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)

Who is this study for? Adult patients with COVID-19 Infection
Status: Completed
Location: See all (141) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 12
Healthy Volunteers: f
View:

• 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

Locations
United States
Alabama
University of Alabama at Birmingham
Birmingham
Arkansas
Applied Rsch Ctr - Arkansas Inc.
Little Rock
KLR Business Group, Inc. dba Arkansas Clinical Research
Little Rock
Arizona
The Institute for Liver Health
Mesa
Perseverance Research Center
Scottsdale
CRI of Arizona, LLC
Sun City West
Fiel Family and Sports Medicine PC
Tempe
The Institute for Liver Health
Tucson
California
Smart Cures Clin Research
Anaheim
Hope Clinical Research
Canoga Park
VCT-Covina
Covina
Neighborhood Healthcare
Escondido
Chemidox Clinical Trials
Lancaster
Ark Clinical Research
Long Beach
Long Beach Clinical Trials LLC
Long Beach
Cedars Sinai Medical Center
Los Angeles
Central Valley Research, LLC
Modesto
Inland Empire Liver Foundation
Rialto
Sutter Institute For Medical Research
Sacramento
Wolverine Clinical Trials, LLC
Santa Ana
St. Joe Heritage HC-Santa Rosa
Santa Rosa
Stanford University Hospital
Stanford
Mazur, Statner, Dutta, Nathan
Thousand Oaks
South Bay Clinical Research Institute
Torrance
Infect Disease Doctors Med Grp
Walnut Creek
Allianz Research Institute
Westminster
Colorado
Future Innovative Treatments LLC
Colorado Springs
Washington, D.c.
Georgetown Univ Sch of Med
Washington
Florida
Synergy Healthcare LLC
Bradenton
Holy Cross Hospital Inc.
Fort Lauderdale
I R & Health Center, Inc.
Hialeah
Elixia CRC
Hollywood
Encore Medical Research
Hollywood
Lakeland Regional Medical Center
Lakeland
Bio-Medical Research, LLC
Miami
Clinical Site Partners, LLC d/b/a CSP Miami
Miami
Hope Clinical Trials, Inc.
Miami
Miami Cancer Institute at Baptist Health, Inc.
Miami
Panax Clinical Research
Miami Lakes
Testing Matters Lab
Sunrise
Advent Health Tampa
Tampa
Triple O Research Inst
West Palm Beach
Encore Medical Research - Weston
Weston
Clinical Site Partners, LLC DBA CSP Orlando
Winter Park
Georgia
Gwinnett Research Inst
Buford
Paramount Rch Sol - College Pk
College Park
IACT Health - VHC
Columbus
Central Georgia Infectious Disease
Macon
Rophe Adult and Pediatric Medicine
Union City
Idaho
Rocky Mountain Clinical Research
Idaho Falls
Illinois
Ann & Robert H Lurie Children's Hospital of Chicago
Chicago
Great Lakes Clinical Trials
Chicago
Indiana
Franciscan Health Hammond
Dyer
Qualmedica Research Evansville
Evansville
Franciscan St. Francis Health
Indianapolis
St.Vincent - Indy
Indianapolis
Kentucky
Qualmedica Research, LLC
Owensboro
Louisiana
Tandem Clinical Research,LLC
Marrero
Imperial Health Urgent Care Center - Moss Bluff
Moss Bluff
Nola Research Works, LLC
New Orleans
Massachusetts
Massachusetts General Hospital
Boston
U of MA Mem Med Ctr
Worcester
Maryland
University of Maryland Medical Center
Baltimore
Michigan
University of Michigan
Ann Arbor
Great Lakes Research Group, Inc.
Bay City
Revive Research Institute
Farmington Hills
Revival Research Institute
Sterling Heights
Missouri
Bio-Kinetic Clinical Applications, LLC
Springfield
Mississippi
Sky Clinical Prime and Health Wellness Clinic
Fayette
Olive Branch Family Medical Center
Olive Branch
Sky Clin Resch - Quinn HC
Ridgeland
North Carolina
Onsite Clinical Solutions, LLC
Charlotte
East Carolina University
Greenville
Monroe Biomed Research
Monroe
Carteret Medical Group
Morehead City
PMG Research of Wilmington
Wilmington
Nebraska
Quality Clinical Research
Omaha
New Jersey
Holy Name Medical Center
Teaneck
Nevada
Excel Clinical Research
Las Vegas
Las Vegas Medical Research
Las Vegas
SVG Clinical
Las Vegas
New York
Prime Global Research, LLC
Bronx
Ohio
Valley Medical Primary Care
Centerville
Hometown UC and Rch- Cincy
Cincinnati
Aventiv Research Inc
Columbus
Remington-Davis, Inc
Columbus
Urgent Care Specialists, LLC
Columbus
META Medical Research Institute
Dayton
Urgent Care Specialists, LLC
Dayton
Oklahoma
Ascension St. John Tulsa OK
Tulsa
Pennsylvania
Children's Hospital of Philadelphia
Philadelphia
Jefferson Hosp for Neurosci
Philadelphia
Temple University Hospital
Philadelphia
South Carolina
VITALINK - Anderson
Anderson
Carolina Medical Research - Clinton
Clinton
VITALINK - Gaffney
Gaffney
Carolina Medical Research - Greenville
Greenville
VITALINK - Greenville
Greenville
