months)
43.7
Patients Per Site
4.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate whether LY3819253 given alone and with LY3832479 prevent severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection and coronavirus disease - 2019 (COVID-19). Facility staff and residents in contracted skilled nursing and assisted living facility networks with a high risk of SARS-CoV-2 exposure will receive LY3819253, LY3819253 and LY3832479, or placebo via an injection into a vein. Samples will be taken from the nose. Blood samples will be drawn. Participation could last up to 25 weeks and may include up to 19 visits.

Condition or DiseaseIntervention/TreatmentPhase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
1180 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Prevention
Official Title:
A Phase 3 Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of LY3819253 Alone and in Combination With LY3832479 in Preventing SARS-CoV-2 Infection and COVID-19 in Skilled Nursing and Assisted Living Facility Residents and Staff; a NIAID and Lilly Collaborative Study
Actual Study Start Date :
Aug 2, 2020
Actual Primary Completion Date :
Jan 16, 2021
Actual Study Completion Date :
May 20, 2021

Arms and Interventions

ArmIntervention/Treatment
Experimental: Bamlanivimab (Part 1)

Participants received single Intravenous (IV) infusion of 4200 milligrams (mg) bamlanivimab.

Drug: Bamlanivimab
Administered IV.
Other Names:
  • LY-CoV555
  • LY3819253
  • Placebo Comparator: Placebo (Part 1)

    Participants received single IV infusion of Placebo.

    Drug: Placebo
    Administered IV.

    Experimental: Bamlanivimab (Part 2-Prevention)

    Enrollment for Part 2 was not initiated because the efficacy of Bamlanivimab 4200 mg observed in Part 1 significantly diminished the feasibility of enrolling Part 2.

    Drug: Bamlanivimab
    Administered IV.
    Other Names:
  • LY-CoV555
  • LY3819253
  • Experimental: Bamlanivimab + Etesevimab (Part 2-Prevention)

    Enrollment for Part 2 was not initiated because the efficacy of Bamlanivimab 4200 mg observed in Part 1 significantly diminished the feasibility of enrolling Part 2.

    Drug: Bamlanivimab
    Administered IV.
    Other Names:
  • LY-CoV555
  • LY3819253
  • Drug: Etesevimab
    Administered IV.
    Other Names:
  • LY-CoV016
  • LY3832479
  • Placebo Comparator: Placebo Comparator: Placebo (Part 2-Prevention)

    Enrollment for Part 2 was not initiated because the efficacy of Bamlanivimab 4200 mg observed in Part 1 significantly diminished the feasibility of enrolling Part 2.

    Drug: Placebo
    Administered IV.

    Experimental: Bamlanivimab (Part 2 - Treatment)

    Enrollment for Part 2 was not initiated because the efficacy of Bamlanivimab 4200 mg observed in Part 1 significantly diminished the feasibility of enrolling Part 2.

    Drug: Bamlanivimab
    Administered IV.
    Other Names:
  • LY-CoV555
  • LY3819253
  • Experimental: Bamlanivimab + Etesevimab (Part 2- Treatment)

    Enrollment for Part 2 was not initiated because the efficacy of Bamlanivimab 4200 mg observed in Part 1 significantly diminished the feasibility of enrolling Part 2.

    Drug: Bamlanivimab
    Administered IV.
    Other Names:
  • LY-CoV555
  • LY3819253
  • Drug: Etesevimab
    Administered IV.
    Other Names:
  • LY-CoV016
  • LY3832479
  • Experimental: Bamlanivimab (Part 3)

    Part 3 of the study is exploratory, conducted to study exploratory objectives and is not reported in this record. [Participants received single IV infusion of 700 mg bamlanivimab.]

    Drug: Bamlanivimab
    Administered IV.
    Other Names:
  • LY-CoV555
  • LY3819253
  • Experimental: Bamlanivimab + Etesevimab (Part 3)

    Part 3 of the study is exploratory, conducted to study exploratory objectives and is not reported in this record. [Participants received single IV infusion of 700 mg bamlanivimab given with 1400 mg etesevimab.]

    Drug: Bamlanivimab
    Administered IV.
    Other Names:
  • LY-CoV555
  • LY3819253
  • Drug: Etesevimab
    Administered IV.
    Other Names:
  • LY-CoV016
  • LY3832479
  • Outcome Measures

    Primary Outcome Measures

    1. Percentage of Participants With COVID-19 [Week 8 after randomization]

      The endpoint for the primary analysis is defined as the first occurrence of coronavirus disease - 2019 (COVID-19), defined as the detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) by reverse transcription - polymerase chain reaction (RT-PCR) AND mild or worse disease severity within 21 days of detection, by Day 57 (8 weeks after randomization). The participant needed to test positive on or prior to week 8, and they needed to develop their symptoms on or after their positive test date, but no later than 21 days after their positive swab OR Week 8, whichever comes first. Logistic regression model was used which includes occurrence of a primary endpoint event as the response variable, and treatment and stratification factors such as facility as explanatory variables.

    Secondary Outcome Measures

    1. Percentage of Participants With Moderate or Worse Severity COVID-19 [Week 8 after randomization]

      The endpoint defined as the detection of SARS-CoV-2 by polymerase chain reaction (RT-PCR) AND moderate or worse disease severity within 21 days of detection, by Day 57 (Week 8) were summarized by treatment group. The participant needed to test positive on or prior to week 8, and they needed to develop their symptoms on or after their positive test date, but no later than 21 days after their positive swab OR Week 8, whichever comes first. Logistic regression model was used which includes occurrence of a primary endpoint event as the response variable, and treatment and stratification factors such as facility as explanatory variables.

    2. Percentage of Participants With SARS-CoV-2 [Week 4]

      Percentage of Participants with SARS-CoV-2.

    3. Percentage of Participants Who Are Hospitalized or Have Died Due to COVID-19 [Week 8]

      Percentage of Participants Who are Hospitalized or Have Died due to COVID-19.

    4. Percentage of Participants Who Experience COVID-19-Related Hospitalization, COVID-19 Related Emergency Room Visit, or Death [Week 8]

      Percentage of Participants who Experience COVID-19-Related Hospitalization, COVID-19 Related Emergency Room Visit, or Death.

