A Study of Immune System Proteins in Participants With Mi... | NCT04634409 | Trialant
NCT04634409
Sponsor
Eli Lilly and Company
Status
Completed
Last Update Posted
Jul 1, 2022Actual
Enrollment
1,755Actual
Phase
Phase 2
Conditions
COVID-19
Interventions
Bamlanivimab
Etesevimab
Placebo
VIR-7831
Bebtelovimab
Countries
United States
Argentina
Puerto Rico
Protocol Section
Identification Module
NCT ID
NCT04634409
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
18160
Secondary IDs
ID
Type
Description
Link
J2X-MC-PYAH
Other Identifier
Eli Lilly and Company
Brief Title
A Study of Immune System Proteins in Participants With Mild to Moderate COVID-19 Illness
Official Title
A Randomized, Double-blind, Placebo-Controlled, Phase 2 Study to Evaluate the Efficacy and Safety of Mono and Combination Therapy With Monoclonal Antibodies in Participants With Mild to Moderate COVID-19 Illness (BLAZE-4)
Acronym
BLAZE-4
Organization
Eli Lilly and CompanyINDUSTRY
Status Module
Record Verification Date
Jun 2022
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Oct 29, 2020Actual
Primary Completion Date
Jul 27, 2021Actual
Completion Date
Oct 18, 2021Actual
First Submitted Date
Nov 17, 2020
First Submission Date that Met QC Criteria
Nov 17, 2020
First Posted Date
Nov 18, 2020Actual
Results Waived
Not provided
Results First Submitted Date
Jun 7, 2022
Results First Submitted that Met QC Criteria
Jun 7, 2022
Results First Posted Date
Jul 1, 2022Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Jun 7, 2022
Last Update Posted Date
Jul 1, 2022Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Eli Lilly and CompanyINDUSTRY
Collaborators
Name
Class
AbCellera Biologics Inc.
INDUSTRY
Shanghai Junshi Bioscience Co., Ltd.
OTHER
GlaxoSmithKline
INDUSTRY
Vir Biotechnology, Inc.
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The purpose of this study is to measure how well monoclonal antibodies work, either alone or in combination, against the virus that causes COVID-19. Study drug(s) will be given to participants with early symptoms of COVID-19. Samples will be taken from the back of the nose to determine how much virus is in the body at various times during the study. Participation could last about 12 or 24 weeks and includes at least 1 visit to the study site, with the remainder of assessments performed in the home, local clinic, or by phone.
Detailed Description
Not provided
Conditions Module
Conditions
COVID-19
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
1,755Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Placebo (Pbo)
Placebo Comparator
Treatment 1: Pbo administered intravenously (IV).
Treatment 8: Pbo For 700 mg Bamlanivimab (BAM) + 500 mg VIR-7831 (Amendment (C-e)) administered IV.
Treatment 1-6 and Unintentional Dosing Arms: Percentage of Participants With Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Viral Load Greater Than 5.27
Percentage of participants with SARS-CoV-2 viral load greater than 5.27 on Day 7. Missing data is estimated using Relevance Sequence Imputation (RSI). RSI is defined as follows: If Day 7 SARS-CoV-2 viral load is missing, then Day 7 will be imputed using data from the first available for Day 5, Day 3, Day 11, or Day 1.
Day 7
Treatment 7-8, Amendments (C-e): Percentage of Participants With SARS-CoV-2 Viral Load Greater Than 5.27
Percentage of participants with SARS-CoV-2 viral load greater than 5.27 on Day 7. Missing data is estimated using Last Observation Carried Forward (LOCF).
Day 7
Treatment 9-11 Amendment (f), Low Risk Participants: Percentage of Participants With SARS-CoV-2 Viral Load Greater Than 5.27
Percentage of participants with SARS-CoV-2 viral load greater than 5.27 on Day 7. Missing data is estimated using Last Observation Carried Forward (LOCF).
Day 7
Secondary Outcomes
Measure
Description
Time Frame
Treatment 12 -13, Amendment (f) High Risk Participants: Percentage of Participants With SARS-CoV-2 Viral Load Greater Than 5.27
Percentage of participants with SARS-CoV-2 viral load greater than 5.27 on Day 7. Missing data is estimated using Last Observation Carried Forward (LOCF).
Day 7
Treatment 14, Amendment (f) High Risk Participants Updated CDC Criteria: Percentage of Participants With SARS-CoV-2 Viral Load Greater Than 5.27
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
For low-risk participant arms 9-11 only: Are greater than or equal to (≥)18 and less than (<)65 years of age at the time of randomization and do not have the risk factors defined in the bullet point directly below
For high-risk participant arms 12 and 13 only:
-- Are ≥18 years of age and satisfy at least one of the following risk factors at the time of screening
Are ≥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
For high-risk participant arms 12 and 13 only:
Are 12-17 years of age (inclusive) AND satisfy at least one of the following risk factors at the time of screening
Have neurodevelopmental disorders, for example, cerebral palsy
Have a medical-related technological dependence, for example, tracheostomy, gastrostomy, or positive pressure ventilation (not related to COVID-19)
Have asthma or reactive airway or other chronic respiratory disease that requires daily medication for control
Have type 1 or type 2 diabetes
Have chronic kidney disease
Have immunosuppressive disease, or
Are currently receiving immunosuppressive treatment.
For high-risk participants arm 14 only:
Are ≥12 years of age and satisfy at least one of the following risk factors at the time of screening Are ≥65 years of age
Are adults (≥18 years of age) with BMI >25 kg/m2 , or if age 12-17, have BMI ≥85th percentile for their age and gender based on CDC growth charts
Have chronic kidney disease
Have type 1 or type 2 diabetes
Have immunosuppressive disease
Are currently receiving immunosuppressive treatment
Have cardiovascular disease (including congenital heart disease) or hypertension
Have chronic lung diseases (for example, chronic obstructive pulmonary disease, asthma [moderate-to-severe], interstitial lung disease, cystic fibrosis and pulmonary hypertension)
Have sickle cell disease
Have neurodevelopmental disorder (for example, cerebral palsy) or other conditions that confer medical complexity (for example, genetic or metabolic syndromes and severe congenital anomalies)
Have a medical-related technological dependence (for example, tracheostomy, gastrostomy, or positive pressure ventilation [not related to COVID-19]
Are currently not hospitalized
Have one or more mild or moderate COVID-19 symptoms: Fever, cough, sore throat, malaise, headache, muscle pain, gastrointestinal symptoms, or shortness of breath with exertion, nasal congestion or runny nose, new loss of smell, chills
Must have sample taken for test confirming viral infection no more than 3 days prior to starting the drug infusion
Are men or non-pregnant women who agree to contraceptive requirements
Understand and agree to comply with planned study procedures
Agree to the collection of nasopharyngeal swabs and venous blood
The participant or legally authorized representative give signed informed consent and/or assent
Exclusion Criteria:
For low-risk participants only: BMI ≥35
Have oxygen saturation (SpO2) less than or equal to (≤)93 percent (%) on room air at sea level or ratio of arterial oxygen partial pressure (PaO2 in millimeters of mercury) to fractional inspired oxygen (FiO2) <300, respiratory rate ≥30 per minute, heart rate ≥125 per minute
Require mechanical ventilation or anticipated impending need for mechanical ventilation
Have known allergies to any of the components used in the formulation of the interventions
Have hemodynamic instability requiring use of pressors within 24 hours of randomization
Suspected or proven serious, active bacterial, fungal, viral, or other infection (besides COVID-19) that in the opinion of the investigator could constitute a risk when taking intervention
Have any co-morbidity requiring surgery within <7 days, or that is considered life-threatening within 29 days
Have any serious concomitant systemic disease, condition or disorder that, in the opinion of the investigator, should preclude participation in this study
Have a history of a positive severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) test prior to the one serving as eligibility for this study
Have received an investigational intervention for SARS-CoV-2 prophylaxis within 30 days before dosing
Have received treatment with a SARS-CoV-2 specific monoclonal antibody
Have a history of convalescent COVID-19 plasma treatment
For low-risk arms only: have received a SARS-CoV-2 vaccine or have participated in a previous SARS-CoV-2 vaccine study and are currently blinded to treatment allotment
Have participated, within the last 30 days, in a clinical study involving an investigational intervention. If the previous investigational intervention has a long half-life, 5 half-lives or 30 days, whichever is longer, should have passed
Are concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study
Are pregnant or breast feeding
Are investigator site personnel directly affiliated with this study
Have body weight <40 kilograms
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
12 Years
Maximum Age
Not provided
Standard Ages
ChildAdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
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)
Nichols RM, Macpherson L, Patel DR, Yeh WW, Peppercorn A. Effect of Bamlanivimab as Monotherapy or in Combination with Etesevimab or Sotrovimab on Persistently High Viral Load in Patients with Mild-to-Moderate COVID-19: A Randomized, Phase 2 BLAZE-4 Trial. Infect Dis Ther. 2024 Feb;13(2):401-411. doi: 10.1007/s40121-024-00918-1. Epub 2024 Jan 30.
Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.
Access Criteria
Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
Percentage of participants with SARS-CoV-2 viral load greater than 5.27 on Day 7. Missing data is estimated using Last Observation Carried Forward (LOCF).
Day 7
Addendum (2): Percentage of Participants With SARS-CoV-2 Viral Load Greater Than 5.27
Missing data is estimated using Relevance Sequence Imputation (RSI). RSI is defined as follows: If Day 7 SARS-CoV-2 viral load is missing, then Day 7 will be imputed using data from the first available for Day 5, Day 3, Day 11, or Day 1.
Day 7
Addendum (4), Arm A - Intravenous: Percentage of Participants With SARS-CoV-2 Viral Load Greater Than 5.27
Percentage of participants with SARS-CoV-2 viral load greater than 5.27 on Day 7. Missing data is estimated using Last Observation Carried Forward (LOCF).
Day 7
Addendum (4) Arm B - Subcutaneous: Percentage of Participants With SARS-CoV-2 Viral Load Greater Than 5.27
Percentage of participants with SARS-CoV-2 viral load greater than 5.27 on Day 7. Missing data is estimated using Last Observation Carried Forward (LOCF).
Day 7
Treatment 1-6 and Unintentional Dosing Arms: Percentage of Participants Who Experience COVID-19 Related Hospitalization or Death From Any Cause
Percentage of Participants Who Experience COVID-19 Related Hospitalization or Death from any Cause
Baseline through Day 29
Treatment 7-8, Amendment (C-E): Percentage of Participants Who Experience COVID-19 Related Hospitalization or Death From Any Cause
Percentage of Participants Who Experience COVID-19 Related Hospitalization or Death from Any Cause
Baseline through Day 29
Treatment 9-11 Amendment (f), Low Risk Participants: Percentage of Participants Who Experience COVID-19 Related Hospitalization or Death From Any Cause
Percentage of Participants Who Experience COVID-19 Related Hospitalization or Death From Any Cause
Baseline through Day 29
Treatment 12 -13 Amendment (f), High Risk Participants: Percentage of Participants Who Experience COVID-19 Related Hospitalization or Death From Any Cause
Percentage of Participants Who Experience COVID-19 Related Hospitalization or Death From Any Cause
Baseline through Day 29
Treatment 14 Amendment (f) High Risk Participants, Updated CDC Criteria: Percentage of Participants Who Experience COVID-19 Related Hospitalization or Death From Any Cause
Percentage of Participants Who Experience COVID-19 Related Hospitalization or Death From Any Cause
Baseline through Day 29
Treatment 1-6 and Unintentional Dosing Arms: Change From Baseline to Day 7 in SARS-CoV-2 Viral Load
Least squares mean (LSM) change from baseline was calculated using a mixed model repeating measures (MMRM) that included log base 10 transformed baseline as a covariate, treatment, day, treatment-by-day interaction as fixed effects. Viral load is reported as normalized viral and is unitless.
Baseline, Day 7
Treatment 7-8 Amendments (C-e): Change From Baseline to Day 7 in SARS-CoV-2 Viral Load
LSM change from baseline was calculated using a MMRM that included log base 10 transformed baseline as a covariate, treatment, day, treatment-by-day interaction as fixed effects. Viral load is reported as normalized viral and is unitless.
Baseline, Day 7
Treatment 9-11 Amendment (f), Low Risk Participants: Change From Baseline to Day 7 in SARS-CoV-2 Viral Load
LSM change from baseline was calculated using a MMRM that included log base 10 transformed baseline as a covariate, treatment, day, treatment-by-day interaction as fixed effects. Viral load is reported as normalized viral and is unitless.
Baseline, Day 7
Treatment 12 -13 Amendment (f), High Risk Participants: Change From Baseline to Day 7 in SARS-CoV-2 Viral Load
Baseline is defined as the last non-missing assessment recorded on or prior to the date of first study drug injection. Viral load is reported as normalized viral and is unitless.
Baseline, Day 7
Treatment 14, Amendment (f) High Risk Participants Updated CDC Criteria: Change From Baseline to Day 7 in SARS-CoV-2 Viral Load
Baseline is defined as the last non-missing assessment recorded on or prior to the date of first study drug injection. Viral load is reported as normalized viral and is unitless.
Baseline, Day 7
Addendum 4, IV: Change From Baseline to Day 7 in SARS-CoV-2 Viral Load
Baseline is defined as the last non-missing assessment recorded on or prior to the date of first study drug injection. Viral load is reported as normalized viral and is unitless.
Baseline, Day 7
Addendum 4, SC: Change From Baseline to Day 7 in SARS-CoV-2 Viral Load
Baseline is defined as the last non-missing assessment recorded on or prior to the date of first study drug injection. Viral load is reported as normalized viral and is unitless.
Baseline, Day 7
Addendum (2): Change From Baseline to Day 7 in SARS-CoV-2 Viral Load
Baseline is defined as the last non-missing assessment recorded on or prior to the date of first study drug injection. Viral load is reported as normalized viral and is unitless.
Baseline, Day 7
Treatment 1-6 and Unintentional Dosing Arms: Percentage of Participants Demonstrating Symptom Resolution
Symptoms associated with COVID-19 were evaluated using a questionnaire that contains the following symptoms: cough, shortness of breath, feeling feverish, fatigue, body aches and pain, sore throat, chills, headache, loss of appetite, and loss in taste and smell. Each symptom (excluding loss of taste and smell) was scored daily by the participant as experienced during the past 24 hours with following rating and score: None or absent (0), Mild (1), Moderate (2) and Severe (3). Loss of taste and smell was scored as Yes (Y) or No (N). Symptom resolution (yes/no) is defined as all symptoms (excluding loss of appetite, taste, and smell) on the symptom questionnaire scored as absent (score of 0). Missing data was imputed using a non-responder imputation.
Day 7
Treatment 7-8 Amendments (C-e): Percentage of Participants Demonstrating Symptom Resolution
Symptoms associated with COVID-19 were evaluated using a questionnaire that contains the following symptoms: cough, shortness of breath, feeling feverish, fatigue, body aches and pain, sore throat, chills, headache, loss of appetite, and loss in taste and smell. Each symptom (excluding loss of taste and smell) was scored daily by the participant as experienced during the past 24 hours with following rating and score: None or absent (0), Mild (1), Moderate (2) and Severe (3). Loss of taste and smell was scored as Yes (Y) or No (N). Symptom resolution (yes/no) is defined as all symptoms (excluding loss of appetite, taste, and smell) on the symptom questionnaire scored as absent (score of 0). Missing data was imputed using a non-responder imputation.
Symptoms associated with COVID-19 were evaluated using a questionnaire that contains the following symptoms: cough, shortness of breath, feeling feverish, fatigue, body aches and pain, sore throat, chills, headache, loss of appetite, and loss in taste and smell. Each symptom (excluding loss of taste and smell) was scored daily by the participant as experienced during the past 24 hours with following rating and score: None or absent (0), Mild (1), Moderate (2) and Severe (3). Loss of taste and smell was scored as Yes (Y) or No (N). Symptom resolution (yes/no) is defined as a score of 0 for shortness of breath, feeling feverish, body aches and pains, sore throat, chills, and headache, and a score of 0 or 1 for cough and fatigue on the symptom questionnaire. Missing data was imputed using a non-responder imputation.
Day 7
Treatment 12 -13 Amendment (f), High Risk Participants: Percentage of Participants Demonstrating Symptom Resolution
Symptoms associated with COVID-19 were evaluated using a questionnaire that contains the following symptoms: cough, shortness of breath, feeling feverish, fatigue, body aches and pain, sore throat, chills, headache, loss of appetite, and loss in taste and smell. Each symptom (excluding loss of taste and smell) was scored daily by the participant as experienced during the past 24 hours with following rating and score: None or absent (0), Mild (1), Moderate (2) and Severe (3). Loss of taste and smell was scored as Yes (Y) or No (N). Symptom resolution (yes/no) is defined as a score of 0 for shortness of breath, feeling feverish, body aches and pains, sore throat, chills, and headache, and a score of 0 or 1 for cough and fatigue on the symptom questionnaire. Missing data was imputed using a non-responder imputation.
