A Study of Immune System Proteins in Participants With Mild to Moderate COVID-19 Illness
BLAZE-4
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)
2 other identifiers
interventional
1,755
3 countries
141
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 covid19
Started Oct 2020
Typical duration for phase_2 covid19
141 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 29, 2020
CompletedFirst Submitted
Initial submission to the registry
November 17, 2020
CompletedFirst Posted
Study publicly available on registry
November 18, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 27, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
October 18, 2021
CompletedResults Posted
Study results publicly available
July 1, 2022
CompletedJuly 1, 2022
June 1, 2022
9 months
November 17, 2020
June 7, 2022
June 7, 2022
Conditions
Outcome Measures
Primary Outcomes (3)
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 (37)
Treatment 12 -13, Amendment (f) High Risk Participants: Percentage of Participants With SARS-CoV-2 Viral Load Greater Than 5.27
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
Day 7
Addendum (2): Percentage of Participants With SARS-CoV-2 Viral Load Greater Than 5.27
Day 7
Addendum (4), Arm A - Intravenous: Percentage of Participants With SARS-CoV-2 Viral Load Greater Than 5.27
Day 7
Addendum (4) Arm B - Subcutaneous: Percentage of Participants With SARS-CoV-2 Viral Load Greater Than 5.27
Day 7
- +32 more secondary outcomes
Study Arms (6)
Placebo (Pbo)
PLACEBO COMPARATORTreatment 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.
BAM + ETE
EXPERIMENTALTreatment 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.
BAM
EXPERIMENTALTreatment 5: 700 mg BAM administered IV. 700 mg BAM 15-min (Addendum (2)) administered IV.
BAM + VIR-7831
EXPERIMENTALTreatment 7: 700 mg BAM + 500 mg VIR-7831 (Amendment (C-e)) administered IV.
BEB
EXPERIMENTALTreatment 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.
BAM+ ETE + BEB
EXPERIMENTALTreatment 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.
Interventions
Administered IV.
Eligibility Criteria
You may qualify if:
- 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
- +29 more criteria
You may not qualify if:
- 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
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Eli Lilly and Companylead
- AbCellera Biologics Inc.collaborator
- Shanghai Junshi Bioscience Co., Ltd.collaborator
- GlaxoSmithKlinecollaborator
- Vir Biotechnology, Inc.collaborator
Study Sites (141)
University of Alabama at Birmingham
Birmingham, Alabama, 35233, United States
The Institute for Liver Health
Mesa, Arizona, 85210, United States
Perseverance Research Center
Scottsdale, Arizona, 85254, United States
CRI of Arizona, LLC
Sun City West, Arizona, 85375, United States
Fiel Family and Sports Medicine PC
Tempe, Arizona, 85283, United States
The Institute for Liver Health
Tucson, Arizona, 85712, United States
KLR Business Group, Inc. dba Arkansas Clinical Research
Little Rock, Arkansas, 72205, United States
Applied Rsch Ctr - Arkansas Inc.
Little Rock, Arkansas, 72212, United States
Smart Cures Clin Research
Anaheim, California, 92806, United States
Hope Clinical Research
Canoga Park, California, 91303, United States
VCT-Covina
Covina, California, 91723, United States
Neighborhood Healthcare
Escondido, California, 92025, United States
Chemidox Clinical Trials
Lancaster, California, 93534, United States
Ark Clinical Research
Long Beach, California, 90806, United States
Long Beach Clinical Trials LLC
Long Beach, California, 90806, United States
Cedars Sinai Medical Center
Los Angeles, California, 90048-5615, United States
Central Valley Research, LLC
Modesto, California, 95350, United States
Inland Empire Liver Foundation
Rialto, California, 92377, United States
Sutter Institute For Medical Research
Sacramento, California, 95816, United States
Wolverine Clinical Trials, LLC
Santa Ana, California, 92705, United States
St. Joe Heritage HC-Santa Rosa
Santa Rosa, California, 95405, United States
Stanford University Hospital
Stanford, California, 94305, United States
Mazur, Statner, Dutta, Nathan
Thousand Oaks, California, 91360, United States
South Bay Clinical Research Institute
Torrance, California, 90503, United States
Infect Disease Doctors Med Grp
Walnut Creek, California, 94598, United States
Allianz Research Institute
Westminster, California, 92683, United States
Future Innovative Treatments LLC
Colorado Springs, Colorado, 80907, United States
Georgetown Univ Sch of Med
Washington D.C., District of Columbia, 20007, United States
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, 33012, United States
Encore Medical Research
Hollywood, Florida, 33021, United States
Elixia CRC
Hollywood, Florida, 33023, United States
Lakeland Regional Medical Center
Lakeland, Florida, 33804, United States
Hope Clinical Trials, Inc.
