Little Rock, Arkansas 72205

  • 19

Purpose:

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.


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 a BMI ≥85th percentile for their age and gender based on CDC growth charts, https://www.cdc.gov/growthcharts/clinical_charts.htm - Have sickle cell disease - Have congenital or acquired heart disease - 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


Study is Available At:


Original ID:

18160


NCT ID:

NCT04634409


Secondary ID:

J2X-MC-PYAH


Study Acronym:

BLAZE-4


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)


Overall Status:

Completed


Study Phase:

Phase 2


Genders:

N/A


Minimum Age:

12 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Eli Lilly and Company


Oversight Authority:

There was an error processing this request


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

6


Number of Groups:

0


Total Enrollment:

1755


Enrollment Type:

Actual


Overall Contact Information

Official Name: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)
Study Director
Eli Lilly and Company

Study Dates

Start Date:October 29, 2020
Completion Date:October 18, 2021
Completion Type:Actual
Primary Completion Date:July 27, 2021
Primary Completion Type:Actual
Verification Date:June 2022
Last Changed Date:June 7, 2022
First Received Date:November 17, 2020
First Results Date:June 7, 2022

Study Outcomes

Outcome Type:Primary Outcome
Measure: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
Time Frame:Day 7
Safety Issues:False
Description: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 d
Outcome Type:Primary Outcome
Measure:Treatment 7-8, Amendments (C-e): Percentage of Participants With SARS-CoV-2 Viral Load Greater Than 5.27
Time Frame:Day 7
Safety Issues:False
Description: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).
Outcome Type:Primary Outcome
Measure:Treatment 9-11 Amendment (f), Low Risk Participants: Percentage of Participants With SARS-CoV-2 Viral Load Greater Than 5.27
Time Frame:Day 7
Safety Issues:False
Description: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).
Outcome Type:Secondary Outcome
Measure:Treatment 12 -13, Amendment (f) High Risk Participants: Percentage of Participants With SARS-CoV-2 Viral Load Greater Than 5.27
Time Frame:Day 7
Safety Issues:False
Description: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).
Outcome Type:Secondary Outcome
Measure:Treatment 14, Amendment (f) High Risk Participants Updated CDC Criteria: Percentage of Participants With SARS-CoV-2 Viral Load Greater Than 5.27
Time Frame:Day 7
Safety Issues:False
Description: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).
Outcome Type:Secondary Outcome
Measure:Addendum (2): Percentage of Participants With SARS-CoV-2 Viral Load Greater Than 5.27
Time Frame:Day 7
Safety Issues:False
Description: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.
Outcome Type:Secondary Outcome
Measure:Addendum (4), Arm A - Intravenous: Percentage of Participants With SARS-CoV-2 Viral Load Greater Than 5.27
Time Frame:Day 7
Safety Issues:False
Description: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).
Outcome Type:Secondary Outcome
Measure:Addendum (4) Arm B - Subcutaneous: Percentage of Participants With SARS-CoV-2 Viral Load Greater Than 5.27
Time Frame:Day 7
Safety Issues:False
Description: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).
Outcome Type:Secondary Outcome
Measure:Treatment 1-6 and Unintentional Dosing Arms: Percentage of Participants Who Experience COVID-19 Related Hospitalization or Death From Any Cause
Time Frame:Baseline through Day 29
Safety Issues:False
Description:Percentage of Participants Who Experience COVID-19 Related Hospitalization or Death from any Cause
Outcome Type:Secondary Outcome
Measure:Treatment 7-8, Amendment (C-E): Percentage of Participants Who Experience COVID-19 Related Hospitalization or Death From Any Cause
Time Frame:Baseline through Day 29
Safety Issues:False