Day 7
Treatment 14, Amendment (g) High Risk Participants Updated CDC Criteria Amendment (g): Percentage of Participants Demonstrating Symptom Resolution
Symptoms associated with COVID-19 were evaluated using a questionnaire that contains the following symptoms: cough, shortness of breath, feeling feverish, fatigue, body aches and pain, sore throat, chills, headache, loss of appetite, and loss in taste and smell. Each symptom (excluding loss of taste and smell) was scored daily by the participant as experienced during the past 24 hours with following rating and score: None or absent (0), Mild (1), Moderate (2) and Severe (3). Loss of taste and smell was scored as Yes (Y) or No (N). Symptom resolution (yes/no) is defined as a score of 0 for shortness of breath, feeling feverish, body aches and pains, sore throat, chills, and headache, and a score of 0 or 1 for cough and fatigue on the symptom questionnaire. Missing data was imputed using a non-responder imputation.
Day 7
Treatment 1-6 and Unintentional Dosing Arms: Percentage of Participants Demonstrating Symptom Improvement
Symptoms associated with COVID-19 were evaluated using a questionnaire that contains the following symptoms: cough, shortness of breath, feeling feverish, fatigue, body aches and pain, sore throat, chills, headache, loss of appetite, and loss in taste and smell. Each symptom (excluding loss of taste and smell) was scored daily by the participant as experienced during the past 24 hours with following rating and score: None or absent (0), Mild (1), Moderate (2) and Severe (3). Loss of taste and smell was scored as Yes (Y) or No (N). Symptom improvement (yes/no) is defined as a patient experiencing symptoms on the symptom questionnaire (excluding loss of appetite, taste, and smell) scored as moderate or severe (score of 2 or 3) at baseline are subsequently scored as mild or absent (score of 1 or 0), AND symptoms on the symptom questionnaire scored as mild or absent at baseline are subsequently scored as absent.
Day 7
Treatment 7-8 Amendments (C-E): Percentage of Participants Demonstrating Symptom Improvement
Symptoms associated with COVID-19 were evaluated using a questionnaire that contains the following symptoms: cough, shortness of breath, feeling feverish, fatigue, body aches and pain, sore throat, chills, headache, loss of appetite, and loss in taste and smell. Each symptom (excluding loss of taste and smell) was scored daily by the participant as experienced during the past 24 hours with following rating and score: None or absent (0), Mild (1), Moderate (2) and Severe (3). Loss of taste and smell was scored as Yes (Y) or No (N). Symptom improvement (yes/no) is defined as a patient experiencing symptoms on the symptom questionnaire (excluding loss of appetite, taste, and smell) scored as moderate or severe (score of 2 or 3) at baseline are subsequently scored as mild or absent (score of 1 or 0), AND symptoms on the symptom questionnaire scored as mild or absent at baseline are subsequently scored as absent.
Symptoms associated with COVID-19 were evaluated using a questionnaire that contains the following symptoms: cough, shortness of breath, feeling feverish, fatigue, body aches and pain, sore throat, chills, headache, loss of appetite, and loss in taste and smell. Each symptom (excluding loss of taste and smell) was scored daily by the participant as experienced during the past 24 hours with following rating and score: None or absent (0), Mild (1), Moderate (2) and Severe (3). Loss of taste and smell was scored as Yes (Y) or No (N). Symptom improvement (yes/no) is defined as a patient experiencing symptoms on the symptom questionnaire (excluding loss of appetite, taste, and smell) scored as moderate or severe (score of 2 or 3) at baseline are subsequently scored as mild or absent (score of 1 or 0), AND symptoms on the symptom questionnaire scored as mild or absent at baseline are subsequently scored as absent.
Day 7
Treatment 12 -13 Amendment (f), High Risk Participants: Percentage of Participants Demonstrating Symptom Improvement
Symptoms associated with COVID-19 were evaluated using a questionnaire that contains the following symptoms: cough, shortness of breath, feeling feverish, fatigue, body aches and pain, sore throat, chills, headache, loss of appetite, and loss in taste and smell. Each symptom (excluding loss of taste and smell) was scored daily by the participant as experienced during the past 24 hours with following rating and score: None or absent (0), Mild (1), Moderate (2) and Severe (3). Loss of taste and smell was scored as Yes (Y) or No (N). Symptom improvement (yes/no) is defined as a patient experiencing symptoms on the symptom questionnaire (excluding loss of appetite, taste, and smell) scored as moderate or severe (score of 2 or 3) at baseline are subsequently scored as mild or absent (score of 1 or 0), AND symptoms on the symptom questionnaire scored as mild or absent at baseline are subsequently scored as absent.
Day 7
Treatment 14 Amendment (g): Percentage of Participants Demonstrating Symptom Improvement
Symptoms associated with COVID-19 were evaluated using a questionnaire that contains the following symptoms: cough, shortness of breath, feeling feverish, fatigue, body aches and pain, sore throat, chills, headache, loss of appetite, and loss in taste and smell. Each symptom (excluding loss of taste and smell) was scored daily by the participant as experienced during the past 24 hours with following rating and score: None or absent (0), Mild (1), Moderate (2) and Severe (3). Loss of taste and smell was scored as Yes (Y) or No (N). Symptom improvement (yes/no) is defined as a patient experiencing symptoms on the symptom questionnaire (excluding loss of appetite, taste, and smell) scored as moderate or severe (score of 2 or 3) at baseline are subsequently scored as mild or absent (score of 1 or 0), AND symptoms on the symptom questionnaire scored as mild or absent at baseline are subsequently scored as absent.
Day 7
Treatment 1-6 and Unintentional Dosing Arms: Percentage of Participants Who Experience COVID-19 Related Hospitalization, COVID-19 Related Emergency Room Visit, or Death From Any Cause
Percentage of Participants Who Experience COVID-19 Related Hospitalization, COVID-19 Related Emergency Room Visit, or Death From Any Cause
Baseline through Day 29
Treatment 7-8 Amendments (C-E): Percentage of Participants Who Experience COVID-19 Related Hospitalization, COVID-19 Related Emergency Room Visit, or Death From Any Cause
Percentage of Participants Who Experience COVID-19 Related Hospitalization, COVID-19 Related Emergency Room Visit, or Death From Any Cause
Baseline through Day 29
Treatment 9-11 Amendment (f), Low Risk Participants: Percentage of Participants Who Experience COVID-19 Related Hospitalization, COVID-19 Related Emergency Room Visit, or Death From Any Cause
Percentage of Participants Who Experience COVID-19 Related Hospitalization, COVID-19 Related Emergency Room Visit, or Death From Any Cause
Baseline through Day 29
Treatment 12 -13 Amendment (f), High Risk Participants: Percentage of Participants Who Experience COVID-19 Related Hospitalization, COVID-19 Related Emergency Room Visit, or Death From Any Cause
Percentage of Participants Who Experience COVID-19 Related Hospitalization, COVID-19 Related Emergency Room Visit, or Death From Any Cause
Baseline through Day 29
Treatment 14 Amendment (g): Percentage of Participants Who Experience COVID-19 Related Hospitalization, COVID-19 Related Emergency Room Visit, or Death From Any Cause
Percentage of Participants Who Experience COVID-19 Related Hospitalization, COVID-19 Related Emergency Room Visit, or Death From Any Cause
Baseline through Day 29
Pharmacokinetics (PK): Mean Concentration of Bamlanivimab
PK: Mean Concentration of Bamlanivimab
Day 29
Pharmacokinetics (PK): Mean Concentration of Etesevimab
Pharmacokinetics (PK): Mean Concentration of Etesevimab
Day 29
Pharmacokinetics (PK): Mean Concentration of Bebtelovimab
Pharmacokinetics (PK): Mean Concentration of Bebtelovimab
Day 29
Pharmacokinetics (PK): Mean Concentration of VIR-7831
PK: Mean Concentration of VIR-7831
Day 29
Mesa
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United States
Perseverance Research Center
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CRI of Arizona, LLC
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Central Valley Research, LLC
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Inland Empire Liver Foundation
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Sutter Institute For Medical Research
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Wolverine Clinical Trials, LLC
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St. Joe Heritage HC-Santa Rosa
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Stanford University Hospital
Stanford
California
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Mazur, Statner, Dutta, Nathan
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California
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South Bay Clinical Research Institute
Torrance
California
90503
United States
Infect Disease Doctors Med Grp
Walnut Creek
California
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United States
Allianz Research Institute
Westminster
California
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Future Innovative Treatments LLC
Colorado Springs
Colorado
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Georgetown Univ Sch of Med
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District of Columbia
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Synergy Healthcare LLC
Bradenton
Florida
34208
United States
Holy Cross Hospital Inc.
Fort Lauderdale
Florida
33308
United States
I R & Health Center, Inc.
