BRII-198

An anti-SARS-CoV-2 monoclonal antibody.

Phase of research

Potential treatment - theoretical effect

How it helps

Antiviral

Drug status

Experimental

0
Supporting references
0
Contradictory references
1
AI-suggested references
6
Clinical trials

General information

BRII-198 and BRII-196 are modified non-competing anti-SARS-CoV-2 monoclonal antibodies. A formulation combining these two antibodies is clinically trialled for the treatment of mild or moderate COVID-19 (Evering et al., 2021). It was developed in collaboration with Brii Biosciences and some preliminary clinical trial data suggest its potential in reducing hospitalization and death in outpatients in high risk of clinical COVID-19 progression into a severe disease.

 


AI-suggested references

Clinical trials

ID Title Status Phase Start date Completion date
NCT04501978 ACTIV-3: Therapeutics for Inpatients With COVID-19 Active, not recruiting Phase 3 Aug/04/2020 Jul/01/2022
  • Alternative id - 014 / ACTIV-3
  • Interventions - Biological: LY3819253|Drug: Placebo|Biological: Remdesivir|Biological: VIR-7831|Biological: BRII-196/BRII-198|Biological: AZD7442|Drug: MP0420|Drug: PF-07304814
  • Study type - Interventional
  • Study results - No Results Available
  • Locations - Banner University Medical Center Tucson (Site 206-004), 1625 N. Campbell Avenue, Tucson, Arizona, United States|Southern Arizona VA Healthcare System (Site 074-009), 3601 S. 6th Ave., Tucson, Arizona, United States|Velocity Chula Vista (Site 080-034), 752 Medical Center Ct., Ste. 304, Chula Vista, California, United States|Community Regional Medical Center (Site 203-005), 2823 Fresno Street, Fresno, California, United States|Velocity San Diego (Site 080-035), 5565 Grossmont Center Drive, Building 2, Suite 1, La Mesa, California, United States|VA Loma Linda Healthcare System (Site 074-017), 11201 Benton Street, Loma Linda, California, United States|VA Long Beach Healthcare System (Site 074-026), 5901 East 7th Street (09/151-M2), Long Beach, California, United States|Keck Hospital of USC (Site 301-020), 1500 San Pablo Street, Los Angeles, California, United States|Cedars-Sinai Medical Center (Site 208-002), 8700 Beverly Blvd., Los Angeles, California, United States|Ronald Reagan UCLA Medical Center (Site 203-002), 757 Westwood Plaza, Los Angeles, California, United States|Sacramento VA Medical Center (Site 074-023), 10535 Hospital Way, Mather, California, United States|Hoag Memorial Hospital Presbyterian (Site 080-026), One Hoag Drive, Newport Beach, California, United States|Palo Alto VAMC (Site 074-005), 3801 Miranda Avenue, Palo Alto, California, United States|UC Davis Health (Site 203-004), 2315 Stockton Blvd., Sacramento, California, United States|VA San Diego Healthcare System (Site 074-016), 3350 La Jolla Village Drive, San Diego, California, United States|UCSF Medical Center at Mount Zion (Site 203-007), 1600 Divisadero St., San Francisco, California, United States|San Francisco VAMC (Site 074-002), 4150 Clement St., San Francisco, California, United States|UCSF Medical Center (Site 203-001), Moffitt-Long Hospital, 505 Parnassus Ave., San Francisco, California, United States|Stanford University Hospital & Clinics (Site 203-003), 300 Pasteur Dr., Stanford, California, United States|Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center (Site 066-002), 1124 W. Carson Street, CDCRC Building, Torrance, California, United States|University of Colorado Hospital (Site 204-001), 12605 E. 16th Avenue, Aurora, Colorado, United States|Denver Public Health (Site 017-004), 660 Bannock St., MC2600 (Infectious Disease Clinic), Denver, Colorado, United States|National Jewish Health / St. Joseph Hospital (Site 204-003), 1400 Jackson Street, Denver, Colorado, United States|West Haven VA Medical Center (Site 025-007), 950 Campbell Avenue, West Haven, Connecticut, United States|MedStar Georgetown University Hospital (Site 067-001), 3800 Reservoir Road NW, Washington, District of Columbia, United States|MedStar Health Research Institute (Site 009-021), MedStar Washington Hospital Center, 110 Irving St., NW., Washington, District of Columbia, United States|Washington DC VA Medical Center (Site 009-004), 50 Irving Street NW, Washington, District of Columbia, United States|Bay Pines VAMC (Site 074-004), 10000 Bay Pines Blvd., Bldg. 100, Room 5B-104, Bay Pines, Florida, United States|Baycare Health System (Site 301-025), Morton Plant Hospital, 300 Pinellas Street, Clearwater, Florida, United States|North Florida/South Georgia Veterans Health System (Site 074-011), 1601 SW. Archer Road, Gainesville, Florida, United States|Memorial Healthcare System (Site 648-002), Memorial Regional Hospital, 3501 Johnson Street, Hollywood, Florida, United States|Miami VAMC (Site 074-003), 1201 NW 16 Street, Miami, Florida, United States|Hillsborough County Health Department, University of South Florida (Site 032-001), Tampa, Florida, United States|Emory University (Site 301-008), The Emory Clinic, Bldg. A, Suite 2236, 1365 Clifton Rd., NE, Atlanta, Georgia, United States|Lutheran Medical Group (Site 301-010), 7916 W. Jefferson Boulevard, Fort Wayne, Indiana, United States|Cotton O'Neil Clinical Research Center (Site 080-030), Stormont Vail Health, 1500 SW 10th Avenue, Topeka, Kansas, United States|University of Kentucky Hospital (Site 210-004), 1000 South Limestone St., Lexington, Kentucky, United States|Ochsner Clinic Foundation (Site 301-015), 1514 Jefferson Highway, New Orleans, Louisiana, United States|University of Maryland Medical Center (Site 301-019), 22 South Greene Street, Baltimore, Maryland, United States|Massachusetts General Hospital (Site 202-002), 55 Fruit Street, Boston, Massachusetts, United States|Beth Israel Deaconess Medical Center (Site 202-001), 330 Brookline Ave., Boston, Massachusetts, United States|Baystate Medical Center (Site 201-001), 759 Chestnut Street, Springfield, Massachusetts, United States|University of Michigan (Site 205-001), 1500 East Medical Center Drive, Ann Arbor, Michigan, United States|Henry Ford Health System, Henry Ford Hospital (Site 014-001), 2799 W. Grand Blvd., Detroit, Michigan, United States|Minneapolis Heart Institute Foundation (Site 301-026), Abbott Northwestern Hospital, 920 E 28th St. #100, Minneapolis, Minnesota, United States|Hennepin Healthcare (Site 027-001), 701 Park Avenue, Minneapolis, Minnesota, United States|Minneapolis VA Health Care System (Site 105-001), 1 Veterans Drive, Bldg 70, Minneapolis, Minnesota, United States|M Health Fairview University of Minnesota Medical Center (Site 112-001), 500 Harvard St. SE., Minneapolis, Minnesota, United States|University of Mississippi Medical Center (Site 202-005), 2500 North State Street, Jackson, Mississippi, United States|VA St. Louis Healthcare System (Site 074-027), 915 North Grand Blvd., Rm. C201, Saint Louis, Missouri, United States|Dartmouth-Hitchcock Medical Center/Mary Hitchcock Memorial Hospital (Site 301-024), One Medical Center Drive, Lebanon, New Hampshire, United States|Cooper University Hospital (Site 019-001), One Cooper Plaza, Camden, New Jersey, United States|Lincoln Medical Center (New York Health and Hospitals/Lincoln) (Site 003-016), 