    5. Percentage of Participants Who Die Due to COVID-19 [Week 8]

      Percentage of Participants Who Die Due to COVID-19.

    6. Pharmacokinetics (PK): Mean Concentration of Bamlanivimab Administered Alone [Day 29, 57, 85, 141 and 169]

      Pharmacokinetics (PK): Mean Concentration of bamlanivimab Administered Alone.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Part 1 and Part 2: Resident or facility staff in a skilled nursing or assisted living facility with at least one confirmed case of SARS-CoV-2 detection less than or equal to (≤)7 days prior to randomization

    • Are men or non-pregnant women who agree to contraceptive requirements

    • Agree to the collection of nasal, mid-turbinate, oropharyngeal, and nasopharyngeal swabs, and venous blood as specified in the schedule of activities

    • Have venous access sufficient to allow intravenous infusions and blood sampling

    • The participant or legally authorized representative give signed informed consent

    • Part 3 only: Resident or staff in a skilled nursing or assisted living facility who satisfy at least one of the following at the time of screening

    • Are greater than or equal to (≥) 65 years of age

    • Have a body mass index (BMI) ≥ 35

    • Have chronic kidney disease

    • Have type 1 or type 2 diabetes

    • Have immunosuppressive disease

    • Are currently receiving immunosuppressive treatment, or

    • Are ≥ 55 years of age AND have

    • cardiovascular disease, OR

    • hypertension, OR

    • chronic obstructive pulmonary disease or other chronic respiratory disease

    • Positive SARS-CoV-2 test and infusion within 10 days of symptom onset, OR positive SARS-CoV-2 test and infusion within 10 days of testing if asymptomatic

    Exclusion Criteria:
    • Parts 1 and 2:

    • Recovered from confirmed COVID-19 disease or asymptomatic infection

    • Prior history of a positive SARS-CoV-2 serology test

    • History of convalescent COVID-19 plasma treatment

    • Participation in a previous SARS-CoV-2 vaccine trial or received an approved SARS-CoV-2 vaccine

    • Previous receipt of SAR-CoV-2-specific monoclonal antibodies

    • Have any serious concomitant systemic disease, condition or disorder that, in the opinion of the investigator, should preclude participation in this study

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1Unv of AL Sch of Med Div of Infectious DiseasesBirminghamAlabamaUnited States35294
    2Care Access ResearchPhoenixArizonaUnited States85023
    3Allergy and Asthma Clin of NW ArkBentonvilleArkansasUnited States72712
    4Care Access Research LLCHuntington BeachCaliforniaUnited States92648
    5Alta Bates SMCOaklandCaliforniaUnited States94609
    6University of Colorado-Anschultz Medical CampusAuroraColoradoUnited States80045
    7NIAIDMiamiFloridaUnited States33136
    8NIAIDDecaturGeorgiaUnited States30030
    9Belmont Village Lincoln ParkLincoln ParkIllinoisUnited States60614
    10Family MedicineIndianapolisIndianaUnited States46260
    11University of LouisvilleLouisvilleKentuckyUnited States40202
    12Care Access Rch Lake CharlesLake CharlesLouisianaUnited States70601
    13Tulane University School of MedicineNew OrleansLouisianaUnited States70112 2715
    14NIAID - National Institute of Allergy & Infectious DiseasesBethesdaMarylandUnited States20892
    15Care AccessBostonMassachusettsUnited States02110
    16St. Paul IDA-CAReSaint PaulMinnesotaUnited States55101
    17Care AccessJacksonMississippiUnited States39206
    18University of Mississippi Medical CenterJacksonMississippiUnited States39216
    19Children's Hospital & Medical CenterOmahaNebraskaUnited States68114
    20Care Access Research - BronxBronxNew YorkUnited States10456
    21NIADChapel HillNorth CarolinaUnited States27599
    22Valley Medical Primary CareCentervilleOhioUnited States45459
    23Univ of Cin College of MedCincinnatiOhioUnited States45219
    24OSU Med Intl Med Houston CtrTulsaOklahomaUnited States74127
    25Donahoe ManorBedfordPennsylvaniaUnited States15522
    26Belmont Village, West UnivHoustonTexasUnited States77025
    27Burke Internal Medicine and ResearchBurkeVirginiaUnited States22015

    Sponsors and Collaborators

    • Eli Lilly and Company
    • National Institute of Allergy and Infectious Diseases (NIAID)
    • AbCellera Biologics Inc.
    • Shanghai Junshi Bioscience Co., Ltd.

    Investigators

    • Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company

    Study Documents (Full-Text)

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Eli Lilly and Company
    ClinicalTrials.gov Identifier:
    NCT04497987
    Other Study ID Numbers:
    • 18063
    • J2X-MC-PYAD
    • CoVPN #3501
    First Posted:
    Aug 4, 2020
    Last Update Posted:
    Feb 4, 2022
    Last Verified:
    Feb 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
    Product Manufactured in and Exported from the U.S.:
    Yes
    Keywords provided by Eli Lilly and Company
    Additional relevant MeSH terms:

    Study Results

    Participant Flow

    Recruitment DetailsThis trial was planned as a 3-part study. Part 1 was to evaluate the efficacy and safety of bamlanivimab (BAM) in preventing severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection and coronavirus disease 2019 (COVID-19), compared with Placebo (PBO). Part 2 was to demonstrate superior efficacy of BAM and BAM + ETE over PBO in the prevention of COVID-19. Part 3 was exploratory cohort.
    Pre-assignment DetailEnrollment for Part 2 was not initiated because the efficacy of BAM 4200 mg observed in Part 1 significantly diminished the feasibility of enrolling Part 2.
    Arm/Group TitlePlacebo4200 mg Bamlanivimab
    Arm/Group DescriptionParticipants received single IV infusion of Placebo.Participants received single IV infusion of 4200 milligrams (mg) bamlanivimab.
    Period Title: Overall Study
    STARTED592588
    Received at Least One Dose of Study Drug587588
    Prevention Population485487
    Treatment Population6866
    Serology Positive3635
    COMPLETED493521
    NOT COMPLETED9967