Hialeah
Florida
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Florida
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Elixia CRC
Hollywood
Florida
33023
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Lakeland Regional Medical Center
Lakeland
Florida
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United States
Hope Clinical Trials, Inc.
Miami
Florida
33165
United States
Miami Cancer Institute at Baptist Health, Inc.
Miami
Florida
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United States
Bio-Medical Research, LLC
Miami
Florida
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United States
Clinical Site Partners, LLC d/b/a CSP Miami
Miami
Florida
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United States
Panax Clinical Research
Miami Lakes
Florida
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Testing Matters Lab
Sunrise
Florida
33325
United States
Advent Health Tampa
Tampa
Florida
33613
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Triple O Research Inst
West Palm Beach
Florida
33407
United States
Encore Medical Research - Weston
Weston
Florida
33331
United States
Clinical Site Partners, LLC DBA CSP Orlando
Winter Park
Florida
32789
United States
Gwinnett Research Inst
Buford
Georgia
30519
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Paramount Rch Sol - College Pk
College Park
Georgia
30349
United States
IACT Health - VHC
Columbus
Georgia
31904
United States
Central Georgia Infectious Disease
Macon
Georgia
31201
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Rophe Adult and Pediatric Medicine
Union City
Georgia
30291
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Rocky Mountain Clinical Research
Idaho Falls
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United States
Ann & Robert H Lurie Children's Hospital of Chicago
Nathan R, Shawa I, De La Torre I, Pustizzi JM, Haustrup N, Patel DR, Huhn G. A Narrative Review of the Clinical Practicalities of Bamlanivimab and Etesevimab Antibody Therapies for SARS-CoV-2. Infect Dis Ther. 2021 Dec;10(4):1933-1947. doi: 10.1007/s40121-021-00515-6. Epub 2021 Aug 10.
FG002
Treatment 3: 700 mg BAM +1400 mg ETE
Participants received 700 mg BAM +1400 mg ETE administered IV.
FG003
Treatment 4: 2800 mg BAM +2800 mg ETE
Participants received 2800 mg BAM + 2800 mg ETE administered IV.
FG004
Treatment 5: 700 mg BAM
Participants received 700 mg BAM administered IV.
FG005
Treatment 6: 350 mg BAM +700 mg ETE
Participants received 350 mg BAM +700 mg ETE administered IV.
FG006
Unintentional Dosing: 700 mg BAM +700 mg ETE
Participants received 700 mg BAM +700 mg ETE administered IV.
Participants received 175 mg BAM + 700 mg ETE + 1400 mg BEB 350 mg/min IV.
FG023
1750 mg BEB 350 mg/Min (Addendum 4, IV)
Participants received 1750 mg BEB 350 mg/min IV.
FG024
Pooled Placebo (Addendum 4, SC)
Participants received Placebo SC.
FG025
280 mg BEB (Addendum 4, SC)
Participants received 280 mg BEB SC.
FG026
560 mg BEB (Addendum 4, SC)
Participants received 560 mg BEB SC.
FG000155 subjects
FG00183 subjects
FG002158 subjects
FG003103 subjects
FG004105 subjects
FG005101 subjects
FG00620 subjectsDuring the study period, 20 participants from the BAM 175-mg + ETE 350-mg arm potentially received 700 mg bamlanivimab + 700 mg etesevimab instead. These 20 participants, who were randomized at 8 different sites were identified through pharmacokinetics analyses.
FG007101 subjects
FG008101 subjects
FG009125 subjects
FG010127 subjects
FG011128 subjects
FG012100 subjects
FG01350 subjects
FG014176 subjects
FG01530 subjects
FG0166 subjects
FG01730 subjects
FG01810 subjects
FG0196 subjects
FG0206 subjects
FG0216 subjects
FG0226 subjects
FG0236 subjects
FG0244 subjects
FG0256 subjects
FG0266 subjects
Received at Least One Dose of Study Drug
FG000155 subjects
FG00183 subjects
FG002158 subjects
FG003103 subjects
FG004105 subjects
FG005101 subjects
FG00620 subjects
FG007101 subjects
FG008101 subjects
FG009125 subjects
FG010127 subjects
FG011128 subjects
FG012100 subjects
FG01350 subjects
FG014176 subjects
FG01530 subjects
FG0166 subjects
FG01730 subjects
FG01810 subjects
FG0196 subjects
FG0206 subjects
FG0216 subjects
FG0226 subjects
FG0236 subjects
FG0244 subjects
FG0256 subjects
FG0266 subjects
COMPLETED
FG000148 subjects
FG00181 subjects
FG002150 subjects
FG00396 subjects
FG004102 subjects
FG00599 subjects
FG00619 subjects
FG00790 subjects
FG00891 subjects
FG009112 subjects
FG010114 subjects
FG011109 subjects
FG01292 subjects
FG01346 subjects
FG014164 subjects
FG01530 subjects
FG0166 subjects
FG01729 subjects
FG01810 subjects
FG0196 subjects
FG0206 subjects
FG0216 subjects
FG0226 subjects
FG0235 subjects
FG0244 subjects
FG0256 subjects
FG0266 subjects
NOT COMPLETED
FG0007 subjects
FG0012 subjects
FG0028 subjects
FG0037 subjects
FG0043 subjects
FG0052 subjects
FG0061 subjects
FG00711 subjects
FG00810 subjects
FG00913 subjects
FG01013 subjects
FG01119 subjects
FG0128 subjects
FG0134 subjects
FG01412 subjects
FG0150 subjects
FG0160 subjects
FG0171 subjects
FG0180 subjects
FG0190 subjects
FG0200 subjects
FG0210 subjects
FG0220 subjects
FG0231 subjects
FG0240 subjects
FG0250 subjects
FG0260 subjects
Type
Comment
Reasons
Death
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0101 subjects
FG0110 subjects
FG0121 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
FG0170 subjects
FG0180 subjects
FG0190 subjects
FG0200 subjects
FG0210 subjects
FG0220 subjects
FG0230 subjects
FG0240 subjects
FG0250 subjects
FG0260 subjects
Adverse Event
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
Lost to Follow-up
FG0003 subjects
FG0011 subjects
FG0021 subjects
FG0033 subjects
FG004
Withdrawal by Subject
FG0003 subjects
FG0011 subjects
FG0026 subjects
FG0034 subjects
FG004
Other - As reported by Investigator
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
All participants who received at least one dose of study drug.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Treatment 1: Pbo
Participants received placebo (Pbo) administered intravenously (IV).
BG001
Treatment 2: 175 mg BAM +350 mg ETE
Participants received 175 milligrams (mg) bamlanivimab (BAM) +350 mg etesevimab (ETE) administered IV.
BG002
Treatment 3: 700 mg BAM +1400 mg ETE
Participants received 700 mg BAM +1400 mg ETE administered IV.
BG003
Treatment 4: 2800 mg BAM +2800 mg ETE
Participants received 2800 mg BAM + 2800 mg ETE administered IV.
BG004
Treatment 5: 700 mg BAM
Participants received 700 mg BAM administered IV.
BG005
Treatment 6: 350 mg BAM +700 mg ETE
Participants received 350 mg BAM +700 mg ETE administered IV.
Participants received 175 mg BAM + 700 mg ETE + 1400 mg BEB 350 mg/min IV.
BG023
1750 mg BEB 350 mg/Min (Addendum 4, IV)
Participants received 1750 mg BEB 350 mg/min IV.
BG024
Pooled Placebo (Addendum 4, SC)
Participants received Placebo SC.
BG025
280 BEB (Addendum 4, SC)
Participants received 280 mg BEB SC.
BG026
560 mg BEB (Addendum 4, SC)
Participants received 560 mg BEB SC.
BG027
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG000155
BG00183
BG002158
BG003103
BG004105
BG005101
BG00620
BG007101
BG008101
BG009125
BG010127
BG011128
BG012100
BG01350
BG014176
BG01530
BG0166
BG01730
BG01810
BG0196
BG0206
BG0216
BG0226
BG0236
BG0244
BG0256
BG0266
BG0271755
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00038.9± 12.22
BG00141.5± 12.89
BG00237.7± 12.11
BG003
Sex: Female, Male
Count of Participants
Participants
No
Title
Denominators
Categories
Title
Measurements
Female
BG00075
BG00139
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
No
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG00048
BG00124
BG002
Race (NIH/OMB)
Count of Participants
Participants
No
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0002
BG0010
BG002
Region of Enrollment
Count of Participants
Participants
No
Title
Denominators
Categories
United States
Title
Measurements
BG000155
BG00183
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Treatment 1-6 and Unintentional Dosing Arms: Percentage of Participants With Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Viral Load Greater Than 5.27
Percentage of participants with SARS-CoV-2 viral load greater than 5.27 on Day 7. Missing data is estimated using Relevance Sequence Imputation (RSI). RSI is defined as follows: If Day 7 SARS-CoV-2 viral load is missing, then Day 7 will be imputed using data from the first available for Day 5, Day 3, Day 11, or Day 1.