Miami, Florida, 33165, United States
Miami Cancer Institute at Baptist Health, Inc.
Miami, Florida, 33176, United States
Bio-Medical Research, LLC
Miami, Florida, 33184, United States
Clinical Site Partners, LLC d/b/a CSP Miami
Miami, Florida, 33186, United States
Panax Clinical Research
Miami Lakes, Florida, 33014, United States
Testing Matters Lab
Sunrise, Florida, 33325, United States
Advent Health Tampa
Tampa, Florida, 33613, United States
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, United States
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, United States
Rophe Adult and Pediatric Medicine
Union City, Georgia, 30291, United States
Rocky Mountain Clinical Research
Idaho Falls, Idaho, 83404, United States
Ann & Robert H Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611, United States
Great Lakes Clinical Trials
Chicago, Illinois, 60640, United States
Franciscan Health Hammond
Dyer, Indiana, 46311, United States
Qualmedica Research Evansville
Evansville, Indiana, 47715, United States
Franciscan St. Francis Health
Indianapolis, Indiana, 46237, United States
St.Vincent - Indy
Indianapolis, Indiana, 46260, United States
Qualmedica Research, LLC
Owensboro, Kentucky, 42301, United States
Tandem Clinical Research,LLC
Marrero, Louisiana, 70072, United States
Imperial Health Urgent Care Center - Moss Bluff
Moss Bluff, Louisiana, 70611, United States
Nola Research Works, LLC
New Orleans, Louisiana, 70125, United States
University of Maryland Medical Center
Baltimore, Maryland, 21201, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
U of MA Mem Med Ctr
Worcester, Massachusetts, 01605, United States
University of Michigan
Ann Arbor, Michigan, 48109, United States
Great Lakes Research Group, Inc.
Bay City, Michigan, 48706, United States
Revive Research Institute
Farmington Hills, Michigan, 48334, United States
Revival Research Institute
Sterling Heights, Michigan, 48312, United States
Sky Clinical Prime and Health Wellness Clinic
Fayette, Mississippi, 39069, United States
Olive Branch Family Medical Center
Olive Branch, Mississippi, 38654, United States
Sky Clin Resch - Quinn HC
Ridgeland, Mississippi, 39157, United States
Bio-Kinetic Clinical Applications, LLC
Springfield, Missouri, 65802, United States
Quality Clinical Research
Omaha, Nebraska, 68114, United States
Excel Clinical Research
Las Vegas, Nevada, 89109, United States
Las Vegas Medical Research
Las Vegas, Nevada, 89113, United States
SVG Clinical
Las Vegas, Nevada, 89128, United States
Holy Name Medical Center
Teaneck, New Jersey, 07666, United States
Prime Global Research, LLC
The Bronx, New York, 10456, United States
Onsite Clinical Solutions, LLC
Charlotte, North Carolina, 28226, United States
East Carolina University
Greenville, North Carolina, 27834, United States
Monroe Biomed Research
Monroe, North Carolina, 28112, United States
Carteret Medical Group
Morehead City, North Carolina, 28557, United States
PMG Research of Wilmington
Wilmington, North Carolina, 28401, United States
Valley Medical Primary Care
Centerville, Ohio, 45459, United States
Hometown UC and Rch- Cincy
Cincinnati, Ohio, 45215, United States
Aventiv Research Inc
Columbus, Ohio, 43213, United States
Urgent Care Specialists, LLC
Columbus, Ohio, 43214, United States
Remington-Davis, Inc
Columbus, Ohio, 43215, United States
Urgent Care Specialists, LLC
Dayton, Ohio, 45424, United States
META Medical Research Institute
Dayton, Ohio, 45432, United States
Ascension St. John Tulsa OK
Tulsa, Oklahoma, 74104, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 18901, United States
Jefferson Hosp for Neurosci
Philadelphia, Pennsylvania, 19107, United States
Temple University Hospital
Philadelphia, Pennsylvania, 19140, United States
VITALINK - Anderson
Anderson, South Carolina, 29621, United States
Carolina Medical Research - Clinton
Clinton, South Carolina, 29325, United States
VITALINK - Gaffney
Gaffney, South Carolina, 29340, United States
Carolina Medical Research - Greenville
Greenville, South Carolina, 29607, United States
VITALINK - Greenville
Greenville, South Carolina, 29615, United States
VITALINK - Spartanburg
Spartanburg, South Carolina, 29303, United States
VITALINK - Union
Union, South Carolina, 29379, United States
Univ Diab & Endo Consult
Chattanooga, Tennessee, 37411, United States
New Phase Research and Development
Knoxville, Tennessee, 37909, United States
Gadolin Research, LLC
Beaumont, Texas, 77702, United States
Conroe Willis Medical Research
Conroe, Texas, 77304, United States
Crossroads Clinical Research
Corpus Christi, Texas, 78413, United States
B S & W Med Center
Dallas, Texas, 75246, United States
Baylor - Fort Worth
Fort Worth, Texas, 76104, United States
North Texas Clinical Trials, LLC
Fort Worth, Texas, 76104, United States
Houston Methodist Research Ins
Houston, Texas, 77030, United States
Next Level Urgent Care
Houston, Texas, 77057, United States
Accurate Clinical Management, LLC.