Description:Percentage of Participants Who Experience COVID-19 Related Hospitalization or Death from Any Cause
Outcome Type:Secondary Outcome
Measure:Treatment 9-11 Amendment (f), Low Risk Participants: Percentage of Participants Who Experience COVID-19 Related Hospitalization or Death From Any Cause
Time Frame:Baseline through Day 29
Safety Issues:False
Description:Percentage of Participants Who Experience COVID-19 Related Hospitalization or Death From Any Cause
Outcome Type:Secondary Outcome
Measure:Treatment 12 -13 Amendment (f), High Risk Participants: Percentage of Participants Who Experience COVID-19 Related Hospitalization or Death From Any Cause
Time Frame:Baseline through Day 29
Safety Issues:False
Description:Percentage of Participants Who Experience COVID-19 Related Hospitalization or Death From Any Cause
Outcome Type:Secondary Outcome
Measure:Treatment 14 Amendment (f) High Risk Participants, Updated CDC Criteria: Percentage of Participants Who Experience COVID-19 Related Hospitalization or Death From Any Cause
Time Frame:Baseline through Day 29
Safety Issues:False
Description:Percentage of Participants Who Experience COVID-19 Related Hospitalization or Death From Any Cause
Outcome Type:Secondary Outcome
Measure:Treatment 1-6 and Unintentional Dosing Arms: Change From Baseline to Day 7 in SARS-CoV-2 Viral Load
Time Frame:Baseline, Day 7
Safety Issues:False
Description: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
Outcome Type:Secondary Outcome
Measure:Treatment 7-8 Amendments (C-e): Change From Baseline to Day 7 in SARS-CoV-2 Viral Load
Time Frame:Baseline, Day 7
Safety Issues:False
Description: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.
Outcome Type:Secondary Outcome
Measure:Treatment 9-11 Amendment (f), Low Risk Participants: Change From Baseline to Day 7 in SARS-CoV-2 Viral Load
Time Frame:Baseline, Day 7
Safety Issues:False
Description: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.
Outcome Type:Secondary Outcome
Measure:Treatment 12 -13 Amendment (f), High Risk Participants: Change From Baseline to Day 7 in SARS-CoV-2 Viral Load
Time Frame:Baseline, Day 7
Safety Issues:False
Description: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.
Outcome Type:Secondary Outcome
Measure:Treatment 14, Amendment (f) High Risk Participants Updated CDC Criteria: Change From Baseline to Day 7 in SARS-CoV-2 Viral Load
Time Frame:Baseline, Day 7
Safety Issues:False
Description: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.
Outcome Type:Secondary Outcome
Measure:Addendum 4, IV: Change From Baseline to Day 7 in SARS-CoV-2 Viral Load
Time Frame:Baseline, Day 7
Safety Issues:False
Description: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.
Outcome Type:Secondary Outcome
Measure:Addendum 4, SC: Change From Baseline to Day 7 in SARS-CoV-2 Viral Load
Time Frame:Baseline, Day 7
Safety Issues:False
Description: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.
Outcome Type:Secondary Outcome
Measure:Addendum (2): Change From Baseline to Day 7 in SARS-CoV-2 Viral Load
Time Frame:Baseline, Day 7
Safety Issues:False
Description: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.
Outcome Type:Secondary Outcome
Measure:Treatment 1-6 and Unintentional Dosing Arms: Percentage of Participants Demonstrating Symptom Resolution
Time Frame:Day 7
Safety Issues:False
Description: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
Outcome Type:Secondary Outcome
Measure:Treatment 7-8 Amendments (C-e): Percentage of Participants Demonstrating Symptom Resolution
Time Frame:Day 7
Safety Issues:False
Description: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
Outcome Type:Secondary Outcome
Measure:Treatment 9-11 Amendment (f), Low Risk Participants: Percentage of Participants Demonstrating Symptom Resolution
Time Frame:Day 7
Safety Issues:False
Description: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
Outcome Type:Secondary Outcome
Measure:Treatment 12 -13 Amendment (f), High Risk Participants: Percentage of Participants Demonstrating Symptom Resolution