Treatment 1-6 and Unintentional Dosing arms: All randomized participants who received study drug and provided at least 1 postbaseline measure viral load measurement.
Posted
Number
95% Confidence Interval
percentage of participants
Day 7
ID
Title
Description
OG000
Treatment 1: Pbo
Participants received placebo (Pbo) administered intravenously (IV).
OG001
Treatment 2: 175 mg BAM +350 mg ETE
Participants received 175 milligrams (mg) bamlanivimab (BAM) +350 mg etesevimab (ETE) administered IV.
OG002
Treatment 3: 700 mg BAM +1400 mg ETE
Participants received 700 mg BAM +1400 mg ETE administered IV.
OG003
Treatment 4: 2800 mg BAM +2800 mg ETE
Participants received 2800 mg BAM + 2800 mg ETE administered IV.
OG004
Treatment 5: 700 mg BAM
Participants received 700 mg BAM administered IV.
OG005
Treatment 6: 350 mg BAM +700 mg ETE
Participants received 350 mg BAM +700 mg ETE administered IV.
OG006
Unintentional Dosing: 700 mg BAM +700 mg ETE
Participants received 700 mg BAM +700 mg ETE administered IV.
Units
Counts
Participants
OG000155
OG00182
OG002157
OG003
Title
Denominators
Categories
Title
Measurements
OG00027.7(20.7 to 34.8)
OG00112.2(5.1 to 19.3)
OG00210.8(6.0 to 15.7)
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Regression, Logistic
0.009273
Odds Ratio (OR)
0.37
2-Sided
95
0.18
0.78
Superiority
OG000
OG002
Regression, Logistic
0.000271
Primary
Treatment 7-8, Amendments (C-e): Percentage of Participants With SARS-CoV-2 Viral Load Greater Than 5.27
Percentage of participants with SARS-CoV-2 viral load greater than 5.27 on Day 7. Missing data is estimated using Last Observation Carried Forward (LOCF).
Treatment 7-8, Amendments (C-e): All randomized participants who received study drug and provided at least 1 postbaseline measure viral load measurement.
Treatment 9-11 Amendment (f), Low Risk Participants: Percentage of Participants With SARS-CoV-2 Viral Load Greater Than 5.27
Percentage of participants with SARS-CoV-2 viral load greater than 5.27 on Day 7. Missing data is estimated using Last Observation Carried Forward (LOCF).
Treatment 9-11 Amendment (f), Low Risk Participants: All randomized participants who received study drug and provided at least 1 postbaseline measure viral load measurement.
Treatment 12 -13, Amendment (f) High Risk Participants: Percentage of Participants With SARS-CoV-2 Viral Load Greater Than 5.27
Percentage of participants with SARS-CoV-2 viral load greater than 5.27 on Day 7. Missing data is estimated using Last Observation Carried Forward (LOCF).
Treatment 12 -13, Amendment (f) High Risk Participants: All randomized participants who received study drug and provided at least 1 postbaseline measure viral load measurement.
Posted
Number
95% Confidence Interval
percentage of participants
Day 7
ID
Title
Description
OG000
Treatment 12: 175 mg BEB (Amendment (f), High Risk Participants)
Participants received 700 mg BAM +1400 mg ETE + 175 mg BEB administered IV.
Units
Counts
Participants
Secondary
Treatment 14, Amendment (f) High Risk Participants Updated CDC Criteria: Percentage of Participants With SARS-CoV-2 Viral Load Greater Than 5.27
Percentage of participants with SARS-CoV-2 viral load greater than 5.27 on Day 7. Missing data is estimated using Last Observation Carried Forward (LOCF).
Treatment 14, Amendment (f) High Risk Participants Updated CDC Criteria: All randomized participants who received study drug and provided at least 1 postbaseline measure viral load measurement.
Participants received 700 mg BAM +1400 mg ETE + 175 mg BEB administered IV for participants in updated CDC criteria.
Units
Counts
Participants
OG000
Secondary
Addendum (2): Percentage of Participants With SARS-CoV-2 Viral Load Greater Than 5.27
Missing data is estimated using Relevance Sequence Imputation (RSI). RSI is defined as follows: If Day 7 SARS-CoV-2 viral load is missing, then Day 7 will be imputed using data from the first available for Day 5, Day 3, Day 11, or Day 1.
Addendum (2): All randomized participants who received study drug and provided at least 1 postbaseline measure viral load measurement.
Posted
Number
95% Confidence Interval
percentage of participants
Day 7
ID
Title
Description
OG000
700 mg BAM 15-min (Addendum (2))
Participants received 700 mg BAM administered IV.
Addendum 2 explored the safety of accelerated intravenous (IV) administration of BAM alone and in combination with ETE.
OG001
700 mg BAM + 1400 mg ETE 30-min (Addendum (2))
Participants received 700 mg BAM +1400 mg ETE administered IV.
Addendum 2 explored the safety of accelerated intravenous (IV) administration of BAM alone and in combination with ETE.
OG002
700 mg BAM + 1400 mg ETE 15-min (Addendum (2))
Participants received 700 mg BAM +1400 mg ETE administered IV.
Addendum 2 explored the safety of accelerated intravenous (IV) administration of BAM alone and in combination with ETE.
Secondary
Addendum (4), Arm A - Intravenous: Percentage of Participants With SARS-CoV-2 Viral Load Greater Than 5.27
Percentage of participants with SARS-CoV-2 viral load greater than 5.27 on Day 7. Missing data is estimated using Last Observation Carried Forward (LOCF).
Addendum (4) Arm A - Intravenous: All randomized participants who received study drug and provided at least 1 postbaseline measure viral load measurement.
Posted
Number
95% Confidence Interval
percentage of participants
Day 7
ID
Title
Description
OG000
Pooled Placebo (Addendum 4, IV)
Participants received placebo administered IV.
OG001
70 mg BEB 140 mg/Min (Addendum 4, IV)
Participants received 70 mg BEB 140 mg/min IV.
OG002
175 BEB 140 mg/Min (Addendum 4, IV)
Participants received 175 mg BEB 140 mg/min IV.
OG003
175 BEB 350 mg/Min (Addendum 4, IV)
Participants received 175 mg BEB 350 mg/min IV.
Secondary
Addendum (4) Arm B - Subcutaneous: Percentage of Participants With SARS-CoV-2 Viral Load Greater Than 5.27
Percentage of participants with SARS-CoV-2 viral load greater than 5.27 on Day 7. Missing data is estimated using Last Observation Carried Forward (LOCF).
Addendum (4) Arm B - Subcutaneous: All randomized participants who received study drug and provided at least 1 postbaseline measure viral load measurement.
Posted
Number
95% Confidence Interval
percentage of participants
Day 7
ID
Title
Description
OG000
Pooled Placebo (Addendum 4, SC)
Participants received placebo administered SC.
OG001
280 mg BEB (Addendum 4, SC)
Participants received 280 mg BEB SC.
OG002
560 mg BEB (Addendum 4, SC)
Participants received 560 mg BEB SC.
Units
Counts
Participants
Secondary
Treatment 1-6 and Unintentional Dosing Arms: Percentage of Participants Who Experience COVID-19 Related Hospitalization or Death From Any Cause
Percentage of Participants Who Experience COVID-19 Related Hospitalization or Death from any Cause
Treatment 1-6 and Unintentional Dosing arms: All participants randomly assigned and who received any amount of study drug.
Posted
Number
95% Confidence Interval
percentage of participants
Baseline through Day 29
ID
Title
Description
OG000
Treatment 1: Pbo
Participants received placebo (Pbo) administered intravenously (IV).
OG001
Treatment 2: 175 mg BAM +350 mg ETE
Participants received 175 milligrams (mg) bamlanivimab (BAM) +350 mg etesevimab (ETE) administered IV.
OG002
Treatment 3: 700 mg BAM +1400 mg ETE
Participants received 700 mg BAM +1400 mg ETE administered IV.
OG003
Treatment 4: 2800 mg BAM +2800 mg ETE
Participants received 2800 mg BAM + 2800 mg ETE administered IV.