Houston, Texas, 77065, United States
1960 Family Practice, PA
Houston, Texas, 77090, United States
B S & W Med Center
Irving, Texas, 75061, United States
Zion Urgent Care Clinic
Katy, Texas, 77494, United States
BioPharma Family Practice Center McAllen
McAllen, Texas, 78501, United States
BRCR Medical Center, Inc
McAllen, Texas, 78501, United States
North Hills Medical Research
North Richland Hills, Texas, 76180, United States
Bay Area Infectious Diseases Associates
Pasadena, Texas, 77505, United States
Epic Medical Research
Red Oak, Texas, 75154, United States
Baylor - Round Rock
Round Rock, Texas, 78665, United States
Sun Research Institute
San Antonio, Texas, 78215, United States
Consano Clinical Research, LLC
Shavano Park, Texas, 78231, United States
APD Clinical Research
Splendora, Texas, 77372, United States
Crossroads Clin Rch-Victoria
Victoria, Texas, 77901, United States
CLS Research Ctr, PLLC
Webster, Texas, 77598, United States
CARE ID
Annandale, Virginia, 22003, United States
Evergreen Health Research
Kirkland, Washington, 98034, United States
Sanatorio Sagrado Corazón
Ciudad de Buenos Aires, AR, C1039AAC, Argentina
Clínica Zabala
Ciudad de Buenos Aires, AR, C1426AAM, Argentina
Sanatorio de la Trinidad Mitre
CABA, Buenos Aires, C1039AAO, Argentina
Clínica Privada Independencia
Munro, Buenos Aires, Argentina
Go Centro Medico San Nicolás
San Nicolás de los Arroyos, Buenos Aires, B2900DPA, Argentina
Instituto de Investigaciones Clinicas Zarate
Zárate, Buenos Aires, 2800, Argentina
Instituto Médico Rio Cuarto
Río Cuarto, Córdoba Province, X5800AEV, Argentina
Centro de Investigaciones Clínicas - Clínica Viedma
Viedma, Río Negro Province, 8500, Argentina
Clinica Central S.A.
Villa Regina, Río Negro Province, R8336, Argentina
INECO Neurociencias Oroño
Rosario, Santa Fe Province, S2000, Argentina
Hospital San Roque
Córdoba, 5000, Argentina
Advanced Clinical Research, LLC
Bayamón, 00961, Puerto Rico
Dorado Medical Complex Inc
Dorado, 00646, Puerto Rico
GCM Medical Group, PSC - Hato Rey Site
San Juan, 00917, Puerto Rico
Related Publications (4)
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.
PMID: 38291279DERIVEDHirsch C, Park YS, Piechotta V, Chai KL, Estcourt LJ, Monsef I, Salomon S, Wood EM, So-Osman C, McQuilten Z, Spinner CD, Malin JJ, Stegemann M, Skoetz N, Kreuzberger N. SARS-CoV-2-neutralising monoclonal antibodies to prevent COVID-19. Cochrane Database Syst Rev. 2022 Jun 17;6(6):CD014945. doi: 10.1002/14651858.CD014945.pub2.
PMID: 35713300DERIVEDKreuzberger N, Hirsch C, Chai KL, Tomlinson E, Khosravi Z, Popp M, Neidhardt M, Piechotta V, Salomon S, Valk SJ, Monsef I, Schmaderer C, Wood EM, So-Osman C, Roberts DJ, McQuilten Z, Estcourt LJ, Skoetz N. SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19. Cochrane Database Syst Rev. 2021 Sep 2;9(9):CD013825. doi: 10.1002/14651858.CD013825.pub2.
PMID: 34473343DERIVEDNathan 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.
PMID: 34374951DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Chief Medical Officer
- Organization
- Eli Lilly and Company
Study Officials
- STUDY DIRECTOR
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Eli Lilly and Company
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Masking Details
- Includes open label arms
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 17, 2020
First Posted
November 18, 2020
Study Start
October 29, 2020
Primary Completion
July 27, 2021
Study Completion
October 18, 2021
Last Updated
July 1, 2022
Results First Posted
July 1, 2022
Record last verified: 2022-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- 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.