Phase
Condition
Covid-19
Treatment
N/AClinical Study ID
Ages > 12 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- For low-risk participant arms 9-11 only: Are greater than or equal to (≥)18 and lessthan (<)65 years of age at the time of randomization and do not have the risk factorsdefined 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 thetime 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 riskfactors at the time of screening
- Have a BMI ≥85th percentile for their age and gender based on CDC growthcharts, 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 thatrequires 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 thetime 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 ≥85thpercentile 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 pulmonaryhypertension)
- Have sickle cell disease
- Have neurodevelopmental disorder (for example, cerebral palsy) or other conditionsthat confer medical complexity (for example, genetic or metabolic syndromes and severecongenital 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 withexertion, nasal congestion or runny nose, new loss of smell, chills
- Must have sample taken for test confirming viral infection no more than 3 days priorto 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 consentand/or assent
Exclusion
Exclusion Criteria:
- For low-risk participants only: BMI ≥35
- Have oxygen saturation (SpO2) less than or equal to (≤)93 percent (%) on room air atsea level or ratio of arterial oxygen partial pressure (PaO2 in millimeters ofmercury) to fractional inspired oxygen (FiO2) <300, respiratory rate ≥30 per minute,heart rate ≥125 per minute
- Require mechanical ventilation or anticipated impending need for mechanicalventilation
- Have known allergies to any of the components used in the formulation of theinterventions
- Have hemodynamic instability requiring use of pressors within 24 hours ofrandomization
- Suspected or proven serious, active bacterial, fungal, viral, or other infection (besides COVID-19) that in the opinion of the investigator could constitute a riskwhen taking intervention
- Have any co-morbidity requiring surgery within <7 days, or that is consideredlife-threatening within 29 days
- Have any serious concomitant systemic disease, condition or disorder that, in theopinion 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 30days 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 aprevious SARS-CoV-2 vaccine study and are currently blinded to treatment allotment
- Have participated, within the last 30 days, in a clinical study involving aninvestigational intervention. If the previous investigational intervention has a longhalf-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 bescientifically 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 Design
Connect with a study center
Clínica Zabala
Ciudad de Buenos Aires, AR C1426AAM
ArgentinaSite Not Available
Sanatorio Sagrado Corazón
Ciudad de Buenos Aires, AR C1039AAC
ArgentinaSite Not Available
Sanatorio de la Trinidad Mitre
Caba, Buenos Aires C1039AAO
ArgentinaSite Not Available
Clínica Privada Independencia
Munro, Buenos Aires
ArgentinaSite Not Available
Go Centro Medico San Nicolás
San Nicolás, Buenos Aires B2900DPA
ArgentinaSite Not Available
Instituto de Investigaciones Clinicas Zarate
Zarate, Buenos Aires 2800
ArgentinaSite Not Available
Instituto de Investigaciones Clinicas Zarate
Zárate, Buenos Aires 2800
ArgentinaSite Not Available
Instituto Médico Rio Cuarto
Rio Cuarto, Cordoba X5800AEV
ArgentinaSite Not Available
Centro de Investigaciones Clínicas - Clínica Viedma
Viedma, RN 8500
ArgentinaSite Not Available
Clinica Central S.A.
Villa Regina, Rio Negro R8336
ArgentinaSite Not Available
INECO Neurociencias Oroño
Rosario, Santa Fe S2000
ArgentinaSite Not Available
Hospital San Roque
Cordoba, 5000
ArgentinaSite Not Available
Advanced Clinical Research, LLC
Bayamon, 00961
Puerto RicoSite Not Available
Dorado Medical Complex Inc
Dorado, 00646
Puerto RicoSite Not Available
Puerto Rico Medical Research Center
Hato Rey, 00917
Puerto RicoSite Not Available
GCM Medical Group, PSC - Hato Rey Site
San Juan, 00917
Puerto RicoSite Not Available
University of Alabama at Birmingham
Birmingham, Alabama 35233
United StatesSite Not Available
The Institute for Liver Health
Mesa, Arizona 85210
United StatesSite Not Available
Banner Univ Med Ctr Phoenix
Phoenix, Arizona 85006
United StatesSite Not Available
Perseverance Research Center
Scottsdale, Arizona 85254
United StatesSite Not Available
CRI of Arizona, LLC
Sun City West, Arizona 85375
United StatesSite Not Available
CRI of Arizona, LLC
Surprise, Arizona 85374
United StatesSite Not Available
Fiel Family and Sports Medicine PC
Tempe, Arizona 85283
United StatesSite Not Available
The Institute for Liver Health
Tucson, Arizona 85712
United StatesSite Not Available
Applied Rsch Ctr - Arkansas Inc.