Secondary
Treatment 7-8, Amendment (C-E): Percentage of Participants Who Experience COVID-19 Related Hospitalization or Death From Any Cause
Percentage of Participants Who Experience COVID-19 Related Hospitalization or Death from Any Cause
Treatment 7-8, Amendment (C-E): All participants randomly assigned and who received any amount of study drug. No participants met the criteria (duration had to be 24 or more, and had to occur on Day 29 or before)
Treatment 9-11 Amendment (f), Low Risk Participants: Percentage of Participants Who Experience COVID-19 Related Hospitalization or Death From Any Cause
Percentage of Participants Who Experience COVID-19 Related Hospitalization or Death From Any Cause
Treatment 9-11 Amendment (f), Low Risk Participants: All randomized participants who received at least one dose of study drug.
Treatment 12 -13 Amendment (f), High Risk Participants: Percentage of Participants Who Experience COVID-19 Related Hospitalization or Death From Any Cause
Percentage of Participants Who Experience COVID-19 Related Hospitalization or Death From Any Cause
Treatment 12 -13 Amendment (f), High Risk Participants: All randomized participants who received at least one dose of study drug.
Posted
Number
95% Confidence Interval
percentage of participants
Baseline through Day 29
ID
Title
Description
OG000
Treatment 12: 175 mg BEB (Amendment (f), High Risk Participants
Participants received 700 mg BAM +1400 mg ETE + 175 mg BEB administered IV.
Units
Counts
Participants
OG000
Secondary
Treatment 14 Amendment (f) High Risk Participants, Updated CDC Criteria: Percentage of Participants Who Experience COVID-19 Related Hospitalization or Death From Any Cause
Percentage of Participants Who Experience COVID-19 Related Hospitalization or Death From Any Cause
Treatment 14 Amendment (f) High Risk, Participants Updated CDC Criteria: All randomized participants who received at least one dose of study drug.
Participants received 700 mg BAM +1400 mg ETE + 175 mg BEB administered IV for participants in updated CDC criteria.
Units
Counts
Participants
OG000
Secondary
Treatment 1-6 and Unintentional Dosing Arms: Change From Baseline to Day 7 in SARS-CoV-2 Viral Load
Least squares mean (LSM) change from baseline was calculated using a mixed model repeating measures (MMRM) that included log base 10 transformed baseline as a covariate, treatment, day, treatment-by-day interaction as fixed effects. Viral load is reported as normalized viral and is unitless.
Treatment 1-6 and Unintentional Dosing Arms: All randomized participants who received study drug and provided at least 1 postbaseline measure viral load measurement.
Posted
Least Squares Mean
Standard Error
unitless
Baseline, Day 7
ID
Title
Description
OG000
Treatment 1: Pbo
Participants received placebo (Pbo) administered intravenously (IV).
OG001
Treatment 2: 175 mg BAM +350 mg ETE
Participants received 175 milligrams (mg) bamlanivimab (BAM) +350 mg etesevimab (ETE) administered IV.
OG002
Treatment 3: 700 mg BAM +1400 mg ETE
Participants received 700 mg BAM +1400 mg ETE administered IV.
OG003
Treatment 4: 2800 mg BAM +2800 mg ETE
Secondary
Treatment 7-8 Amendments (C-e): Change From Baseline to Day 7 in SARS-CoV-2 Viral Load
LSM change from baseline was calculated using a MMRM that included log base 10 transformed baseline as a covariate, treatment, day, treatment-by-day interaction as fixed effects. Viral load is reported as normalized viral and is unitless.
Treatment 7-8 Amendments (c-e): All randomized participants who received study drug and provided at least 1 postbaseline measure viral load measurement.
Treatment 9-11 Amendment (f), Low Risk Participants: Change From Baseline to Day 7 in SARS-CoV-2 Viral Load
LSM change from baseline was calculated using a MMRM that included log base 10 transformed baseline as a covariate, treatment, day, treatment-by-day interaction as fixed effects. Viral load is reported as normalized viral and is unitless.
Treatment 9-11 Amendment (f), Low Risk Participants: All randomized participants who received study drug and provided at least 1 postbaseline measure viral load measurement.
Treatment 12 -13 Amendment (f), High Risk Participants: Change From Baseline to Day 7 in SARS-CoV-2 Viral Load
Baseline is defined as the last non-missing assessment recorded on or prior to the date of first study drug injection. Viral load is reported as normalized viral and is unitless.
Treatment 12 -13 Amendment (f), High Risk Participants: All randomized participants who received study drug and provided at least 1 postbaseline measure viral load measurement.
Posted
Mean
Standard Deviation
unitless
Baseline, Day 7
ID
Title
Description
OG000
Treatment 12: 175 mg BEB (Amendment (f), High Risk Participants)
Participants received 700 mg BAM +1400 mg ETE + 175 mg BEB administered IV.
Units
Counts
Participants
Secondary
Treatment 14, Amendment (f) High Risk Participants Updated CDC Criteria: Change From Baseline to Day 7 in SARS-CoV-2 Viral Load
Baseline is defined as the last non-missing assessment recorded on or prior to the date of first study drug injection. Viral load is reported as normalized viral and is unitless.
Treatment 14, Amendment (f) High Risk Participants Updated CDC Criteria: All randomized participants who received study drug and provided at least 1 postbaseline measure viral load measurement.
Participants received 700 mg BAM +1400 mg ETE + 175 mg BEB administered IV for participants in updated CDC criteria.
Units
Counts
Participants
OG000
Secondary
Addendum 4, IV: Change From Baseline to Day 7 in SARS-CoV-2 Viral Load
Baseline is defined as the last non-missing assessment recorded on or prior to the date of first study drug injection. Viral load is reported as normalized viral and is unitless.
Addendum 4, IV: All randomized participants who received study drug and provided at least 1 postbaseline measure viral load measurement.
Posted
Mean
Standard Deviation
unitless
Baseline, Day 7
ID
Title
Description
OG000
Pooled Placebo (Addendum 4, IV)
Participants received placebo administered IV.
OG001
70 mg BEB 140 mg/Min (Addendum 4, IV)
Participants received 70 mg BEB 140 mg/min IV.
OG002
175 BEB 140 mg/Min (Addendum 4, IV)
Participants received 175 mg BEB 140 mg/min IV.
OG003
175 BEB 350 mg/Min (Addendum 4, IV)
Participants received 175 mg BEB 350 mg/min IV.
OG004
Secondary
Addendum 4, SC: Change From Baseline to Day 7 in SARS-CoV-2 Viral Load
Baseline is defined as the last non-missing assessment recorded on or prior to the date of first study drug injection. Viral load is reported as normalized viral and is unitless.
Addendum 4, SC: All randomized participants who received study drug and provided at least 1 postbaseline measure viral load measurement.
Posted
Mean
Standard Deviation
unitless
Baseline, Day 7
ID
Title
Description
OG000
Pooled Placebo (Addendum 4, SC)
Participants received Placebo SC.
OG001
280 mg BEB (Addendum 4, SC)
Participants received 280 mg BEB SC.
OG002
560 mg BEB (Addendum 4, SC
Participants received 560 mg BEB SC.
Units
Counts
Participants
Secondary
Addendum (2): Change From Baseline to Day 7 in SARS-CoV-2 Viral Load
Baseline is defined as the last non-missing assessment recorded on or prior to the date of first study drug injection. Viral load is reported as normalized viral and is unitless.
Addendum (2): All randomized participants who received study drug and provided at least 1 postbaseline measure viral load measurement.
Posted
Mean
Standard Deviation
unitless
Baseline, Day 7
ID
Title
Description
OG000
700 mg BAM 15-min (Addendum (2))
Participants received 700 mg BAM administered IV.
Addendum 2 explored the safety of accelerated intravenous (IV) administration of BAM alone and in combination with ETE.
OG001
700 mg BAM + 1400 mg ETE 30-min (Addendum (2))
Participants received 700 mg BAM +1400 mg ETE administered IV.
Addendum 2 explored the safety of accelerated intravenous (IV) administration of BAM alone and in combination with ETE.
OG002
700 mg BAM + 1400 mg ETE 15-min (Addendum (2))
Participants received 700 mg BAM +1400 mg ETE administered IV.
Addendum 2 explored the safety of accelerated intravenous (IV) administration of BAM alone and in combination with ETE.
Secondary
Treatment 1-6 and Unintentional Dosing Arms: Percentage of Participants Demonstrating Symptom Resolution
Symptoms associated with COVID-19 were evaluated using a questionnaire that contains the following symptoms: cough, shortness of breath, feeling feverish, fatigue, body aches and pain, sore throat, chills, headache, loss of appetite, and loss in taste and smell. Each symptom (excluding loss of taste and smell) was scored daily by the participant as experienced during the past 24 hours with following rating and score: None or absent (0), Mild (1), Moderate (2) and Severe (3). Loss of taste and smell was scored as Yes (Y) or No (N). Symptom resolution (yes/no) is defined as all symptoms (excluding loss of appetite, taste, and smell) on the symptom questionnaire scored as absent (score of 0). Missing data was imputed using a non-responder imputation.