Time Frame:Day 7
Safety Issues:False
Description: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
Outcome Type:Secondary Outcome
Measure:Treatment 14, Amendment (g) High Risk Participants Updated CDC Criteria Amendment (g): Percentage of Participants Demonstrating Symptom Resolution
Time Frame:Day 7
Safety Issues:False
Description: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
Outcome Type:Secondary Outcome
Measure:Treatment 1-6 and Unintentional Dosing Arms: Percentage of Participants Demonstrating Symptom Improvement
Time Frame:Day 7
Safety Issues:False
Description: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
Outcome Type:Secondary Outcome
Measure:Treatment 7-8 Amendments (C-E): Percentage of Participants Demonstrating Symptom Improvement
Time Frame:Day 7
Safety Issues:False
Description: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
Outcome Type:Secondary Outcome
Measure:Treatment 9-11 Amendment (f), Low Risk Participants: Percentage of Participants Demonstrating Symptom Improvement
Time Frame:Day 7
Safety Issues:False
Description: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
Outcome Type:Secondary Outcome
Measure:Treatment 12 -13 Amendment (f), High Risk Participants: Percentage of Participants Demonstrating Symptom Improvement
Time Frame:Day 7
Safety Issues:False
Description: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
Outcome Type:Secondary Outcome
Measure:Treatment 14 Amendment (g): Percentage of Participants Demonstrating Symptom Improvement
Time Frame:Day 7
Safety Issues:False
Description: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
Outcome Type:Secondary Outcome
Measure: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
Time Frame:Baseline through Day 29
Safety Issues:False
Description:Percentage of Participants Who Experience COVID-19 Related Hospitalization, COVID-19 Related Emergency Room Visit, or Death From Any Cause
Outcome Type:Secondary Outcome
Measure: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
Time Frame:Baseline through Day 29
Safety Issues:False
Description:Percentage of Participants Who Experience COVID-19 Related Hospitalization, COVID-19 Related Emergency Room Visit, or Death From Any Cause
Outcome Type:Secondary Outcome
Measure: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
Time Frame:Baseline through Day 29
Safety Issues:False
Description:Percentage of Participants Who Experience COVID-19 Related Hospitalization, COVID-19 Related Emergency Room Visit, or Death From Any Cause
Outcome Type:Secondary Outcome
Measure: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
Time Frame:Baseline through Day 29
Safety Issues:False
Description:Percentage of Participants Who Experience COVID-19 Related Hospitalization, COVID-19 Related Emergency Room Visit, or Death From Any Cause
Outcome Type:Secondary Outcome
Measure:Treatment 14 Amendment (g): Percentage of Participants Who Experience COVID-19 Related Hospitalization, COVID-19 Related Emergency Room Visit, or Death From Any Cause
Time Frame:Baseline through Day 29
Safety Issues:False
Description:Percentage of Participants Who Experience COVID-19 Related Hospitalization, COVID-19 Related Emergency Room Visit, or Death From Any Cause
Outcome Type:Secondary Outcome
Measure:Pharmacokinetics (PK): Mean Concentration of Bamlanivimab
Time Frame:Day 29
Safety Issues:False
Description:PK: Mean Concentration of Bamlanivimab
Outcome Type:Secondary Outcome
Measure:Pharmacokinetics (PK): Mean Concentration of Etesevimab
Time Frame:Day 29
Safety Issues:False
Description:Pharmacokinetics (PK): Mean Concentration of Etesevimab
Outcome Type:Secondary Outcome
Measure:Pharmacokinetics (PK): Mean Concentration of Bebtelovimab
Time Frame:Day 29
Safety Issues:False
Description:Pharmacokinetics (PK): Mean Concentration of Bebtelovimab
Outcome Type:Secondary Outcome
Measure:Pharmacokinetics (PK): Mean Concentration of VIR-7831
Time Frame:Day 29
Safety Issues:False
Description:PK: Mean Concentration of VIR-7831

