A Study of Immune System Proteins in Participants With Mild to Moderate COVID-19 Illness

Last updated: June 7, 2022
Sponsor: Eli Lilly and Company
Overall Status: Completed

Phase

2

Condition

Covid-19

Treatment

N/A

Clinical Study ID

NCT04634409
18160
J2X-MC-PYAH
  • Ages > 12
  • All Genders

Study 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 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

Total Participants: 1755
Study Start date:
October 29, 2020
Estimated Completion Date:
October 18, 2021

Connect with a study center

  • Clínica Zabala

    Ciudad de Buenos Aires, AR C1426AAM
    Argentina

    Site Not Available

  • Sanatorio Sagrado Corazón

    Ciudad de Buenos Aires, AR C1039AAC
    Argentina

    Site Not Available

  • Sanatorio de la Trinidad Mitre

    Caba, Buenos Aires C1039AAO
    Argentina

    Site Not Available

  • Clínica Privada Independencia

    Munro, Buenos Aires
    Argentina

    Site Not Available

  • Go Centro Medico San Nicolás

    San Nicolás, Buenos Aires B2900DPA
    Argentina

    Site Not Available

  • Instituto de Investigaciones Clinicas Zarate

    Zarate, Buenos Aires 2800
    Argentina

    Site Not Available

  • Instituto de Investigaciones Clinicas Zarate

    Zárate, Buenos Aires 2800
    Argentina

    Site Not Available

  • Instituto Médico Rio Cuarto

    Rio Cuarto, Cordoba X5800AEV
    Argentina

    Site Not Available

  • Centro de Investigaciones Clínicas - Clínica Viedma

    Viedma, RN 8500
    Argentina

    Site Not Available

  • Clinica Central S.A.

    Villa Regina, Rio Negro R8336
    Argentina

    Site Not Available

  • INECO Neurociencias Oroño

    Rosario, Santa Fe S2000
    Argentina

    Site Not Available

  • Hospital San Roque

    Cordoba, 5000
    Argentina

    Site Not Available

  • Advanced Clinical Research, LLC

    Bayamon, 00961
    Puerto Rico

    Site Not Available

  • Dorado Medical Complex Inc

    Dorado, 00646
    Puerto Rico

    Site Not Available

  • Puerto Rico Medical Research Center

    Hato Rey, 00917
    Puerto Rico

    Site Not Available

  • GCM Medical Group, PSC - Hato Rey Site

    San Juan, 00917
    Puerto Rico

    Site Not Available

  • University of Alabama at Birmingham

    Birmingham, Alabama 35233
    United States

    Site Not Available

  • The Institute for Liver Health

    Mesa, Arizona 85210
    United States

    Site Not Available

  • Banner Univ Med Ctr Phoenix

    Phoenix, Arizona 85006
    United States

    Site Not Available

  • Perseverance Research Center

    Scottsdale, Arizona 85254
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    Site Not Available

  • CRI of Arizona, LLC

    Sun City West, Arizona 85375
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  • CRI of Arizona, LLC

    Surprise, Arizona 85374
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    Site Not Available

  • Fiel Family and Sports Medicine PC

    Tempe, Arizona 85283
    United States

    Site Not Available

  • The Institute for Liver Health

    Tucson, Arizona 85712
    United States

    Site Not Available

  • Applied Rsch Ctr - Arkansas Inc.

    Little Rock, Arkansas 72212
    United States

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  • KLR Business Group, Inc. dba Arkansas Clinical Research

    Little Rock, Arkansas 72205
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  • Smart Cures Clin Research

    Anaheim, California 92806
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    Canoga Park, California 91303
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    Escondido, California 92025
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    Fresno, California 93720
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  • Ark Clinical Research

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  • Long Beach Clinical Trials LLC

    Long Beach, California 90806
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  • Cedars Sinai Medical Center

    Los Angeles, California 90048-5615
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  • Central Valley Research, LLC

    Modesto, California 95350
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  • Inland Empire Liver Foundation

    Rialto, California 92377
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  • Sutter Institute For Medical Research

    Sacramento, California 95816
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  • Zion Medical Center

    San Diego, California 92120
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  • Wolverine Clinical Trials, LLC

    Santa Ana, California 92705
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  • St. Joe Heritage HC-Santa Rosa

    Santa Rosa, California 95405
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  • Stanford University Hospital

    Stanford, California 94305
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  • Mazur, Statner, Dutta, Nathan

    Thousand Oaks, California 91360
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  • South Bay Clinical Research Institute

    Torrance, California 90503
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  • Infect Disease Doctors Med Grp

    Walnut Creek, California 94598
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  • Allianz Research Institute

    Westminster, California 92683
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  • Future Innovative Treatments LLC

    Colorado Springs, Colorado 80907
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  • Georgetown Univ Sch of Med

    Washington, District of Columbia 20007
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  • Synergy Healthcare LLC

    Bradenton, Florida 34208
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    Site Not Available

  • Holy Cross Hospital Inc.