Little Rock, Arkansas 72212
United StatesSite Not Available
KLR Business Group, Inc. dba Arkansas Clinical Research
Little Rock, Arkansas 72205
United StatesSite Not Available
Smart Cures Clin Research
Anaheim, California 92806
United StatesSite Not Available
Hope Clinical Research
Canoga Park, California 91303
United StatesSite Not Available
VCT-Covina
Covina, California 91723
United StatesSite Not Available
Neighborhood Healthcare
Escondido, California 92025
United StatesSite Not Available
Valley Research
Fresno, California 93720
United StatesSite Not Available
Chemidox Clinical Trials
Lancaster, California 93534
United StatesSite Not Available
Ark Clinical Research
Long Beach, California 90806
United StatesSite Not Available
Long Beach Clinical Trials LLC
Long Beach, California 90806
United StatesSite Not Available
Cedars Sinai Medical Center
Los Angeles, California 90048-5615
United StatesSite Not Available
Central Valley Research, LLC
Modesto, California 95350
United StatesSite Not Available
Inland Empire Liver Foundation
Rialto, California 92377
United StatesSite Not Available
Sutter Institute For Medical Research
Sacramento, California 95816
United StatesSite Not Available
Zion Medical Center
San Diego, California 92120
United StatesSite Not Available
Wolverine Clinical Trials, LLC
Santa Ana, California 92705
United StatesSite Not Available
St. Joe Heritage HC-Santa Rosa
Santa Rosa, California 95405
United StatesSite Not Available
Stanford University Hospital
Stanford, California 94305
United StatesSite Not Available
Mazur, Statner, Dutta, Nathan
Thousand Oaks, California 91360
United StatesSite Not Available
South Bay Clinical Research Institute
Torrance, California 90503
United StatesSite Not Available
Infect Disease Doctors Med Grp
Walnut Creek, California 94598
United StatesSite Not Available
Allianz Research Institute
Westminster, California 92683
United StatesSite Not Available
Future Innovative Treatments LLC
Colorado Springs, Colorado 80907
United StatesSite Not Available
Georgetown Univ Sch of Med
Washington, District of Columbia 20007
United StatesSite Not Available
Synergy Healthcare LLC
Bradenton, Florida 34208
United StatesSite Not Available
Holy Cross Hospital Inc.
Fort Lauderdale, Florida 33308
United StatesSite Not Available
I R & Health Center, Inc.
Hialeah, Florida 33012
United StatesSite Not Available
Elixia CRC
Hollywood, Florida 33023
United StatesSite Not Available
Encore Medical Research
Hollywood, Florida 33021
United StatesSite Not Available
Lakeland Regional Medical Center
Lakeland, Florida 33804
United StatesSite Not Available
Bio-Medical Research, LLC
Miami, Florida 33184
United StatesSite Not Available
Clinical Site Partners, LLC d/b/a CSP Miami
Miami, Florida 33186
United StatesSite Not Available
Hope Clinical Trials, Inc.
Miami, Florida 33165
United StatesSite Not Available
Miami Cancer Institute at Baptist Health, Inc.