Treatment 1-6 and Unintentional Dosing Arms: All randomized participants who received study drug, provided at least 1 postbaseline measure viral load measurement and had non-missing Symptom Resolution values.
Posted
Number
95% Confidence Interval
percentage of participants
Day 7
ID
Title
Description
OG000
Treatment 1: Pbo
Participants received placebo (Pbo) administered intravenously (IV).
OG001
Treatment 2: 175 mg BAM +350 mg ETE
Participants received 175 milligrams (mg) bamlanivimab (BAM) +350 mg etesevimab (ETE) administered IV.
Secondary
Treatment 7-8 Amendments (C-e): Percentage of Participants Demonstrating Symptom Resolution
Symptoms associated with COVID-19 were evaluated using a questionnaire that contains the following symptoms: cough, shortness of breath, feeling feverish, fatigue, body aches and pain, sore throat, chills, headache, loss of appetite, and loss in taste and smell. Each symptom (excluding loss of taste and smell) was scored daily by the participant as experienced during the past 24 hours with following rating and score: None or absent (0), Mild (1), Moderate (2) and Severe (3). Loss of taste and smell was scored as Yes (Y) or No (N). Symptom resolution (yes/no) is defined as all symptoms (excluding loss of appetite, taste, and smell) on the symptom questionnaire scored as absent (score of 0). Missing data was imputed using a non-responder imputation.
Treatment 7-8 Amendments (c-e): All randomized participants who received study drug, provided at least 1 postbaseline measure viral load measurement and had non-missing Symptom Resolution values.
Symptoms associated with COVID-19 were evaluated using a questionnaire that contains the following symptoms: cough, shortness of breath, feeling feverish, fatigue, body aches and pain, sore throat, chills, headache, loss of appetite, and loss in taste and smell. Each symptom (excluding loss of taste and smell) was scored daily by the participant as experienced during the past 24 hours with following rating and score: None or absent (0), Mild (1), Moderate (2) and Severe (3). Loss of taste and smell was scored as Yes (Y) or No (N). Symptom resolution (yes/no) is defined as a score of 0 for shortness of breath, feeling feverish, body aches and pains, sore throat, chills, and headache, and a score of 0 or 1 for cough and fatigue on the symptom questionnaire. Missing data was imputed using a non-responder imputation.
Treatment 9-11 Amendment (f), Low Risk Participants: All randomized participants who received study drug, provided at least 1 postbaseline measure viral load measurement and had non-missing Symptom Resolution values.
Treatment 12 -13 Amendment (f), High Risk Participants: Percentage of Participants Demonstrating Symptom Resolution
Symptoms associated with COVID-19 were evaluated using a questionnaire that contains the following symptoms: cough, shortness of breath, feeling feverish, fatigue, body aches and pain, sore throat, chills, headache, loss of appetite, and loss in taste and smell. Each symptom (excluding loss of taste and smell) was scored daily by the participant as experienced during the past 24 hours with following rating and score: None or absent (0), Mild (1), Moderate (2) and Severe (3). Loss of taste and smell was scored as Yes (Y) or No (N). Symptom resolution (yes/no) is defined as a score of 0 for shortness of breath, feeling feverish, body aches and pains, sore throat, chills, and headache, and a score of 0 or 1 for cough and fatigue on the symptom questionnaire. Missing data was imputed using a non-responder imputation.
Treatment 12 -13 Amendment (f), High Risk Participants: All randomized participants who received study drug, provided at least 1 postbaseline measure viral load measurement and had non-missing Symptom Resolution values.
Posted
Number
95% Confidence Interval
percentage of participants
Day 7
ID
Title
Description
OG000
Treatment 12: 175 mg BEB (Amendment (f), High Risk Participants)
Treatment 14, Amendment (g) High Risk Participants Updated CDC Criteria Amendment (g): Percentage of Participants Demonstrating Symptom Resolution
Symptoms associated with COVID-19 were evaluated using a questionnaire that contains the following symptoms: cough, shortness of breath, feeling feverish, fatigue, body aches and pain, sore throat, chills, headache, loss of appetite, and loss in taste and smell. Each symptom (excluding loss of taste and smell) was scored daily by the participant as experienced during the past 24 hours with following rating and score: None or absent (0), Mild (1), Moderate (2) and Severe (3). Loss of taste and smell was scored as Yes (Y) or No (N). Symptom resolution (yes/no) is defined as a score of 0 for shortness of breath, feeling feverish, body aches and pains, sore throat, chills, and headache, and a score of 0 or 1 for cough and fatigue on the symptom questionnaire. Missing data was imputed using a non-responder imputation.
Treatment 14, Amendment (g) High Risk Participants Updated CDC Criteria Amendment (g): All randomized participants who received study drug, provided at least 1 postbaseline measure viral load measurement and had non-missing Symptom Resolution values.
Participants received 700 mg BAM +1400 mg ETE + 175 mg BEB administered IV.
Units
Secondary
Treatment 1-6 and Unintentional Dosing Arms: Percentage of Participants Demonstrating Symptom Improvement
Symptoms associated with COVID-19 were evaluated using a questionnaire that contains the following symptoms: cough, shortness of breath, feeling feverish, fatigue, body aches and pain, sore throat, chills, headache, loss of appetite, and loss in taste and smell. Each symptom (excluding loss of taste and smell) was scored daily by the participant as experienced during the past 24 hours with following rating and score: None or absent (0), Mild (1), Moderate (2) and Severe (3). Loss of taste and smell was scored as Yes (Y) or No (N). Symptom improvement (yes/no) is defined as a patient experiencing symptoms on the symptom questionnaire (excluding loss of appetite, taste, and smell) scored as moderate or severe (score of 2 or 3) at baseline are subsequently scored as mild or absent (score of 1 or 0), AND symptoms on the symptom questionnaire scored as mild or absent at baseline are subsequently scored as absent.
Treatment 1-6 and Unintentional Dosing Arms: All randomized participants who received study drug, provided at least 1 postbaseline measure viral load measurement and had non-missing Symptom Improvement values.
Posted
Number
95% Confidence Interval
percentage of participants
Day 7
ID
Title
Description
OG000
Placebo
Participants received placebo administered intravenously (IV).
OG001
175 mg Bamlanivimab +350 mg Etesevimab
Secondary
Treatment 7-8 Amendments (C-E): Percentage of Participants Demonstrating Symptom Improvement
Symptoms associated with COVID-19 were evaluated using a questionnaire that contains the following symptoms: cough, shortness of breath, feeling feverish, fatigue, body aches and pain, sore throat, chills, headache, loss of appetite, and loss in taste and smell. Each symptom (excluding loss of taste and smell) was scored daily by the participant as experienced during the past 24 hours with following rating and score: None or absent (0), Mild (1), Moderate (2) and Severe (3). Loss of taste and smell was scored as Yes (Y) or No (N). Symptom improvement (yes/no) is defined as a patient experiencing symptoms on the symptom questionnaire (excluding loss of appetite, taste, and smell) scored as moderate or severe (score of 2 or 3) at baseline are subsequently scored as mild or absent (score of 1 or 0), AND symptoms on the symptom questionnaire scored as mild or absent at baseline are subsequently scored as absent.
Treatment 7-8 Amendments (C-E): All randomized participants who received study drug, provided at least 1 postbaseline measure viral load measurement and had non-missing Symptom Improvement values.
Symptoms associated with COVID-19 were evaluated using a questionnaire that contains the following symptoms: cough, shortness of breath, feeling feverish, fatigue, body aches and pain, sore throat, chills, headache, loss of appetite, and loss in taste and smell. Each symptom (excluding loss of taste and smell) was scored daily by the participant as experienced during the past 24 hours with following rating and score: None or absent (0), Mild (1), Moderate (2) and Severe (3). Loss of taste and smell was scored as Yes (Y) or No (N). Symptom improvement (yes/no) is defined as a patient experiencing symptoms on the symptom questionnaire (excluding loss of appetite, taste, and smell) scored as moderate or severe (score of 2 or 3) at baseline are subsequently scored as mild or absent (score of 1 or 0), AND symptoms on the symptom questionnaire scored as mild or absent at baseline are subsequently scored as absent.
Treatment 9-11 Amendment (f), Low Risk Participants: All randomized participants who received study drug, provided at least 1 postbaseline measure viral load measurement and and had non-missing Symptom Improvement values.