    Baseline Characteristics

    Arm/Group TitlePlacebo4200 mg BamlanivimabTotal
    Arm/Group DescriptionParticipants received single IV infusion of Placebo.Participants received single IV infusion of 4200 mg bamlanivimab.Total of all reporting groups
    Overall Participants5875881175
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    52.2
    (20.3)
    53.4
    (20.7)
    52.8
    (20.5)
    Sex: Female, Male (Count of Participants)
    Female
    443
    75.5%
    434
    73.8%
    877
    74.6%
    Male
    144
    24.5%
    154
    26.2%
    298
    25.4%
    Ethnicity (NIH/OMB) (Count of Participants)
    Hispanic or Latino
    36
    6.1%
    26
    4.4%
    62
    5.3%
    Not Hispanic or Latino
    551
    93.9%
    561
    95.4%
    1112
    94.6%
    Unknown or Not Reported
    0
    0%
    1
    0.2%
    1
    0.1%
    Race (NIH/OMB) (Count of Participants)
    American Indian or Alaska Native
    1
    0.2%
    4
    0.7%
    5
    0.4%
    Asian
    8
    1.4%
    6
    1%
    14
    1.2%
    Native Hawaiian or Other Pacific Islander
    3
    0.5%
    2
    0.3%
    5
    0.4%
    Black or African American
    52
    8.9%
    48
    8.2%
    100
    8.5%
    White
    515
    87.7%
    519
    88.3%
    1034
    88%
    More than one race
    3
    0.5%
    5
    0.9%
    8
    0.7%
    Unknown or Not Reported
    5
    0.9%
    4
    0.7%
    9
    0.8%
    Region of Enrollment (Count of Participants)
    United States
    587
    100%
    588
    100%
    1175
    100%

    Outcome Measures

    1. Primary Outcome
    TitlePercentage of Participants With COVID-19
    DescriptionThe endpoint for the primary analysis is defined as the first occurrence of coronavirus disease - 2019 (COVID-19), defined as the detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) by reverse transcription - polymerase chain reaction (RT-PCR) AND mild or worse disease severity within 21 days of detection, by Day 57 (8 weeks after randomization). The participant needed to test positive on or prior to week 8, and they needed to develop their symptoms on or after their positive test date, but no later than 21 days after their positive swab OR Week 8, whichever comes first. Logistic regression model was used which includes occurrence of a primary endpoint event as the response variable, and treatment and stratification factors such as facility as explanatory variables.
    Time FrameWeek 8 after randomization

    Outcome Measure Data

    Analysis Population Description
    All randomized participants from prevention population.
    Arm/Group TitlePlacebo4200mg Bamlanivimab
    Arm/Group DescriptionParticipants received single IV infusion of Placebo.Participants received single IV infusion of 4200mg bamlanivimab.
    Measure Participants485487
    Number (95% Confidence Interval) [Percentage of Participants]
    15.7
    2.7%
    8.3
    1.4%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, 4200mg Bamlanivimab
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesisp-Value<0.001
    Comments
    MethodRegression, Logistic
    Comments
    Method of EstimationEstimation ParameterOdds Ratio (OR)
    Estimated Value0.40
    Confidence Interval (2-Sided) 95%
    0.26 to 0.63
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    2. Secondary Outcome
    TitlePercentage of Participants With Moderate or Worse Severity COVID-19
    DescriptionThe endpoint defined as the detection of SARS-CoV-2 by polymerase chain reaction (RT-PCR) AND moderate or worse disease severity within 21 days of detection, by Day 57 (Week 8) were summarized by treatment group. The participant needed to test positive on or prior to week 8, and they needed to develop their symptoms on or after their positive test date, but no later than 21 days after their positive swab OR Week 8, whichever comes first. Logistic regression model was used which includes occurrence of a primary endpoint event as the response variable, and treatment and stratification factors such as facility as explanatory variables.
    Time FrameWeek 8 after randomization

    Outcome Measure Data

    Analysis Population Description
    All randomized participants from prevention population.
    Arm/Group TitlePlacebo4200mg Bamlanivimab
    Arm/Group DescriptionParticipants received single IV infusion of Placebo.Participants received single IV infusion of 4200mg bamlanivimab.
    Measure Participants485487
    Number (95% Confidence Interval) [Percentage of Participants]
    14.7
    2.5%
    8.1
    1.4%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, 4200mg Bamlanivimab
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesisp-Value<0.001
    Comments
    MethodRegression, Logistic
    Comments
    Method of EstimationEstimation ParameterOdds Ratio (OR)
    Estimated Value0.43
    Confidence Interval (2-Sided) 95%
    0.27 to 0.67
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    3. Secondary Outcome
    TitlePercentage of Participants With SARS-CoV-2
    DescriptionPercentage of Participants with SARS-CoV-2.
    Time FrameWeek 4

    Outcome Measure Data

    Analysis Population Description
    All randomized participants from prevention population.
    Arm/Group TitlePlacebo4200mg Bamlanivimab
    Arm/Group DescriptionParticipants received single IV infusion of Placebo.Participants received single IV infusion of 4200mg bamlanivimab.
    Measure Participants485487
    Number (95% Confidence Interval) [Percentage of Participants]
    23.1
    3.9%
    17.8
    3%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, 4200mg Bamlanivimab
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesisp-Value0.021
    Comments
    MethodRegression, Logistic
    Comments
    Method of EstimationEstimation ParameterOdds Ratio (OR)
    Estimated Value0.66
    Confidence Interval (2-Sided) 95%
    0.46 to 0.94
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    4. Secondary Outcome
    TitlePercentage of Participants Who Are Hospitalized or Have Died Due to COVID-19
    DescriptionPercentage of Participants Who are Hospitalized or Have Died due to COVID-19.
    Time FrameWeek 8

    Outcome Measure Data

    Analysis Population Description
    All randomized participants from prevention population.
    Arm/Group TitlePlacebo4200mg Bamlanivimab
    Arm/Group DescriptionParticipants received single IV infusion of Placebo.Participants received single IV infusion of 4200mg bamlanivimab.
    Measure Participants485487
    Number (95% Confidence Interval) [Percentage of Participants]
    1.4
    0.2%
    0.4
    0.1%
    5. Secondary Outcome
    TitlePercentage of Participants Who Experience COVID-19-Related Hospitalization, COVID-19 Related Emergency Room Visit, or Death
    DescriptionPercentage of Participants who Experience COVID-19-Related Hospitalization, COVID-19 Related Emergency Room Visit, or Death.
    Time FrameWeek 8