Study Interventions

Intervention Type:Drug
Name:Bamlanivimab
Description:Administered IV.
Arm Name:BAM
Other Name:LY-CoV555
Intervention Type:Drug
Name:Etesevimab
Description:Administered IV.
Arm Name:BAM + ETE
Other Name:LY-CoV016
Intervention Type:Drug
Name:Placebo
Description:Administered IV.
Arm Name:Placebo (Pbo)
Intervention Type:Drug
Name:VIR-7831
Description:Administered IV.
Arm Name:BAM + VIR-7831
Other Name:GSK4182136
Intervention Type:Drug
Name:Bebtelovimab
Description:Administered IV.
Arm Name:BAM+ ETE + BEB
Other Name:LY-CoV1404, LY3853113

Study Arms

Study Arm Type:Placebo Comparator
Arm Name:Placebo (Pbo)
Description:Treatment 1: Pbo administered intravenously (IV). Treatment 8: Pbo For 700 mg Bamlanivimab (BAM) + 500 mg VIR-7831 (Amendment (C-e)) administered IV. Treatment 11: Pbo For 175 mg Bebtelovimab (BEB) & 700 mg BAM +1400 mg Etesevimab ( ETE) +175 mg BEB (Low Risk Participants) administered IV. Pooled Placebo (Addendum 4, IV) administered IV. Pooled Placebo (Addendum 4, SC) administered SC.
Study Arm Type:Experimental
Arm Name:BAM + ETE
Description:Treatment 2: 175 mg BAM +350 mg ETE administered IV. Treatment 3: 700 mg BAM +1400 mg ETE administered IV. Treatment 4: 2800 mg BAM +2800 mg ETE administered IV. Treatment 6: 350 mg BAM +700 mg ETE administered IV. Unintentional Dosing: 700 mg BAM +700 mg ETE administered IV. 700 mg BAM + 1400 mg ETE 30-min (Addendum (2)) administered IV. 700 mg BAM + 1400 mg ETE 15-min (Addendum (2)) administered IV.
Study Arm Type:Experimental
Arm Name:BAM
Description:Treatment 5: 700 mg BAM administered IV. 700 mg BAM 15-min (Addendum (2)) administered IV.
Study Arm Type:Experimental
Arm Name:BAM + VIR-7831
Description:Treatment 7: 700 mg BAM + 500 mg VIR-7831 (Amendment (C-e)) administered IV.
Study Arm Type:Experimental
Arm Name:BEB
Description:Treatment 9: 175 mg BEB (Amendment (f), Low Risk Participants) administered IV. Treatment 12: 175 mg BEB (Amendment (f), High Risk Participants) administered IV. 70 mg BEB 140 mg/Min (Addendum 4, IV) administered IV. 175 mg BEB 140 mg/Min (Addendum 4, IV) administered IV. 175 mg BEB 350 mg/Min (Addendum 4, IV) administered IV. 1750 mg BEB 350 mg/Min (Addendum 4, IV) administered IV. 280 mg BEB (Addendum 4, SC) administered SC. 560 mg BEB (Addendum 4, SC) administered SC.
Study Arm Type:Experimental
Arm Name:BAM+ ETE + BEB
Description:Treatment 10: 700 mg BAM +1400 mg ETE +175 mg BEB (Amendment (f), Low Risk Participants) administered IV. Treatment 13: 700 mg BAM +1400 mg ETE +175 mg BEB (Amendment (f), High Risk Participants) administered IV. Treatment 14: 700 mg BAM + 1400 mg ETE + 175 mg BEB(Amendment (g), High Risk, Updated Centers for Disease Control and Prevention (CDC) Criteria) administered IV. 175/700/1400 mg BAM + ETE + BEB 350 mg/Min (Addendum 4, IV) administered IV.

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Eli Lilly and Company
Agency Class:Industry
Agency Type:Collaborator
Agency Name:AbCellera Biologics Inc.

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: February 03, 2023

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