Miami, Florida 33176
United StatesSite Not Available
Panax Clinical Research
Miami Lakes, Florida 33014
United StatesSite Not Available
GCPR
Saint Petersburg, Florida 33702
United StatesSite Not Available
Testing Matters Lab
Sunrise, Florida 33325
United StatesSite Not Available
Advent Health Tampa
Tampa, Florida 33613
United StatesSite Not Available
Triple O Research Inst
West Palm Beach, Florida 33407
United StatesSite Not Available
Encore Medical Research - Weston
Weston, Florida 33331
United StatesSite Not Available
Clinical Site Partners, LLC DBA CSP Orlando
Winter Park, Florida 32789
United StatesSite Not Available
Gwinnett Research Inst
Buford, Georgia 30519
United StatesSite Not Available
Paramount Rch Sol - College Pk
College Park, Georgia 30349
United StatesSite Not Available
IACT Health - VHC
Columbus, Georgia 31904
United StatesSite Not Available
Central Georgia Infectious Disease
Macon, Georgia 31201
United StatesSite Not Available
Rophe Adult and Pediatric Medicine
Union City, Georgia 30291
United StatesSite Not Available
Rocky Mountain Clinical Research
Idaho Falls, Idaho 83404
United StatesSite Not Available
Ann & Robert H Lurie Children's Hospital of Chicago
Chicago, Illinois 60611
United StatesSite Not Available
Great Lakes Clinical Trials
Chicago, Illinois 60640
United StatesSite Not Available
Franciscan Health Hammond
Dyer, Indiana 46311
United StatesSite Not Available
Qualmedica Research Evansville
Evansville, Indiana 47715
United StatesSite Not Available
Franciscan St. Francis Health
Indianapolis, Indiana 46237
United StatesSite Not Available
St.Vincent - Indy
Indianapolis, Indiana 46260
United StatesSite Not Available
Qualmedica Research, LLC
Owensboro, Kentucky 42301
United StatesSite Not Available
Tandem Clinical Research,LLC
Marrero, Louisiana 70072
United StatesSite Not Available
Imperial Health Urgent Care Center - Moss Bluff
Moss Bluff, Louisiana 70611
United StatesSite Not Available
Nola Research Works, LLC
New Orleans, Louisiana 70125
United StatesSite Not Available
University of Maryland Medical Center
Baltimore, Maryland 21201
United StatesSite Not Available
Massachusetts General Hospital
Boston, Massachusetts 02114
United StatesSite Not Available
U of MA Mem Med Ctr
Worcester, Massachusetts 01605
United StatesSite Not Available
University of Michigan
Ann Arbor, Michigan 48109
United StatesSite Not Available
Great Lakes Research Group, Inc.
Bay City, Michigan 48706
United StatesSite Not Available
Revive Research Institute
Farmington Hills, Michigan 48334
United StatesSite Not Available
Revival Research Institute
Sterling Heights, Michigan 48312
United StatesSite Not Available
Sky Clinical Prime and Health Wellness Clinic
Fayette, Mississippi 39069
United StatesSite Not Available
Olive Branch Family Medical Center
Olive Branch, Mississippi 38654
United StatesSite Not Available
Sky Clin Resch - Quinn HC
Ridgeland, Mississippi 39157
United StatesSite Not Available
Bio-Kinetic Clinical Applications, LLC
Springfield, Missouri 65802
United StatesSite Not Available
Quality Clinical Research
Omaha, Nebraska 68114
United StatesSite Not Available
Excel Clinical Research
Las Vegas, Nevada 89109
United StatesSite Not Available
Las Vegas Medical Research
Las Vegas, Nevada 89113
United StatesSite Not Available
SVG Clinical
Las Vegas, Nevada 89128
United StatesSite Not Available
Holy Name Medical Center
Teaneck, New Jersey 07666
United StatesSite Not Available
Prime Global Research, LLC
Bronx, New York 10456
United StatesSite Not Available
Icahn Sch of Med at Mt. Sinai
New York, New York 10029
United StatesSite Not Available
University of North Carolina
Chapel Hill, North Carolina 27599
United StatesSite Not Available
Onsite Clinical Solutions, LLC
Charlotte, North Carolina 28226
United StatesSite Not Available
East Carolina University
Greenville, North Carolina 27834
United StatesSite Not Available
Monroe Biomed Research
Monroe, North Carolina 28112
United StatesSite Not Available
Carteret Medical Group
Morehead City, North Carolina 28557
United StatesSite Not Available