VITALINK - Spartanburg
Spartanburg
VITALINK - Union
Union
Tennessee
Univ Diab & Endo Consult
Chattanooga
New Phase Research and Development
Knoxville
Texas
Gadolin Research, LLC
Beaumont
Conroe Willis Medical Research
Conroe
Crossroads Clinical Research
Corpus Christi
B S & W Med Center
Dallas
Baylor - Fort Worth
Fort Worth
North Texas Clinical Trials, LLC
Fort Worth
1960 Family Practice, PA
Houston
Accurate Clinical Management, LLC.
Houston
Houston Methodist Research Ins
Houston
Next Level Urgent Care
Houston
B S & W Med Center
Irving
Zion Urgent Care Clinic
Katy
BioPharma Family Practice Center McAllen
Mcallen
BRCR Medical Center, Inc
Mcallen
North Hills Medical Research
North Richland Hills
Bay Area Infectious Diseases Associates
Pasadena
Epic Medical Research
Red Oak
Baylor - Round Rock
Round Rock
Sun Research Institute
San Antonio
Consano Clinical Research, LLC
Shavano Park
APD Clinical Research
Splendora
Crossroads Clin Rch-Victoria
Victoria
CLS Research Ctr, PLLC
Webster
Virginia
CARE ID
Annandale
Washington
Evergreen Health Research
Kirkland
Other Locations
Argentina
Sanatorio de la Trinidad Mitre
Caba
Clínica Zabala
Ciudad De Buenos Aires
Sanatorio Sagrado Corazón
Ciudad De Buenos Aires
Hospital San Roque
Cordoba
Clínica Privada Independencia
Munro
Instituto Médico Rio Cuarto
Rio Cuarto
INECO Neurociencias Oroño
Rosario
Go Centro Medico San Nicolás
San Nicolás
Centro de Investigaciones Clínicas - Clínica Viedma
Viedma
Clinica Central S.A.
Villa Regina
Instituto de Investigaciones Clinicas Zarate
Zárate
Puerto Rico
Advanced Clinical Research, LLC
Bayamon
Dorado Medical Complex Inc
Dorado
GCM Medical Group, PSC - Hato Rey Site
San Juan
Time Frame
Start Date: 2020-10-29
Completion Date: 2021-10-18
Participants
Target number of participants: 1755
Treatments
Placebo_comparator: Placebo (Pbo)
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.
Experimental: BAM + ETE
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.
Experimental: BAM
Treatment 5: 700 mg BAM administered IV.~700 mg BAM 15-min (Addendum (2)) administered IV.
Experimental: BAM + VIR-7831
Treatment 7: 700 mg BAM + 500 mg VIR-7831 (Amendment (C-e)) administered IV.
Experimental: BEB
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.
Experimental: BAM+ ETE + BEB
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.
Authors
David Della Lana, Nancy Patel, James Melton, Katherine Belden, Carla McWilliams, Yessica Sachdeva, Michael Winnie, Victor Escobar, Husam Issa, Arin Piramzadian, Jason Morris, Duane Anderson, Steven Zeig, James Winn, Corey Hebert, Sandro Bacchelli, Kevin D Cannon, Omesh Verma, Ramesh Nathan, Paul P Cook, Roxana Stoici, Angel Luis Comulada-Rivera, David Schultz, Jalal Abbas, Awawu Igbinadolor, Wilner E. Jeudy, Rubaba Hussain, Christopher Sartore, Kenneth Kim, Alon Antebi, David Huffman, Thomas Fiel, R. Gentry Wilkerson, Kristin Highland, Gregorio A. Cortes-Maisonet, Steve Choi, Nader Sobh, Marilyn Glassberg, Bharat R Mocherla, Jeffrey A. Potts, John Gabriel, David Kimberlin, Barry Feldman, Patrick Weston, Masoud Azizad, Robert Perry, Suraj Saggar, GERARD J CRINER, Mary Katherine Lawrence, David Pitrak, Bhaktasharan Patel, Robert Gottlieb, Manuel Sanchez, Blaise Gatto, Jonathan Schimmel, Kenneth Steil, Princy Kumar, Evelyne M Davidson, Adam Schwartz, Carl Dukes, Carl D Vance, Gregory Feldman, Jeffrey K Kingsley, Brian Zeno, Randall Toombs Huling, Peter Chen, Tewodros Teketel, Chad Crystal, Anita Kohli, Howard Huang, Kayce Morton, Jose Pinero, Jason Ahn, Lilia Roque-Guerrero, Dwight D Blake, Guenther Koehne, David Wheeler, Najmuddin Karimjee, Kevin D Roberts, Adil Fatakia, Priyesh Mehta, Hessam Aazami, Francisco Delgado, David Erb, Joshua Michael Purow, Zeid Kayali, Abdulhassan Saad, Hamid Bassiri, Olayemi Osiyemi, Michael Dunn, Roman Tavarez, William Muller, James Krainson, Anuj Malik, Ravikumar Patel, Barry Heller, Jose F Cardona, Aramis Cosme, Bhavna Malik, Vijay Goli, Andra Blomkalns, Yevgeniy Bukhman, Alexander E. Osowa, James B Hall, Cynthia C Brinson, Joseph Boscia, Timothy S. Bailey, Zaher Shebib, Paul Carlton Norwood, Owen Albin, Lee Wilbur, Aaron Kinney, Meenakshi C Patel, Joseph Surber, Michael L Dougan, Faisal Amin
Sponsors
Collaborators: Shanghai Junshi Bioscience Co., Ltd., Vir Biotechnology, Inc., AbCellera Biologics Inc., GlaxoSmithKline
Leads: Eli Lilly and Company

This content was sourced from clinicaltrials.gov