    Outcome Measure Data

    Analysis Population Description
    All randomized participants from prevention population.
    Arm/Group TitlePlacebo4200mg Bamlanivimab
    Arm/Group DescriptionParticipants received single IV infusion of Placebo.Participants received single IV infusion of 4200mg bamlanivimab.
    Measure Participants485487
    Number (95% Confidence Interval) [Percentage of Participants]
    1.4
    0.2%
    0.6
    0.1%
    6. Secondary Outcome
    TitlePercentage of Participants Who Die Due to COVID-19
    DescriptionPercentage of Participants Who Die Due to COVID-19.
    Time FrameWeek 8

    Outcome Measure Data

    Analysis Population Description
    All randomized participants from prevention population.
    Arm/Group TitlePlacebo4200mg Bamlanivimab
    Arm/Group DescriptionParticipants received single IV infusion of Placebo.Participants received single IV infusion of 4200mg bamlanivimab.
    Measure Participants485487
    Number (95% Confidence Interval) [Percentage of Participants]
    0.8
    0.1%
    0
    0%
    7. Secondary Outcome
    TitlePharmacokinetics (PK): Mean Concentration of Bamlanivimab Administered Alone
    DescriptionPharmacokinetics (PK): Mean Concentration of bamlanivimab Administered Alone.
    Time FrameDay 29, 57, 85, 141 and 169

    Outcome Measure Data

    Analysis Population Description
    All randomized participants who received at least one dose of bamlanivimab and had evaluable PK data.
    Arm/Group Title4200mg Bamlanivimab
    Arm/Group DescriptionParticipants received single IV infusion of 4200mg bamlanivimab.
    Measure Participants557
    Day 29
    162
    (44.4)
    Day 57
    61.8
    (59.9)
    Day 85
    28.4
    (61.6)
    Day 141
    17.5
    (46.2)
    Day 169
    15.1
    (42.3)