234 E. 149th Street, Bronx, New York, United States|Montefiore Medical Center Weiler Hospital (Site 206-003), 1825 Eastchester Road, Bronx, New York, United States|Montefiore Medical Center Moses Hospital (Site 206-001), 111 E. 210th Street, Bronx, New York, United States|SUNY Downstate Medical Center (Site 033-001), 450 Clarkson Ave., Brooklyn, New York, United States|Maimonides Medical Center (Site 033-002), 4802 10th Avenue, Brooklyn, New York, United States|Ichan School of Medicine at Mount Sinai (Site 301-012), One Gustave L. Levy Place, Box 1620, New York, New York, United States|Duke University Hospital (Site 301-006), 2301 Erwin Road, Durham, North Carolina, United States|Wake Forest University Health Sciences (Site 210-001), Medical Center Blvd, Winston-Salem, North Carolina, United States|University of Cincinnati Medical Center (Site 207-003), 234 Goodman Ave., Cincinnati, Ohio, United States|University Hospitals Cleveland Medical Center (Site 108-001), 11100 Euclid Avenue, Cleveland, Ohio, United States|Cleveland Clinic Fairview Hospital (Site 207-005), 18101 Lorain Avenue, Cleveland, Ohio, United States|Cleveland Clinic Foundation (Site 207-001), 9500 Euclid Avenue, Cleveland, Ohio, United States|Cleveland Clinic Marymount Hospital (Site 207-006), 12300 McCraken Road, Garfield Heights, Ohio, United States|Oregon Health & Science University (Site 208-003), 3181 SW Sam Jackson Park Rd., Portland, Oregon, United States|Portland VA Healthcare System (Site 074-024), 3710 SW. US Veterans Hospital Road, Portland, Oregon, United States|UPMC Magee-Womens Hospital (Site 209-003), 300 Halket Street, Pittsburgh, Pennsylvania, United States|UPMC Presbyterian Hospital (Site 209-001), 200 Lothrop Street, Pittsburgh, Pennsylvania, United States|UPMC Shadyside Hospital (Site 209-005), 5230 Centre Avenue, Pittsburgh, Pennsylvania, United States|Rhode Island Hospital (Site 080-036), 593 Eddy Street, Providence, Rhode Island, United States|The Miriam Hospital (Site 080-039), 164 Summit Ave., Providence, Rhode Island, United States|VA Providence Healthcare System (Site 074-025), 830 Chalkstone Ave., Providence, Rhode Island, United States|Ralph H. Johnson VA Medical Center (Site 074-015), 109 Bee Street, Charleston, South Carolina, United States|MUSC Research Nexus Clinic (Site 210-002), 96 Jonathan Lucas St., CSB 214, Charleston, South Carolina, United States|MUSC Health Florence Medical Center (Site 210-006), 805 Pamplico Highway, Florence, South Carolina, United States|VA TVHS Nashville Campus (Site 074-022), 1310 24th Avenue South, Nashville, Tennessee, United States|Vanderbilt University Medical Center (Site 212-001), 1211 Medical Center Drive, Nashville, Tennessee, United States|Hendrick Medical Center (Site 080-014), 1900 Pine Street, Abilene, Texas, United States|CHRISTUS Spohn Shoreline Hospital (Site 080-001), 600 Elizabeth Street, Corpus Christi, Texas, United States|Parkland Health and Hospital Systems (Site 084-002), 5200 Harry Hines Blvd, Dallas, Texas, United States|UT Southwestern Medical Center (Site 084-001), 1936 Amelia Court, 2nd Floor, Dallas, Texas, United States|Baylor, Scott and White Health (Site 301-003), Baylor University Medical Center, 3500 Gaston Ave., Dallas, Texas, United States|Memorial Hermann Hospital (Site 203-006), 6411 Fannin Street, Houston, Texas, United States|Michael E. DeBakey Veterans Affairs Medical Center (MEDV AMC) (Site 074-006), 2002 Holcombe Blvd., Houston, Texas, United States|Texas Heart Institute (Site 301-017), 6770 Bertner, MC4-266, Houston, Texas, United States|CHRISTUS Good Shepherd