Treatment 12 -13 Amendment (f), High Risk Participants: Percentage of Participants Demonstrating Symptom Improvement
Symptoms associated with COVID-19 were evaluated using a questionnaire that contains the following symptoms: cough, shortness of breath, feeling feverish, fatigue, body aches and pain, sore throat, chills, headache, loss of appetite, and loss in taste and smell. Each symptom (excluding loss of taste and smell) was scored daily by the participant as experienced during the past 24 hours with following rating and score: None or absent (0), Mild (1), Moderate (2) and Severe (3). Loss of taste and smell was scored as Yes (Y) or No (N). Symptom improvement (yes/no) is defined as a patient experiencing symptoms on the symptom questionnaire (excluding loss of appetite, taste, and smell) scored as moderate or severe (score of 2 or 3) at baseline are subsequently scored as mild or absent (score of 1 or 0), AND symptoms on the symptom questionnaire scored as mild or absent at baseline are subsequently scored as absent.
Treatment 12 -13 Amendment (f), High Risk Participants: All randomized participants who received study drug, provided at least 1 postbaseline measure viral load measurement and had non-missing Symptom Improvement values.
Posted
Number
95% Confidence Interval
percentage of participants
Day 7
ID
Title
Description
OG000
Treatment 12: 175 mg BEB (Amendment (f), High Risk Participants)
Treatment 14 Amendment (g): Percentage of Participants Demonstrating Symptom Improvement
Symptoms associated with COVID-19 were evaluated using a questionnaire that contains the following symptoms: cough, shortness of breath, feeling feverish, fatigue, body aches and pain, sore throat, chills, headache, loss of appetite, and loss in taste and smell. Each symptom (excluding loss of taste and smell) was scored daily by the participant as experienced during the past 24 hours with following rating and score: None or absent (0), Mild (1), Moderate (2) and Severe (3). Loss of taste and smell was scored as Yes (Y) or No (N). Symptom improvement (yes/no) is defined as a patient experiencing symptoms on the symptom questionnaire (excluding loss of appetite, taste, and smell) scored as moderate or severe (score of 2 or 3) at baseline are subsequently scored as mild or absent (score of 1 or 0), AND symptoms on the symptom questionnaire scored as mild or absent at baseline are subsequently scored as absent.
Treatment 14 Amendment (g): All randomized participants who received study drug, provided at least 1 postbaseline measure viral load measurement and had non-missing Symptom Improvement values.
Participants received 700 mg BAM +1400 mg ETE + 175 mg BEB administered IV for participants in updated CDC criteria..
Secondary
Treatment 1-6 and Unintentional Dosing Arms: Percentage of Participants Who Experience COVID-19 Related Hospitalization, COVID-19 Related Emergency Room Visit, or Death From Any Cause
Percentage of Participants Who Experience COVID-19 Related Hospitalization, COVID-19 Related Emergency Room Visit, or Death From Any Cause
Treatment 1-6 and Unintentional Dosing Arms: All participants randomly assigned and who received any amount of study drug.
Posted
Number
95% Confidence Interval
percentage of participants
Baseline through Day 29
ID
Title
Description
OG000
Treatment 1: Pbo
Participants received placebo (Pbo) administered intravenously (IV).
OG001
Treatment 2: 175 mg BAM +350 mg ETE
Participants received 175 milligrams (mg) bamlanivimab (BAM) +350 mg etesevimab (ETE) administered IV.
OG002
Treatment 3: 700 mg BAM +1400 mg ETE
Participants received 700 mg BAM +1400 mg ETE administered IV.
OG003
Treatment 4: 2800 mg BAM +2800 mg ETE
Secondary
Treatment 7-8 Amendments (C-E): Percentage of Participants Who Experience COVID-19 Related Hospitalization, COVID-19 Related Emergency Room Visit, or Death From Any Cause
Percentage of Participants Who Experience COVID-19 Related Hospitalization, COVID-19 Related Emergency Room Visit, or Death From Any Cause
Treatment 7-8 Amendment (C-E): No participants met the criteria (duration had to be 24 or more, and had to occur on Day 29 or before).
Treatment 9-11 Amendment (f), Low Risk Participants: Percentage of Participants Who Experience COVID-19 Related Hospitalization, COVID-19 Related Emergency Room Visit, or Death From Any Cause
Percentage of Participants Who Experience COVID-19 Related Hospitalization, COVID-19 Related Emergency Room Visit, or Death From Any Cause
Treatment 9-11 Amendment (f), Low Risk Participants: All participants randomly assigned and who received any amount of study drug.
Treatment 12 -13 Amendment (f), High Risk Participants: Percentage of Participants Who Experience COVID-19 Related Hospitalization, COVID-19 Related Emergency Room Visit, or Death From Any Cause
Percentage of Participants Who Experience COVID-19 Related Hospitalization, COVID-19 Related Emergency Room Visit, or Death From Any Cause
Treatment 12 -13 Amendment (f), High Risk Participants: All participants randomly assigned and who received any amount of study drug.
Posted
Number
95% Confidence Interval
percentage of participants
Baseline through Day 29
ID
Title
Description
OG000
Treatment 12: 175 mg BEB (Amendment (f), High Risk Participants)
Participants received 700 mg BAM +1400 mg ETE + 175 mg BEB administered IV.
Units
Counts
Participants
Secondary
Treatment 14 Amendment (g): Percentage of Participants Who Experience COVID-19 Related Hospitalization, COVID-19 Related Emergency Room Visit, or Death From Any Cause
Percentage of Participants Who Experience COVID-19 Related Hospitalization, COVID-19 Related Emergency Room Visit, or Death From Any Cause
Treatment 14 Amendment (g): All participants randomly assigned and who received any amount of study drug.
Participants received 700 mg BAM +1400 mg ETE + 175 mg BEB administered IV for participants in updated CDC criteria.
Units
Counts
Participants
OG000
Secondary
Pharmacokinetics (PK): Mean Concentration of Bamlanivimab
PK: Mean Concentration of Bamlanivimab
All randomized participants who received 700 mg BAM and had evaluable PK data.
Posted
Geometric Least Squares Mean
Geometric Coefficient of Variation
Microgram/milliliter (µg/mL)
Day 29
ID
Title
Description
OG000
700 mg BAM
Participants received 700 mg BAM administered IV.
Units
Counts
Participants
OG000374
Secondary
Pharmacokinetics (PK): Mean Concentration of Etesevimab
Pharmacokinetics (PK): Mean Concentration of Etesevimab
All randomized participants who received 1400 ETE and had evaluable PK data.
Posted
Geometric Least Squares Mean
Geometric Coefficient of Variation
µg/mL
Day 29
ID
Title
Description
OG000
1400 mg ETE
Participants received 1400 mg ETE administered IV.
Units
Counts
Participants
OG000319
Secondary
Pharmacokinetics (PK): Mean Concentration of Bebtelovimab
Pharmacokinetics (PK): Mean Concentration of Bebtelovimab
All randomized participants who received 175 mg BEB and had evaluable PK data.
Posted
Geometric Least Squares Mean
Geometric Coefficient of Variation
µg/mL
Day 29
ID
Title
Description
OG000
175 mg BEB
Participants received 175 mg BEB administered IV.
Units
Counts
Participants
OG000520
Secondary
Pharmacokinetics (PK): Mean Concentration of VIR-7831
PK: Mean Concentration of VIR-7831
All randomized participants who received 500 mg VIR-7831 and had evaluable PK data.
Posted
Geometric Least Squares Mean
Geometric Coefficient of Variation
µg/mL
Day 29
ID
Title
Description
OG000
500 mg VIR-7831
Participants received 500 mg VIR-7831 administered IV.
Units
Counts
Participants
OG00064
Time Frame
Baseline Up To 169 Days
Description
All 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.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Treatment 1: Pbo
Participants received placebo (Pbo) administered intravenously (IV).
0
155
0
155
16
155
EG001
Treatment 2: 175 mg BAM +350 mg ETE
Participants received 175 milligrams (mg) bamlanivimab (BAM) +350 mg etesevimab (ETE) administered IV.
0
83
0
83
14
83
EG002
Treatment 3: 700 mg BAM +1400 mg ETE
Participants received 700 mg BAM +1400 mg ETE administered IV.
0
158
1
158
13
158
EG003
Treatment 4: 2800 mg BAM +2800 mg ETE
Participants received 2800 mg BAM + 2800 mg ETE administered IV.
0
103
0
103
9
103
EG004
Treatment 5: 700 mg BAM
Participants received 700 mg BAM administered IV.
0
105
0
105
12
105
EG005
Treatment 6: 350 mg BAM +700 mg ETE
Participants received 350 mg BAM +700 mg ETE administered IV.
0
101
2
101
7
101
EG006
Unintentional Dosing: 700 mg BAM +700 mg ETE
Participants received 700 mg BAM +700 mg ETE administered IV.