    Fort Lauderdale, Florida 33308
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  • I R & Health Center, Inc.

    Hialeah, Florida 33012
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  • Elixia CRC

    Hollywood, Florida 33023
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  • Encore Medical Research

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  • Lakeland Regional Medical Center

    Lakeland, Florida 33804
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  • Bio-Medical Research, LLC

    Miami, Florida 33184
    United States

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  • Clinical Site Partners, LLC d/b/a CSP Miami

    Miami, Florida 33186
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  • Hope Clinical Trials, Inc.

    Miami, Florida 33165
    United States

    Site Not Available

  • Miami Cancer Institute at Baptist Health, Inc.

    Miami, Florida 33176
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  • Panax Clinical Research

    Miami Lakes, Florida 33014
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    Site Not Available

  • GCPR

    Saint Petersburg, Florida 33702
    United States

    Site Not Available

  • Testing Matters Lab

    Sunrise, Florida 33325
    United States

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  • Advent Health Tampa

    Tampa, Florida 33613
    United States

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  • Triple O Research Inst

    West Palm Beach, Florida 33407
    United States

    Site Not Available

  • Encore Medical Research - Weston

    Weston, Florida 33331
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  • Clinical Site Partners, LLC DBA CSP Orlando

    Winter Park, Florida 32789
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    Site Not Available

  • Gwinnett Research Inst

    Buford, Georgia 30519
    United States

    Site Not Available

  • Paramount Rch Sol - College Pk

    College Park, Georgia 30349
    United States

    Site Not Available

  • IACT Health - VHC

    Columbus, Georgia 31904
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  • Central Georgia Infectious Disease

    Macon, Georgia 31201
    United States

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  • Rophe Adult and Pediatric Medicine

    Union City, Georgia 30291
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  • Rocky Mountain Clinical Research

    Idaho Falls, Idaho 83404
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  • Ann & Robert H Lurie Children's Hospital of Chicago

    Chicago, Illinois 60611
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  • Great Lakes Clinical Trials

    Chicago, Illinois 60640
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  • Franciscan Health Hammond

    Dyer, Indiana 46311
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  • Qualmedica Research Evansville

    Evansville, Indiana 47715
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  • Franciscan St. Francis Health

    Indianapolis, Indiana 46237
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  • St.Vincent - Indy

    Indianapolis, Indiana 46260
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  • Qualmedica Research, LLC

    Owensboro, Kentucky 42301
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  • Tandem Clinical Research,LLC

    Marrero, Louisiana 70072
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  • Imperial Health Urgent Care Center - Moss Bluff

    Moss Bluff, Louisiana 70611
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  • Nola Research Works, LLC

    New Orleans, Louisiana 70125
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    Site Not Available

  • University of Maryland Medical Center

    Baltimore, Maryland 21201
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    Site Not Available

  • Massachusetts General Hospital

    Boston, Massachusetts 02114
    United States

    Site Not Available

  • U of MA Mem Med Ctr

    Worcester, Massachusetts 01605
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    Site Not Available

  • University of Michigan

    Ann Arbor, Michigan 48109
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    Site Not Available

  • Great Lakes Research Group, Inc.

    Bay City, Michigan 48706
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  • Revive Research Institute

    Farmington Hills, Michigan 48334
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  • Revival Research Institute

    Sterling Heights, Michigan 48312
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  • Sky Clinical Prime and Health Wellness Clinic

    Fayette, Mississippi 39069
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  • Olive Branch Family Medical Center

    Olive Branch, Mississippi 38654
    United States

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  • Sky Clin Resch - Quinn HC

    Ridgeland, Mississippi 39157
    United States

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  • Bio-Kinetic Clinical Applications, LLC

    Springfield, Missouri 65802
    United States

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  • Quality Clinical Research

    Omaha, Nebraska 68114
    United States

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  • Excel Clinical Research

    Las Vegas, Nevada 89109
    United States

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  • Las Vegas Medical Research

    Las Vegas, Nevada 89113
    United States

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  • SVG Clinical

    Las Vegas, Nevada 89128
    United States

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  • Holy Name Medical Center

    Teaneck, New Jersey 07666
    United States

    Site Not Available

  • Prime Global Research, LLC

    Bronx, New York 10456
    United States

    Site Not Available

  • Icahn Sch of Med at Mt. Sinai

    New York, New York 10029
    United States

    Site Not Available

  • University of North Carolina

    Chapel Hill, North Carolina 27599
    United States

    Site Not Available

  • Onsite Clinical Solutions, LLC

    Charlotte, North Carolina 28226
    United States

    Site Not Available

  • East Carolina University

    Greenville, North Carolina 27834
    United States

    Site Not Available

  • Monroe Biomed Research

    Monroe, North Carolina 28112
    United States

    Site Not Available

  • Carteret Medical Group

    Morehead City, North Carolina 28557
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    Site Not Available