Medical Center (Site 080-031), 700 E. Marshall Ave., Longview, Texas, United States|Intermountain Medical Center (Site 211-001), 5121 South Cottonwood Street, Murray, Utah, United States|University of Utah Hospital (Site 211-002), 419 Wakara Way, Suite 207, Salt Lake City, Utah, United States|LDS Hospital (Site 211-004), 8th Ave. C Street, Salt Lake City, Utah, United States|University of Virginia Health Systems (Site 301-021), 1215 Lee Street, Charlottesville, Virginia, United States|Virginia Commonwealth University Health System (Site 210-005), 1250 East Marshall Street, Richmond, Virginia, United States|Carilion Roanoke Memorial Hospital (Site 080-018), 1906 Belleview Avenue, Roanoke, Virginia, United States|Salem VA Medical Center (Site 074-014), 1970 Roanoke Blvd., Salem, Virginia, United States|Harborview Medical Center (Site 208-001), 325 9th Avenue, Seattle, Washington, United States|Swedish Hospital First Hill (Site 208-005), 747 Broadway, Seattle, Washington, United States|University of Washington Medical Center - Montlake (Site 208-006), 1959 NE Pacific Street, Seattle, Washington, United States|West Virginia University (Site 301-023), One Medical Center Drive, Morgantown, West Virginia, United States|Hospital Italiano de Buenos Aires (Site 611-002), Pres. Ttd. Gral. Juan Domingo Perón 4190, Buenos Aires, Argentina|Hospital General de Agudos Dr. JM Ramos Mejia (Site 611-001), Urquiza 609, Ciudad Autonoma de Buenos Aire, Argentina|Centro de Educación Médica e Investigaciones Clinicas "Norberto Quirno" CEMIC (Site 611-021), Av. Cnel. Díaz 2423 á, Ciudad Autonoma de Buenos Aire, Argentina|Aalborg Hospital (Site 625-005), Hobrovej 18, Aalborg, Denmark|Aarhus Universitetshospital, Skejby (Site 625-002), Department of Infectious Diseases, Palle Juul-Hensens Boulevard 99, Aarhus N, Denmark|Righospitalet (Site 625-006), Blegdamsvej 9,, Copenhagen Ø, Denmark|Bispebjerg Hospital (Site 625-013), Bispebjerg Bakke 23, Copenhagen, Denmark|Herlev/Gentofte Hospital (Site 625-012), Medicinsk Afdeling, Herlev Ringvej 75, Herlev, Denmark|Nordsjællands Hospital (Site 625-009), Dyrehavevej 29, Hillerød, Denmark|Hvidovre University Hospital, Department of Infectious Diseases (Site 625-001), Kettegård allé 30, Hvidovre, Denmark|Kolding Sygehus (Site 625-011), Medicinsk Afdeling, Sygehusvej 24, Kolding, Denmark|Odense University Hospital (Site 625-004), Infektionsmedicinsk Forskningsenhed, J.B. Winsløwsgade 4, Odense, Denmark|Zealand University Hospital, Roskilde (Site 625-010), Sygehusvej 10, Roskilde, Denmark|AIDS and Clinical Immunology Research Center (Site 627-201), Infectious Diseases, 16 Al. Kazbegi Avenue, Tbilisi, Georgia|Democritus University of Thrace (Site 635-021), University General Hospital of Alexandroupolis, Dragana, Alexandroupolis, Evros, Greece|Evangelismos COVID-19 Unit, (Site 635-020), 1st Dept. of Pulmonary and Critical Care Medicine, Evangelismos General Hospital, Dept., Ipsilantou 45-47, Athens, Greece|1st Respiratory Medicine Dept., Athens University Medical School (Site 635-015), Athens Hospital for Diseases of the Chest "Sotiria Hospital", 152 Mesogeion Ave., Athens, Greece|3rd Dept. of Medicine, Medical School, NKUA (Site 635-022), Sotiria General Hospital, 152 Mesogeion Ave., Athens, Greece|Attikon University General Hospital (Site 635-009), 4th Dept. of Internal Medicine, Medical School, National and Kapodistrian University of Athens, 1 Rimini St., Haidari, Athens, Greece|Chennai Antiviral Research and Treatment Clinical Research Site (Site 612-402), VHS-IDMC, Voluntary Health Services, Rajiv Gandhi Salai, Taramani, Chennai, Tamil