    Adverse Events

    Time FrameBaseline, up to 9 Months
    Adverse Event Reporting Description All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
    Arm/Group TitlePlacebo4200mg Bamlanivimab
    Arm/Group DescriptionParticipants received single IV infusion of Placebo.Participants received single IV infusion of 4200mg bamlanivimab.
    All Cause Mortality
    Placebo4200mg Bamlanivimab
    Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
    Total21/587 (3.6%) 13/588 (2.2%)
    Serious Adverse Events
    Placebo4200mg Bamlanivimab
    Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
    Total30/587 (5.1%) 39/588 (6.6%)
    Blood and lymphatic system disorders
    Anaemia0/587 (0%) 01/588 (0.2%) 1
    Iron deficiency anaemia0/587 (0%) 01/588 (0.2%) 1
    Thrombocytopenia0/587 (0%) 01/588 (0.2%) 1
    Cardiac disorders
    Acute myocardial infarction0/587 (0%) 02/588 (0.3%) 2
    Atrial fibrillation0/587 (0%) 03/588 (0.5%) 3
    Cardiac failure0/587 (0%) 01/588 (0.2%) 1
    Cardiac failure acute0/587 (0%) 00/588 (0%) 0
    Cardiac failure congestive2/587 (0.3%) 32/588 (0.3%) 2
    Cardio-respiratory arrest1/587 (0.2%) 11/588 (0.2%) 1
    Cardiomyopathy0/587 (0%) 00/588 (0%) 0
    Coronary artery disease1/587 (0.2%) 11/588 (0.2%) 1
    Myocardial infarction1/587 (0.2%) 11/588 (0.2%) 1
    Endocrine disorders
    Thyrotoxic crisis1/587 (0.2%) 10/588 (0%) 0
    Gastrointestinal disorders
    Abdominal distension1/587 (0.2%) 10/588 (0%) 0
    Abdominal pain upper0/587 (0%) 00/588 (0%) 0
    Ascites1/587 (0.2%) 10/588 (0%) 0
    Gastrointestinal haemorrhage0/587 (0%) 01/588 (0.2%) 1
    Mouth haemorrhage1/587 (0.2%) 10/588 (0%) 0
    Oesophageal ulcer1/587 (0.2%) 10/588 (0%) 0
    Small intestinal obstruction0/587 (0%) 01/588 (0.2%) 1
    General disorders
    Death1/587 (0.2%) 11/588 (0.2%) 1
    Gait disturbance0/587 (0%) 01/588 (0.2%) 1
    Sudden death0/587 (0%) 00/588 (0%) 0
    Hepatobiliary disorders
    Bile duct stone0/587 (0%) 01/588 (0.2%) 1
    Hepatic cirrhosis0/587 (0%) 00/588 (0%) 0
    Infections and infestations
    Acquired immunodeficiency syndrome0/587 (0%) 01/588 (0.2%) 1
    Bacteraemia1/587 (0.2%) 10/588 (0%) 0
    Clostridium difficile infection0/587 (0%) 00/588 (0%) 0
    Escherichia bacteraemia0/587 (0%) 01/588 (0.2%) 1
    Escherichia urinary tract infection1/587 (0.2%) 10/588 (0%) 0
    Gastroenteritis0/587 (0%) 01/588 (0.2%) 1
    Groin abscess0/587 (0%) 01/588 (0.2%) 1
    Osteomyelitis1/587 (0.2%) 10/588 (0%) 0
    Pneumonia2/587 (0.3%) 22/588 (0.3%) 2
    Pyelonephritis1/587 (0.2%) 10/588 (0%) 0
    Sepsis3/587 (0.5%) 33/588 (0.5%) 3
    Septic shock1/587 (0.2%) 12/588 (0.3%) 2
    Upper respiratory tract infection1/587 (0.2%) 10/588 (0%) 0
    Urinary tract infection0/587 (0%) 05/588 (0.9%) 6
    Injury, poisoning and procedural complications
    Fall2/587 (0.3%) 20/588 (0%) 0
    Femur fracture1/587 (0.2%) 10/588 (0%) 0
    Hip fracture1/587 (0.2%) 10/588 (0%) 0
    Injury corneal1/587 (0.2%) 10/588 (0%) 0
    Limb injury0/587 (0%) 00/588 (0%) 0
    Multiple injuries0/587 (0%) 01/588 (0.2%) 1
    Open globe injury1/587 (0.2%) 10/588 (0%) 0
    Road traffic accident0/587 (0%) 01/588 (0.2%) 1
    Spinal compression fracture0/587 (0%) 01/588 (0.2%) 1
    Investigations
    Blood creatinine increased1/587 (0.2%) 10/588 (0%) 0
    Metabolism and nutrition disorders
    Hyperkalaemia1/587 (0.2%) 10/588 (0%) 0
    Hypoglycaemia0/587 (0%) 01/588 (0.2%) 1
    Musculoskeletal and connective tissue disorders
    Lumbar spinal stenosis0/587 (0%) 01/588 (0.2%) 1
    Nervous system disorders
    Cerebrovascular accident1/587 (0.2%) 11/588 (0.2%) 1
    Dementia1/587 (0.2%) 10/588 (0%) 0
    Headache0/587 (0%) 01/588 (0.2%) 1
    Hypoaesthesia0/587 (0%) 01/588 (0.2%) 1
    Metabolic encephalopathy0/587 (0%) 00/588 (0%) 0
    Paraesthesia0/587 (0%) 02/588 (0.3%) 2
    Syncope1/587 (0.2%) 10/588 (0%) 0
    Transient ischaemic attack0/587 (0%) 02/588 (0.3%) 2
    Pregnancy, puerperium and perinatal conditions
    Abortion spontaneous1/443 (0.2%) 10/434 (0%) 0
    Psychiatric disorders
    Depression suicidal0/587 (0%) 01/588 (0.2%) 1
    Mental status changes0/587 (0%) 01/588 (0.2%) 2
    Post-traumatic stress disorder0/587 (0%) 01/588 (0.2%) 1
    Renal and urinary disorders
    Acute kidney injury1/587 (0.2%) 11/588 (0.2%) 1
    End stage renal disease1/587 (0.2%) 11/588 (0.2%) 1
    Nephrolithiasis1/587 (0.2%) 10/588 (0%) 0
    Renal artery stenosis1/587 (0.2%) 10/588 (0%) 0
    Ureterolithiasis1/587 (0.2%) 10/588 (0%) 0
    Respiratory, thoracic and mediastinal disorders
    Acute respiratory failure0/587 (0%) 02/588 (0.3%) 2
    Chronic obstructive pulmonary disease0/587 (0%) 02/588 (0.3%) 2
    Epistaxis1/587 (0.2%) 10/588 (0%) 0
    Hypoxia0/587 (0%) 01/588 (0.2%) 1
