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.
Drug: Bamlanivimab
Administered IV.
Other Name: Array
Drug: Etesevimab
Administered IV.
Other Name: Array
Drug: Placebo
Administered IV.
Drug: VIR-7831
Administered IV.
Other Name: GSK4182136
Drug: Bebtelovimab
Administered IV.
Other Name: LY-CoV1404, LY3853113
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
University of Alabama at Birmingham
Birmingham, Alabama, United States
The Institute for Liver Health
Mesa, Arizona, United States
Perseverance Research Center
Scottsdale, Arizona, United States
CRI of Arizona, LLC
Sun City West, Arizona, United States
Fiel Family and Sports Medicine PC
Tempe, Arizona, United States
The Institute for Liver Health
Tucson, Arizona, United States
KLR Business Group, Inc. dba Arkansas Clinical Research
Little Rock, Arkansas, United States
Applied Rsch Ctr - Arkansas Inc.
Little Rock, Arkansas, United States
Smart Cures Clin Research
Anaheim, California, United States
Hope Clinical Research
Canoga Park, California, United States
VCT-Covina
Covina, California, United States
Neighborhood Healthcare
Escondido, California, United States
Chemidox Clinical Trials
Lancaster, California, United States
Ark Clinical Research
Long Beach, California, United States
Long Beach Clinical Trials LLC
Long Beach, California, United States
Cedars Sinai Medical Center
Los Angeles, California, United States
Central Valley Research, LLC
Modesto, California, United States
Inland Empire Liver Foundation
Rialto, California, United States
Sutter Institute For Medical Research
Sacramento, California, United States
Wolverine Clinical Trials, LLC
Santa Ana, California, United States
St. Joe Heritage HC-Santa Rosa
Santa Rosa, California, United States
Stanford University Hospital
Stanford, California, United States
Mazur, Statner, Dutta, Nathan
Thousand Oaks, California, United States
South Bay Clinical Research Institute
Torrance, California, United States
Infect Disease Doctors Med Grp
Walnut Creek, California, United States
Allianz Research Institute
Westminster, California, United States
Future Innovative Treatments LLC
Colorado Springs, Colorado, United States
Georgetown Univ Sch of Med
Washington, District of Columbia, United States
Synergy Healthcare LLC
Bradenton, Florida, United States
Holy Cross Hospital Inc.
Fort Lauderdale, Florida, United States
I R & Health Center, Inc.
Hialeah, Florida, United States
Encore Medical Research
Hollywood, Florida, United States
Elixia CRC
Hollywood, Florida, United States
Lakeland Regional Medical Center
Lakeland, Florida, United States
Panax Clinical Research
Miami Lakes, Florida, United States
Hope Clinical Trials, Inc.
Miami, Florida, United States
Miami Cancer Institute at Baptist Health, Inc.
Miami, Florida, United States
Bio-Medical Research, LLC
Miami, Florida, United States
Clinical Site Partners, LLC d/b/a CSP Miami
Miami, Florida, United States
Testing Matters Lab
Sunrise, Florida, United States
Advent Health Tampa
Tampa, Florida, United States
Triple O Research Inst
West Palm Beach, Florida, United States
Encore Medical Research - Weston
Weston, Florida, United States
Clinical Site Partners, LLC DBA CSP Orlando
Winter Park, Florida, United States
Gwinnett Research Inst
Buford, Georgia, United States
Paramount Rch Sol - College Pk
College Park, Georgia, United States
IACT Health - VHC
Columbus, Georgia, United States
Central Georgia Infectious Disease
Macon, Georgia, United States
Rophe Adult and Pediatric Medicine
Union City, Georgia, United States
Rocky Mountain Clinical Research
Idaho Falls, Idaho, United States
Ann & Robert H Lurie Children's Hospital of Chicago
Chicago, Illinois, United States
Great Lakes Clinical Trials
Chicago, Illinois, United States
Franciscan Health Hammond
Dyer, Indiana, United States
Qualmedica Research Evansville
Evansville, Indiana, United States
Franciscan St. Francis Health
Indianapolis, Indiana, United States
St.Vincent - Indy
Indianapolis, Indiana, United States
Qualmedica Research, LLC
Owensboro, Kentucky, United States
Tandem Clinical Research,LLC
Marrero, Louisiana, United States
Imperial Health Urgent Care Center - Moss Bluff
Moss Bluff, Louisiana, United States
Nola Research Works, LLC
New Orleans, Louisiana, United States
University of Maryland Medical Center
Baltimore, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
U of MA Mem Med Ctr
Worcester, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
Great Lakes Research Group, Inc.