Nadu, India|Medical Centre, Voluntary Health Services (Site 612-402), Rajiv Gandhi Salai, Taramani, Chennai, Tamil Nadu, India|Hospital General Dr. Aurelio Valdivieso (Site 653-004), Calzada Porfirio Díaz No. 400, Oaxaca de Juarez, Oaxaca, Mexico|Hospital General Dr. Manuel Gea González (Site 653-003), Av. Calzada de Tlalpan 4800, Colonia Belisario Domínguez Sec XVI Alcaldía Tlalpan, Mexico City, Mexico|Instituto Nacional de Ciencias Medicas y Nutrición Salvador Zubirán (Site 653-001), Av Vasco de Quiroga #15 Belisario Domínguez Secc XVI, Col. Belisario Domínguez Sección XVI, Alcaldía Tlalpan, Mexico City, Mexico|Instituto Nacional de Enfermedades Respiratorias "Ismael Cosío Villegas" (Site 653-002), Calzada de Tlapan No. 4502, Col. Belisario Domínguez Sección XVI Alcaldía Tlalpan, Mexico City, Mexico|Centro de Investigação e Treino em Saúde da Polana Caniço (CISPOC) (Site 634-701), Instituto Nacional de Saúde (INS), Rua da Costa do Sol, 178, Polana Caniço B, Maputo, Mozambique|Institute of Human Virology Nigeria (IHVN) (Site 612-601), Plot 252, Herbert Macaulay Way, Central Business District, Abuja, Nigeria|Wojewódzki Szpital Zakazny (Site 625-302), Wolska 37, Warsaw, Poland|Tan Tock Seng Hospital (Site 612-201), National Centre for Infectious Diseases (NCID), 11 Jalan Tan Tock Seng, Singapore, Singapore|Hospital Universitari Germans Trias i Pujol (Site 626-003), Infectious Disease Unit, Second Floor, Building Maternal, Road Canyet s/n, Badalona, Barcelona, Spain|Hospital Universitari Arnau de Vilanova (Site 626-035), Av. Alcalde Rovira Roure 80, Lleida, Leida, Spain|Hospital Del Mar (Site 626-025), Paseo Maritimo 25-29, Barcelona, Spain|Hospital Universitari Vall d'Hebron (Site 626-033), Passeig de la Vall d'Hebron 119-129, Barcelona, Spain|Hospital Clínic de Barcelona (Site 626-004), Carrer de Villaroel 170, Barcelona, Spain|Hospital Universitario de Bellvitge (Site 626-034), Carrer de la Feixa Llarga, s/n, Barcelona, Spain|Hospital General Universitario Gregorio Marañón (Site 626-001), Dr. Esquerdo, 46, Madrid, Spain|Hospital Clínico San Carlos (Site 626-017), Enfermedades infecciosas, C/Martin Lagos CN, Madrid, Spain|UCICEC (Clinical Trial Unit) Hospital Universitario La Paz (Site 626-012), Paseo de la Castellana 261, 2a planta Hospital Maternal, Madrid, Spain|University Hospital Zurich (Site 621-201), Department of Infectious Diseases and Hospital Epidemiology, Raemistrasse 100, Zürich, Zurich, Switzerland|MRC/UVRI and LSHTM Uganda Research Unit (Site 634-601), Entebbe Regional Referral Hospital, Entebbe, Uganda|Gulu Regional Referral Hospital (Site 634-603), Laroo Division, PO Box 160, Gulu, Uganda|Makerere University Lung Institute (Site 634-604), New Mulago Hospital Complex, Mulago Hill, Kampala, Uganda|St. Francis Hospital, Nsambya (Site 634-607), Nsambya Road Nsambya Hill, P.O. Box 7146, Kampala, Uganda|Lira Regional Referral Hospital (Site 634-605), Lira, Uganda|Masaka Regional Referral Hospital (Site 634-606), MRC/UVRI and LSHTM Uganda Research Unit, Plot 6 Circle Road, PO Box 556, Masaka, Uganda|Central City Clinical Hospital of Ivano-Frankivsk City Council (Site 627-302), Department of Therapy #1, Hetmana Mazepy str. 114, Ivano-Frankivs'k, Ukraine|Royal Victoria Infirmary (Site 634-007), Queen Victoria Road, Newcastle Upon Tyne, Northumbria, United Kingdom|Royal Free Hospital (Site 634-006), Pond Street, Hampstead, London, United Kingdom|Guy's and St. Thomas' NHS Foundation Trust (Site 634-011), London, United Kingdom
  • Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Triple (Participant, Care Provider, Investigator)|Primary Purpose: Treatment