    Pneumonia aspiration0/587 (0%) 01/588 (0.2%) 1
    Pulmonary mass1/587 (0.2%) 10/588 (0%) 0
    Respiratory failure0/587 (0%) 01/588 (0.2%) 1
    Skin and subcutaneous tissue disorders
    Hyperhidrosis0/587 (0%) 00/588 (0%) 0
    Ingrowing nail0/587 (0%) 00/588 (0%) 0
    Vascular disorders
    Hypovolaemic shock1/587 (0.2%) 10/588 (0%) 0
    Lymphoedema0/587 (0%) 01/588 (0.2%) 1
    Other (Not Including Serious) Adverse Events
    Placebo4200mg Bamlanivimab
    Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
    Total147/587 (25%) 145/588 (24.7%)
    Blood and lymphatic system disorders
    Anaemia2/587 (0.3%) 21/588 (0.2%) 1
    Leukocytosis1/587 (0.2%) 10/588 (0%) 0
    Thrombocytopenia2/587 (0.3%) 20/588 (0%) 0
    Cardiac disorders
    Angina pectoris0/587 (0%) 01/588 (0.2%) 1
    Atrial thrombosis0/587 (0%) 01/588 (0.2%) 1
    Cardiac failure congestive1/587 (0.2%) 11/588 (0.2%) 1
    Cardiomegaly1/587 (0.2%) 10/588 (0%) 0
    Palpitations0/587 (0%) 03/588 (0.5%) 3
    Sinus bradycardia1/587 (0.2%) 10/588 (0%) 0
    Tachycardia0/587 (0%) 01/588 (0.2%) 1
    Ventricular fibrillation0/587 (0%) 01/588 (0.2%) 1
    Ear and labyrinth disorders
    Ear pain0/587 (0%) 02/588 (0.3%) 3
    Eustachian tube dysfunction0/587 (0%) 01/588 (0.2%) 1
    Excessive cerumen production1/587 (0.2%) 10/588 (0%) 0
    Tinnitus1/587 (0.2%) 11/588 (0.2%) 1
    Vertigo1/587 (0.2%) 15/588 (0.9%) 5
    Endocrine disorders
    Adrenal insufficiency0/587 (0%) 00/588 (0%) 0
    Hyperparathyroidism1/587 (0.2%) 10/588 (0%) 0
    Eye disorders
    Eye discharge0/587 (0%) 01/588 (0.2%) 1
    Eye pruritus1/587 (0.2%) 10/588 (0%) 0
    Retinal detachment1/587 (0.2%) 10/588 (0%) 0
    Gastrointestinal disorders
    Abdominal discomfort1/587 (0.2%) 11/588 (0.2%) 1
    Abdominal hernia1/587 (0.2%) 10/588 (0%) 0
    Abdominal pain2/587 (0.3%) 22/588 (0.3%) 2
    Abdominal pain upper0/587 (0%) 01/588 (0.2%) 1
    Anal incontinence0/587 (0%) 00/588 (0%) 0
    Aphthous ulcer1/587 (0.2%) 10/588 (0%) 0
    Constipation3/587 (0.5%) 33/588 (0.5%) 3
    Dental caries1/587 (0.2%) 10/588 (0%) 0
    Diarrhoea0/587 (0%) 01/588 (0.2%) 2
    Dyspepsia2/587 (0.3%) 22/588 (0.3%) 3
    Faecaloma1/587 (0.2%) 10/588 (0%) 0
    Gastric disorder0/587 (0%) 01/588 (0.2%) 1
    Gastrooesophageal reflux disease1/587 (0.2%) 13/588 (0.5%) 3
    Glossodynia0/587 (0%) 01/588 (0.2%) 1
    Large intestine polyp0/587 (0%) 01/588 (0.2%) 1
    Mouth ulceration0/587 (0%) 01/588 (0.2%) 1
    Nausea1/587 (0.2%) 11/588 (0.2%) 1
    Oesophagitis1/587 (0.2%) 10/588 (0%) 0
    Oral pain1/587 (0.2%) 10/588 (0%) 0
    Stomatitis0/587 (0%) 01/588 (0.2%) 1
    Toothache0/587 (0%) 01/588 (0.2%) 1
    Upper gastrointestinal haemorrhage0/587 (0%) 00/588 (0%) 0
    Vomiting0/587 (0%) 01/588 (0.2%) 1
    General disorders
    Asthenia1/587 (0.2%) 10/588 (0%) 0
    Chest pain0/587 (0%) 01/588 (0.2%) 1
    Face oedema1/587 (0.2%) 10/588 (0%) 0
    Feeling hot0/587 (0%) 00/588 (0%) 0
    Infusion site haemorrhage0/587 (0%) 01/588 (0.2%) 1
    Injection site extravasation0/587 (0%) 01/588 (0.2%) 1
    Non-cardiac chest pain1/587 (0.2%) 11/588 (0.2%) 1
    Oedema1/587 (0.2%) 11/588 (0.2%) 1
    Oedema peripheral0/587 (0%) 01/588 (0.2%) 1
    Puncture site haematoma1/587 (0.2%) 10/588 (0%) 0
    Pyrexia0/587 (0%) 01/588 (0.2%) 1
    Swelling face0/587 (0%) 01/588 (0.2%) 1
    Hepatobiliary disorders
    Hepatic cirrhosis1/587 (0.2%) 10/588 (0%) 0
    Hepatic function abnormal1/587 (0.2%) 10/588 (0%) 0
    Immune system disorders
    Food allergy0/587 (0%) 01/588 (0.2%) 1
    Hypersensitivity0/587 (0%) 01/588 (0.2%) 1
    Serum sickness1/587 (0.2%) 10/588 (0%) 0
    Infections and infestations
    Abscess0/587 (0%) 00/588 (0%) 0
    Bronchitis3/587 (0.5%) 31/588 (0.2%) 1
    Candida infection2/587 (0.3%) 20/588 (0%) 0
    Cellulitis1/587 (0.2%) 11/588 (0.2%) 1
    Clostridium difficile infection0/587 (0%) 02/588 (0.3%) 2
    Conjunctivitis1/587 (0.2%) 10/588 (0%) 0
    Cystitis1/587 (0.2%) 10/588 (0%) 0
    Device related infection1/587 (0.2%) 10/588 (0%) 0
    Diverticulitis1/587 (0.2%) 10/588 (0%) 0
    Ear infection2/587 (0.3%) 22/588 (0.3%) 2
    Endocarditis0/587 (0%) 01/588 (0.2%) 1
    Eye infection1/587 (0.2%) 10/588 (0%) 0
    Fungal infection1/587 (0.2%) 10/588 (0%) 0
    Gastrointestinal bacterial infection0/587 (0%) 01/588 (0.2%) 1
    Kidney infection1/587 (0.2%) 10/588 (0%) 0
    Labyrinthitis0/587 (0%) 01/588 (0.2%) 1
    Localised infection0/587 (0%) 01/588 (0.2%) 1
    Nasopharyngitis1/587 (0.2%) 12/588 (0.3%) 2
    Oral candidiasis0/587 (0%) 01/588 (0.2%) 1
    Oral herpes0/587 (0%) 00/588 (0%) 0
    Osteomyelitis0/587 (0%) 01/588 (0.2%) 1
    Pharyngitis streptococcal2/587 (0.3%) 20/588 (0%) 0
    Pilonidal cyst1/587 (0.2%) 10/588 (0%) 0