PMG Research of Wilmington
Wilmington, North Carolina 28401
United StatesSite Not Available
Valley Medical Primary Care
Centerville, Ohio 45459
United StatesSite Not Available
Hometown UC and Rch- Cincy
Cincinnati, Ohio 45215
United StatesSite Not Available
Cleveland Clinic Foundation
Cleveland, Ohio 44195
United StatesSite Not Available
Aventiv Research Inc
Columbus, Ohio 43213
United StatesSite Not Available
Remington-Davis, Inc
Columbus, Ohio 43215
United StatesSite Not Available
Urgent Care Specialists, LLC
Columbus, Ohio 43214
United StatesSite Not Available
META Medical Research Institute
Dayton, Ohio 45432
United StatesSite Not Available
Urgent Care Specialists, LLC
Dayton, Ohio 45424
United StatesSite Not Available
Ascension St. John Tulsa OK
Tulsa, Oklahoma 74104
United StatesSite Not Available
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania 18901
United StatesSite Not Available
Jefferson Hosp for Neurosci
Philadelphia, Pennsylvania 19107
United StatesSite Not Available
Temple University Hospital
Philadelphia, Pennsylvania 19140
United StatesSite Not Available
VITALINK - Anderson
Anderson, South Carolina 29621
United StatesSite Not Available
Carolina Medical Research - Clinton
Clinton, South Carolina 29325
United StatesSite Not Available
VITALINK - Gaffney
Gaffney, South Carolina 29340
United StatesSite Not Available
Carolina Medical Research - Greenville
Greenville, South Carolina 29607
United StatesSite Not Available
VITALINK - Greenville
Greenville, South Carolina 29615
United StatesSite Not Available
VITALINK - Spartanburg
Spartanburg, South Carolina 29303
United StatesSite Not Available
VITALINK - Union
Union, South Carolina 29379
United StatesSite Not Available
Univ Diab & Endo Consult
Chattanooga, Tennessee 37411
United StatesSite Not Available
New Phase Research and Development
Knoxville, Tennessee 37909
United StatesSite Not Available
Central Texas Clinical Rch
Austin, Texas 78705
United StatesSite Not Available
Gadolin Research, LLC
Beaumont, Texas 77702
United StatesSite Not Available
Conroe Willis Medical Research
Conroe, Texas 77304
United StatesSite Not Available
Crossroads Clinical Research
Corpus Christi, Texas 78413
United StatesSite Not Available
B S & W Med Center
Dallas, Texas 75246
United StatesSite Not Available
Baylor - Fort Worth
Fort Worth, Texas 76104
United StatesSite Not Available
North Texas Clinical Trials, LLC
Fort Worth, Texas 76104
United StatesSite Not Available
1960 Family Practice, PA
Houston, Texas 77090
United StatesSite Not Available
Accurate Clinical Management, LLC.
Houston, Texas 77065
United StatesSite Not Available
Houston Methodist Research Ins
Houston, Texas 77030
United StatesSite Not Available
Next Level Urgent Care
Houston, Texas 77057
United StatesSite Not Available
B S & W Med Center
Irving, Texas 75061
United StatesSite Not Available
Zion Urgent Care Clinic
Katy, Texas 77494
United StatesSite Not Available
BRCR Medical Center, Inc
McAllen, Texas 78501
United StatesSite Not Available
BioPharma Family Practice Center McAllen
McAllen, Texas 78501
United StatesSite Not Available
North Hills Medical Research
North Richland Hills, Texas 76180
United StatesSite Not Available
Bay Area Infectious Diseases Associates
Pasadena, Texas 77505
United StatesSite Not Available
Epic Medical Research
Red Oak, Texas 75154
United StatesSite Not Available
Baylor - Round Rock
Round Rock, Texas 78665
United StatesSite Not Available
Sun Research Institute
San Antonio, Texas 78215
United StatesSite Not Available
Consano Clinical Research, LLC
Shavano Park, Texas 78231
United StatesSite Not Available
APD Clinical Research
Splendora, Texas 77372
United StatesSite Not Available
Crossroads Clin Rch-Victoria
Victoria, Texas 77901
United StatesSite Not Available
CLS Research Ctr, PLLC
Webster, Texas 77598
United StatesSite Not Available
CARE ID
Annandale, Virginia 22003
United StatesSite Not Available
Evergreen Health Research
Kirkland, Washington 98034
United StatesSite Not Available

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