  • PMG Research of Wilmington

    Wilmington, North Carolina 28401
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    Site Not Available

  • Valley Medical Primary Care

    Centerville, Ohio 45459
    United States

    Site Not Available

  • Hometown UC and Rch- Cincy

    Cincinnati, Ohio 45215
    United States

    Site Not Available

  • Cleveland Clinic Foundation

    Cleveland, Ohio 44195
    United States

    Site Not Available

  • Aventiv Research Inc

    Columbus, Ohio 43213
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    Site Not Available

  • Remington-Davis, Inc

    Columbus, Ohio 43215
    United States

    Site Not Available

  • Urgent Care Specialists, LLC

    Columbus, Ohio 43214
    United States

    Site Not Available

  • META Medical Research Institute

    Dayton, Ohio 45432
    United States

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  • Urgent Care Specialists, LLC

    Dayton, Ohio 45424
    United States

    Site Not Available

  • Ascension St. John Tulsa OK

    Tulsa, Oklahoma 74104
    United States

    Site Not Available

  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania 18901
    United States

    Site Not Available

  • Jefferson Hosp for Neurosci

    Philadelphia, Pennsylvania 19107
    United States

    Site Not Available

  • Temple University Hospital

    Philadelphia, Pennsylvania 19140
    United States

    Site Not Available

  • VITALINK - Anderson

    Anderson, South Carolina 29621
    United States

    Site Not Available

  • Carolina Medical Research - Clinton

    Clinton, South Carolina 29325
    United States

    Site Not Available

  • VITALINK - Gaffney

    Gaffney, South Carolina 29340
    United States

    Site Not Available

  • Carolina Medical Research - Greenville

    Greenville, South Carolina 29607
    United States

    Site Not Available

  • VITALINK - Greenville

    Greenville, South Carolina 29615
    United States

    Site Not Available

  • VITALINK - Spartanburg

    Spartanburg, South Carolina 29303
    United States

    Site Not Available

  • VITALINK - Union

    Union, South Carolina 29379
    United States

    Site Not Available

  • Univ Diab & Endo Consult

    Chattanooga, Tennessee 37411
    United States

    Site Not Available

  • New Phase Research and Development

    Knoxville, Tennessee 37909
    United States

    Site Not Available

  • Central Texas Clinical Rch

    Austin, Texas 78705
    United States

    Site Not Available

  • Gadolin Research, LLC

    Beaumont, Texas 77702
    United States

    Site Not Available

  • Conroe Willis Medical Research

    Conroe, Texas 77304
    United States

    Site Not Available

  • Crossroads Clinical Research

    Corpus Christi, Texas 78413
    United States

    Site Not Available

  • B S & W Med Center

    Dallas, Texas 75246
    United States

    Site Not Available

  • Baylor - Fort Worth

    Fort Worth, Texas 76104
    United States

    Site Not Available

  • North Texas Clinical Trials, LLC

    Fort Worth, Texas 76104
    United States

    Site Not Available

  • 1960 Family Practice, PA

    Houston, Texas 77090
    United States

    Site Not Available

  • Accurate Clinical Management, LLC.

    Houston, Texas 77065
    United States

    Site Not Available

  • Houston Methodist Research Ins

    Houston, Texas 77030
    United States

    Site Not Available

  • Next Level Urgent Care

    Houston, Texas 77057
    United States

    Site Not Available

  • B S & W Med Center

    Irving, Texas 75061
    United States

    Site Not Available

  • Zion Urgent Care Clinic

    Katy, Texas 77494
    United States

    Site Not Available

  • BRCR Medical Center, Inc

    McAllen, Texas 78501
    United States

    Site Not Available

  • BioPharma Family Practice Center McAllen

    McAllen, Texas 78501
    United States

    Site Not Available

  • North Hills Medical Research

    North Richland Hills, Texas 76180
    United States

    Site Not Available

  • Bay Area Infectious Diseases Associates

    Pasadena, Texas 77505
    United States

    Site Not Available

  • Epic Medical Research

    Red Oak, Texas 75154
    United States

    Site Not Available

  • Baylor - Round Rock

    Round Rock, Texas 78665
    United States

    Site Not Available

  • Sun Research Institute

    San Antonio, Texas 78215
    United States

    Site Not Available

  • Consano Clinical Research, LLC

    Shavano Park, Texas 78231
    United States

    Site Not Available

  • APD Clinical Research

    Splendora, Texas 77372
    United States

    Site Not Available

  • Crossroads Clin Rch-Victoria

    Victoria, Texas 77901
    United States

    Site Not Available

  • CLS Research Ctr, PLLC

    Webster, Texas 77598
    United States

    Site Not Available

  • CARE ID

    Annandale, Virginia 22003
    United States

    Site Not Available

  • Evergreen Health Research

    Kirkland, Washington 98034
    United States

    Site Not Available

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