    Pneumonia7/587 (1.2%) 72/588 (0.3%) 2
    Rhinitis1/587 (0.2%) 11/588 (0.2%) 1
    Sinusitis8/587 (1.4%) 82/588 (0.3%) 2
    Subcutaneous abscess0/587 (0%) 01/588 (0.2%) 1
    Tooth abscess1/587 (0.2%) 13/588 (0.5%) 3
    Tooth infection0/587 (0%) 03/588 (0.5%) 4
    Urinary tract infection20/587 (3.4%) 2211/588 (1.9%) 13
    Vaginal infection0/443 (0%) 01/434 (0.2%) 1
    Viral infection0/587 (0%) 01/588 (0.2%) 1
    Injury, poisoning and procedural complications
    Animal bite1/587 (0.2%) 10/588 (0%) 0
    Animal scratch1/587 (0.2%) 10/588 (0%) 0
    Concussion0/587 (0%) 01/588 (0.2%) 1
    Contusion2/587 (0.3%) 23/588 (0.5%) 3
    Fall9/587 (1.5%) 126/588 (1%) 6
    Foot fracture1/587 (0.2%) 10/588 (0%) 0
    Head injury1/587 (0.2%) 10/588 (0%) 0
    Humerus fracture1/587 (0.2%) 10/588 (0%) 0
    Joint dislocation1/587 (0.2%) 10/588 (0%) 0
    Joint injury1/587 (0.2%) 10/588 (0%) 0
    Ligament sprain1/587 (0.2%) 10/588 (0%) 0
    Limb injury2/587 (0.3%) 20/588 (0%) 0
    Lower limb fracture1/587 (0.2%) 10/588 (0%) 0
    Lumbar vertebral fracture0/587 (0%) 01/588 (0.2%) 1
    Muscle strain1/587 (0.2%) 10/588 (0%) 0
    Rib fracture0/587 (0%) 01/588 (0.2%) 1
    Skin laceration1/587 (0.2%) 12/588 (0.3%) 3
    Soft tissue injury1/587 (0.2%) 10/588 (0%) 0
    Spinal compression fracture0/587 (0%) 01/588 (0.2%) 1
    Tibia fracture2/587 (0.3%) 20/588 (0%) 0
    Tooth fracture1/587 (0.2%) 10/588 (0%) 0
    Vaccination complication1/587 (0.2%) 10/588 (0%) 0
    Wrist fracture0/587 (0%) 01/588 (0.2%) 1
    Investigations
    Alanine aminotransferase increased0/587 (0%) 01/588 (0.2%) 1
    Amylase increased1/587 (0.2%) 10/588 (0%) 0
    Aspartate aminotransferase increased0/587 (0%) 01/588 (0.2%) 1
    Blood albumin decreased0/587 (0%) 02/588 (0.3%) 2
    Blood alkaline phosphatase increased1/587 (0.2%) 10/588 (0%) 0
    Blood bilirubin increased1/587 (0.2%) 11/588 (0.2%) 1
    Blood creatinine increased1/587 (0.2%) 10/588 (0%) 0
    Blood glucose increased2/587 (0.3%) 21/588 (0.2%) 1
    Blood potassium decreased0/587 (0%) 01/588 (0.2%) 2
    Blood pressure increased1/587 (0.2%) 13/588 (0.5%) 3
    Blood sodium decreased1/587 (0.2%) 10/588 (0%) 0
    Blood urea increased1/587 (0.2%) 11/588 (0.2%) 1
    Brain natriuretic peptide increased0/587 (0%) 01/588 (0.2%) 1
    Breath sounds abnormal0/587 (0%) 00/588 (0%) 0
    C-reactive protein increased1/587 (0.2%) 10/588 (0%) 0
    Capillary nail refill test abnormal0/587 (0%) 00/588 (0%) 0
    Gamma-glutamyltransferase increased2/587 (0.3%) 21/588 (0.2%) 1
    Haemoglobin increased1/587 (0.2%) 10/588 (0%) 0
    Hepatic enzyme increased0/587 (0%) 01/588 (0.2%) 1
    International normalised ratio increased0/587 (0%) 00/588 (0%) 0
    Neutrophil count decreased0/587 (0%) 01/588 (0.2%) 1
    Neutrophil count increased1/587 (0.2%) 10/588 (0%) 0
    Procalcitonin increased0/587 (0%) 00/588 (0%) 0
    Smear cervix abnormal0/443 (0%) 01/434 (0.2%) 1
    Troponin increased0/587 (0%) 01/588 (0.2%) 1
    White blood cell count decreased0/587 (0%) 01/588 (0.2%) 1
    White blood cell count increased1/587 (0.2%) 10/588 (0%) 0
    Metabolism and nutrition disorders
    Dehydration3/587 (0.5%) 41/588 (0.2%) 1
    Dyslipidaemia1/587 (0.2%) 10/588 (0%) 0
    Glucose tolerance impaired1/587 (0.2%) 10/588 (0%) 0
    Gout0/587 (0%) 01/588 (0.2%) 1
    Hypercalcaemia1/587 (0.2%) 10/588 (0%) 0
    Hyperkalaemia2/587 (0.3%) 20/588 (0%) 0
    Hyperlipidaemia1/587 (0.2%) 10/588 (0%) 0
    Hyperproteinaemia1/587 (0.2%) 10/588 (0%) 0
    Hypoalbuminaemia0/587 (0%) 00/588 (0%) 0
    Hypokalaemia2/587 (0.3%) 21/588 (0.2%) 1
    Metabolic acidosis1/587 (0.2%) 10/588 (0%) 0
    Vitamin b complex deficiency0/587 (0%) 01/588 (0.2%) 1
    Vitamin d deficiency0/587 (0%) 02/588 (0.3%) 2
    Musculoskeletal and connective tissue disorders
    Arthralgia4/587 (0.7%) 47/588 (1.2%) 8
    Back pain6/587 (1%) 65/588 (0.9%) 5
    Bursitis0/587 (0%) 01/588 (0.2%) 1
    Coccydynia0/587 (0%) 01/588 (0.2%) 1
    Flank pain1/587 (0.2%) 10/588 (0%) 0
    Inguinal mass1/587 (0.2%) 10/588 (0%) 0
    Intervertebral disc degeneration1/587 (0.2%) 10/588 (0%) 0
    Intervertebral disc protrusion1/587 (0.2%) 10/588 (0%) 0
    Joint effusion0/587 (0%) 01/588 (0.2%) 1
    Joint range of motion decreased0/587 (0%) 01/588 (0.2%) 1
    Joint swelling0/587 (0%) 01/588 (0.2%) 1
    Muscle spasms1/587 (0.2%) 11/588 (0.2%) 1
    Neck pain2/587 (0.3%) 22/588 (0.3%) 2
    Osteonecrosis0/587 (0%) 01/588 (0.2%) 1
    Pain in extremity3/587 (0.5%) 34/588 (0.7%) 4
    Sjogren's syndrome1/587 (0.2%) 10/588 (0%) 0
    Spinal stenosis0/587 (0%) 01/588 (0.2%) 1
    Trochlear dysplasia1/587 (0.2%) 10/588 (0%) 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Cervix carcinoma1/443 (0.2%) 10/434 (0%) 0