  • Enrollment - 10000
  • Age - 18 Years and older   (Adult, Older Adult)
  • Outcome measures - Time from randomization to sustained recovery|All-cause mortality|Composite of time to sustained recovery and mortality|Days alive outside short-term acute care hospital|Pulmonary ordinal outcome|Pulmonary+ ordinal outcome|Incidence of clinical organ failure|Composite of death or serious clinical COVID-19 related events|Composite of cardiovascular events and thromboembolic events|Composite of grade 3 and 4 clinical adverse events, serious adverse events (SAEs) or death|Incidence of infusion reactions|Composite of SAEs or death|Change in SARS-CoV-2 neutralizing antibody levels|Change in overall titers of antibodies|Change in neutralizing antibody levels|Incidence of home use of supplemental oxygen above pre-morbid oxygen use|Incidence of no home use of supplemental oxygen above pre-morbid oxygen use
NCT04770467 A Safety and Efficacy Study of Human Monoclonal Antibodies, BRII-196 and BRII-198 for the Treatment of Patients With COVID-19 Withdrawn Phase 2 Feb/01/2021 Oct/01/2022
  • Alternative id - BRII-196-198-002
  • Interventions - Drug: BRII-196 and BRII-198|Drug: Placebo
  • Study type - Interventional
  • Study results - No Results Available
  • Locations - Investigative Site 1, Hong Kong, China
  • Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Single (Participant)|Primary Purpose: Treatment
  • Enrollment - 0
  • Age - 18 Years and older   (Adult, Older Adult)
  • Outcome measures - Incidence of adverse events (AEs)|Incidence of serious adverse events (SAEs)|Change from pre-dose baseline in RBC count|Change from pre-dose baseline in WBC count|Change from pre-dose baseline in Platelets count|Change from pre-dose baseline in Hemoglobin result|Change from pre-dose baseline in Creatine kinase result|Change from pre-dose baseline in Alanine aminotransferase (ALT) result|Time-weighted average changes in SARSCoV-2 RNA levels in nasopharyngeal swabs from baseline to Day 8|Duration of COVID-19 related symptoms through Day 29 among subjects with mild-moderate COVID-19|Proportion of subjects who have mild-moderate COVID-19 and develop severe COVID-19 after randomization|Assessment of PK parameters: maximum serum concentration observed (Cmax)
NCT04518410 ACTIV-2: A Study for Outpatients With COVID-19 Recruiting Phase 2|Phase 3 Aug/19/2020 Dec/31/2023
  • Alternative id - A5401/ACTIV-2|38742
  • Interventions - Biological: bamlanivimab|Drug: Placebo (IV)|Biological: BRII-196/BRII-198|Biological: AZD7442 (IV)|Biological: AZD7442 (IM)|Drug: SNG001|Drug: Camostat|Drug: Placebo (IM)|Drug: Placebo (Inhaled solution)|Drug: Placebo (oral tablet)|Biological: BMS-986414 + BMS-986413|Drug: Placebo (SC injections)|Biological: SAB-185 (3,840 Units/kg)|Biological: SAB-185 (10,240 Units/kg)|Drug: CASIRIVIMAB + IMDEVIMAB
  • Study type - Interventional
  • Study results - No Results Available
  • Locations - Pinnacle Research Group (Site 1082), 321 E. 10th Street, Anniston, Alabama, United States|North Alabama Research Center LLC (Site 1194), 721 W. Market St., Ste. B, Athens, Alabama, United States|University of Alabama at Birmingham (Site 1005), 908 20th Street South, Birmingham, Alabama, United States|Cullman Clinical Trials (Site 1140), 501 Clark St. NE., Cullman, Alabama, United States|Jasper Summit Research, LLC. (Site 1056), 1280 Summit, Jasper, Alabama, United States|Absolute Clinical Research, LLC. (Site 1186), 7725 North 43rd Avenue, Ste. 211, Phoenix, Arizona, United States|University of Arizona (Site 1043), 1501 