Bay City, Michigan, United States
Revive Research Institute
Farmington Hills, Michigan, United States
Revival Research Institute
Sterling Heights, Michigan, United States
Sky Clinical Prime and Health Wellness Clinic
Fayette, Mississippi, United States
Olive Branch Family Medical Center
Olive Branch, Mississippi, United States
Sky Clin Resch - Quinn HC
Ridgeland, Mississippi, United States
Bio-Kinetic Clinical Applications, LLC
Springfield, Missouri, United States
Quality Clinical Research
Omaha, Nebraska, United States
Excel Clinical Research
Las Vegas, Nevada, United States
Las Vegas Medical Research
Las Vegas, Nevada, United States
SVG Clinical
Las Vegas, Nevada, United States
Holy Name Medical Center
Teaneck, New Jersey, United States
Prime Global Research, LLC
Bronx, New York, United States
Onsite Clinical Solutions, LLC
Charlotte, North Carolina, United States
East Carolina University
Greenville, North Carolina, United States
Monroe Biomed Research
Monroe, North Carolina, United States
Carteret Medical Group
Morehead City, North Carolina, United States
PMG Research of Wilmington
Wilmington, North Carolina, United States
Valley Medical Primary Care
Centerville, Ohio, United States
Hometown UC and Rch- Cincy
Cincinnati, Ohio, United States
Aventiv Research Inc
Columbus, Ohio, United States
Urgent Care Specialists, LLC
Columbus, Ohio, United States
Remington-Davis, Inc
Columbus, Ohio, United States
Urgent Care Specialists, LLC
Dayton, Ohio, United States
META Medical Research Institute
Dayton, Ohio, United States
Ascension St. John Tulsa OK
Tulsa, Oklahoma, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Jefferson Hosp for Neurosci
Philadelphia, Pennsylvania, United States
Temple University Hospital
Philadelphia, Pennsylvania, United States
VITALINK - Anderson
Anderson, South Carolina, United States
Carolina Medical Research - Clinton
Clinton, South Carolina, United States
VITALINK - Gaffney
Gaffney, South Carolina, United States
Carolina Medical Research - Greenville
Greenville, South Carolina, United States
VITALINK - Greenville
Greenville, South Carolina, United States
VITALINK - Spartanburg
Spartanburg, South Carolina, United States
VITALINK - Union
Union, South Carolina, United States
Univ Diab & Endo Consult
Chattanooga, Tennessee, United States
New Phase Research and Development
Knoxville, Tennessee, United States
Gadolin Research, LLC
Beaumont, Texas, United States
Conroe Willis Medical Research
Conroe, Texas, United States
Crossroads Clinical Research
Corpus Christi, Texas, United States
B S & W Med Center
Dallas, Texas, United States
Baylor - Fort Worth
Fort Worth, Texas, United States
North Texas Clinical Trials, LLC
Fort Worth, Texas, United States
Houston Methodist Research Ins
Houston, Texas, United States
Next Level Urgent Care
Houston, Texas, United States
Accurate Clinical Management, LLC.
Houston, Texas, United States
1960 Family Practice, PA
Houston, Texas, United States
B S & W Med Center
Irving, Texas, United States
Zion Urgent Care Clinic
Katy, Texas, United States
BioPharma Family Practice Center McAllen
McAllen, Texas, United States
BRCR Medical Center, Inc
McAllen, Texas, United States
North Hills Medical Research
North Richland Hills, Texas, United States
Bay Area Infectious Diseases Associates
Pasadena, Texas, United States
Epic Medical Research
Red Oak, Texas, United States
Baylor - Round Rock
Round Rock, Texas, United States
Sun Research Institute
San Antonio, Texas, United States
Consano Clinical Research, LLC
Shavano Park, Texas, United States
APD Clinical Research
Splendora, Texas, United States
Crossroads Clin Rch-Victoria
Victoria, Texas, United States
CLS Research Ctr, PLLC
Webster, Texas, United States
CARE ID
Annandale, Virginia, United States
Evergreen Health Research
Kirkland, Washington, United States
Sanatorio Sagrado Corazón
Ciudad de Buenos Aires, AR, Argentina
Clínica Zabala
Ciudad de Buenos Aires, AR, Argentina
Sanatorio de la Trinidad Mitre
Caba, Buenos Aires, Argentina
Clínica Privada Independencia
Munro, Buenos Aires, Argentina
Go Centro Medico San Nicolás
San Nicolás, Buenos Aires, Argentina
Instituto de Investigaciones Clinicas Zarate
Zárate, Buenos Aires, Argentina
Instituto Médico Rio Cuarto
Rio Cuarto, Cordoba, Argentina
Clinica Central S.A.
Villa Regina, Rio Negro, Argentina
Centro de Investigaciones Clínicas - Clínica Viedma
Viedma, RN, Argentina
INECO Neurociencias Oroño
Rosario, Santa Fe, Argentina
Hospital San Roque
Cordoba, Argentina
Advanced Clinical Research, LLC
Bayamon, Puerto Rico
Dorado Medical Complex Inc
Dorado, Puerto Rico
GCM Medical Group, PSC - Hato Rey Site
San Juan, Puerto Rico
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