    Plasma cell myeloma1/587 (0.2%) 10/588 (0%) 0
    Prostate cancer1/144 (0.7%) 10/154 (0%) 0
    Seborrhoeic keratosis0/587 (0%) 00/588 (0%) 0
    Nervous system disorders
    Bell's palsy0/587 (0%) 01/588 (0.2%) 1
    Carpal tunnel syndrome1/587 (0.2%) 10/588 (0%) 0
    Cubital tunnel syndrome1/587 (0.2%) 10/588 (0%) 0
    Dizziness6/587 (1%) 65/588 (0.9%) 6
    Dizziness postural1/587 (0.2%) 10/588 (0%) 0
    Dysgeusia0/587 (0%) 01/588 (0.2%) 1
    Headache2/587 (0.3%) 22/588 (0.3%) 2
    Hypoaesthesia0/587 (0%) 02/588 (0.3%) 2
    Metabolic encephalopathy1/587 (0.2%) 10/588 (0%) 0
    Migraine1/587 (0.2%) 10/588 (0%) 0
    Paraesthesia1/587 (0.2%) 10/588 (0%) 0
    Sciatica0/587 (0%) 01/588 (0.2%) 1
    Syncope3/587 (0.5%) 31/588 (0.2%) 1
    Tremor0/587 (0%) 01/588 (0.2%) 1
    Psychiatric disorders
    Anorgasmia0/587 (0%) 01/588 (0.2%) 1
    Anxiety0/587 (0%) 02/588 (0.3%) 2
    Anxiety disorder1/587 (0.2%) 10/588 (0%) 0
    Confusional state0/587 (0%) 01/588 (0.2%) 1
    Delusion1/587 (0.2%) 10/588 (0%) 0
    Depression1/587 (0.2%) 13/588 (0.5%) 3
    Generalised anxiety disorder0/587 (0%) 00/588 (0%) 0
    Insomnia2/587 (0.3%) 21/588 (0.2%) 1
    Mental status changes1/587 (0.2%) 10/588 (0%) 0
    Renal and urinary disorders
    Acute kidney injury0/587 (0%) 01/588 (0.2%) 1
    Bladder spasm1/587 (0.2%) 10/588 (0%) 0
    Dysuria0/587 (0%) 01/588 (0.2%) 1
    Haematuria2/587 (0.3%) 20/588 (0%) 0
    Nephrolithiasis3/587 (0.5%) 30/588 (0%) 0
    Renal failure1/587 (0.2%) 10/588 (0%) 0
    Renal impairment1/587 (0.2%) 10/588 (0%) 0
    Urinary tract obstruction1/587 (0.2%) 10/588 (0%) 0
    Reproductive system and breast disorders
    Breast mass1/587 (0.2%) 10/588 (0%) 0
    Dysmenorrhoea0/443 (0%) 01/434 (0.2%) 1
    Ovarian cyst ruptured1/443 (0.2%) 10/434 (0%) 0
    Vulvovaginal pruritus0/443 (0%) 01/434 (0.2%) 1
    Respiratory, thoracic and mediastinal disorders
    Asthma1/587 (0.2%) 10/588 (0%) 0
    Chronic obstructive pulmonary disease1/587 (0.2%) 11/588 (0.2%) 1
    Dysphonia1/587 (0.2%) 11/588 (0.2%) 1
    Dyspnoea0/587 (0%) 01/588 (0.2%) 1
    Epistaxis2/587 (0.3%) 22/588 (0.3%) 2
    Haemoptysis0/587 (0%) 01/588 (0.2%) 1
    Hypoxia0/587 (0%) 01/588 (0.2%) 1
    Nasal congestion5/587 (0.9%) 51/588 (0.2%) 1
    Oropharyngeal pain1/587 (0.2%) 10/588 (0%) 0
    Paranasal sinus discomfort0/587 (0%) 01/588 (0.2%) 1
    Pharyngeal paraesthesia1/587 (0.2%) 10/588 (0%) 0
    Pulmonary fibrosis0/587 (0%) 00/588 (0%) 0
    Sinus congestion0/587 (0%) 01/588 (0.2%) 1
    Sinus pain1/587 (0.2%) 10/588 (0%) 0
    Sleep apnoea syndrome0/587 (0%) 00/588 (0%) 0
    Sneezing1/587 (0.2%) 10/588 (0%) 0
    Wheezing1/587 (0.2%) 10/588 (0%) 0
    Skin and subcutaneous tissue disorders
    Decubitus ulcer0/587 (0%) 00/588 (0%) 0
    Dermatitis allergic1/587 (0.2%) 10/588 (0%) 0
    Dermatitis contact0/587 (0%) 01/588 (0.2%) 1
    Diabetic foot1/587 (0.2%) 10/588 (0%) 0
    Ecchymosis0/587 (0%) 02/588 (0.3%) 2
    Eczema1/587 (0.2%) 10/588 (0%) 0
    Erythema1/587 (0.2%) 12/588 (0.3%) 2
    Hyperhidrosis1/587 (0.2%) 11/588 (0.2%) 1
    Night sweats0/587 (0%) 01/588 (0.2%) 1
    Pruritus1/587 (0.2%) 12/588 (0.3%) 2
    Rash1/587 (0.2%) 15/588 (0.9%) 5
    Skin exfoliation1/587 (0.2%) 10/588 (0%) 0
    Skin ulcer0/587 (0%) 01/588 (0.2%) 1
    Skin wrinkling0/587 (0%) 00/588 (0%) 0
    Stasis dermatitis0/587 (0%) 00/588 (0%) 0
    Urticaria1/587 (0.2%) 14/588 (0.7%) 4
    Surgical and medical procedures
    Dental operation1/587 (0.2%) 10/588 (0%) 0
    Knee arthroplasty1/587 (0.2%) 10/588 (0%) 0
    Retinopexy0/587 (0%) 01/588 (0.2%) 1
    Salpingo-oophorectomy unilateral1/443 (0.2%) 10/434 (0%) 0
    Sinus operation0/587 (0%) 01/588 (0.2%) 1
    Spinal laminectomy0/587 (0%) 01/588 (0.2%) 1
    Tooth extraction0/587 (0%) 01/588 (0.2%) 1
    Vascular disorders
    Aortic arteriosclerosis1/587 (0.2%) 10/588 (0%) 0
    Deep vein thrombosis0/587 (0%) 01/588 (0.2%) 1
    Flushing2/587 (0.3%) 22/588 (0.3%) 2
    Haematoma1/587 (0.2%) 11/588 (0.2%) 1
    Hypertension11/587 (1.9%) 118/588 (1.4%) 8
    Hypotension1/587 (0.2%) 10/588 (0%) 0
    Lymphoedema0/587 (0%) 01/588 (0.2%) 1

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

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

    The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.

    Results Point of Contact

    Name/TitleChief Medical Officer
    OrganizationEli Lilly and Company
    Phone800-545-5979
    EmailClinicalTrials.gov@lilly.com
    Responsible Party:
    Eli Lilly and Company
    ClinicalTrials.gov Identifier:
    NCT04497987
    Other Study ID Numbers:
    • 18063
    • J2X-MC-PYAD
    • CoVPN #3501
    First Posted:
    Aug 4, 2020
    Last Update Posted:
    Feb 4, 2022
    Last Verified:
    Feb 1, 2022