N. Campbell Ave., Rm. 6410, Tucson, Arizona, United States|Omnibus Clinical Research (Site 1253), 3340 W. Ball Road, Ste. I, Anaheim, California, United States|Franco A. Felizarta MD (Site 1174), 3535 San Dimas St., Bakersfield, California, United States|Clearview Medical Research LLC. (Site 1251), 2714 Hidaway Ave., Ste. 103, Canyon Country, California, United States|St. Jude Heritage Medical Group (Site 1093), 2151 N. Harbor Blvd., Fullerton, California, United States|University of California San Diego (Site 1160), 9350 Campus Point Drive, Perlman Cancer Cancer, La Jolla, California, United States|Fadi A. Haddad, MD, Inc. (Site 1146), 8860 Center Dr., Ste. 320, La Mesa, California, United States|Atella Clinical Research (Site 1111), 5451 La Palma Avenue, La Palma, California, United States|Loma Linda University Health (Site 1110), 11374 Mountain View, Dover Bldg, Ste. C, Loma Linda, California, United States|University of Southern California (Site 1057), 1300 N. Mission Rd., Rm 349, Los Angeles, California, United States|UCLA CARE Center (Site 1003), 11075 Santa Monica Blvd., Suite 100, Los Angeles, California, United States|Science 37, Inc. (Site 1124), 12121 Bluff Creek Dr., Ste. 100, Los Angeles, California, United States|VA Northern California Health Care System (NAVREF) (Site 1137), 10535 Hospital Way, Mather, California, United States|Central Valley Research, LLC (Site 1085), 400 E. Orangeburg Ave., Ste. 5, Modesto, California, United States|Hoag Memorial Hospital Presbyterian (Site 1200), 1 Hoag Dr., Newport Beach, California, United States|Valley Clinical Research, Inc. (Site 1059), 18433 Roscoe Blvd., Ste 210, Northridge, California, United States|University of California Irvine (Site 1083), 843 Health Sciences Road, Orange, California, United States|FOMAT Medical Research (Site 1136), 300 South A Street, Oxnard, California, United States|Eisenhower Medical Center (Site 1040), 39000 Bob Hope Drive, Rancho Mirage, California, United States|Paradigm Research (Site 1150), 3652 Eureka Way, Redding, California, United States|Riverside Medical Clinic (Site 1232), 7117 Brockton Ave., Riverside, California, United States|University of California Davis Medical Center (Site 1097), 2315 Stockton Blvd., Sacramento, California, United States|Premier Urgent Care Centers of California, Inc. (Site 1176), 284 E. Highland Ave., San Bernardino, California, United States|University of California San Diego (Site 1002), 220 Dickinson Street, San Diego, California, United States|Zion Medical Center (Site 1063), 4647 Zion Avenue, San Diego, California, United States|VA San Diego Health System (Stie 1127), 3350 La Jolla, San Diego, California, United States|University of California San Francisco (Site 1009), 995 Potrero Ave., Building 80, Ward 84, San Francisco, California, United States|San Francisco Research Institute (Site 1210), 2435 Ocean Ave., San Francisco, California, United States|Stanford University (Site 1213), 1201 Welch Road, Stanford, California, United States|Millennium Clinical Trials (Site 1260), 550 Saint Charles Dr., Ste. 208, Thousand Oaks, California, United States|Office of Ramesh V. Nathan, MD (Site 1073), 2220 Lynn Rd., Ste. 301, Thousand Oaks, California, United States|Harbor UCLA (Site 1022), 1124 West Carson Street, Torrance, California, United States|Allianz Research Institute Inc. (Site 1159), 14120 Beach Blvd., Ste. 101, Westminster, California, United States|University of Colorado (Site 1007), 12401 East 17th Avenue, Aurora, Colorado, United States|UConn - Institute for Collaboration on Health (Site 1169), 2006 Hillside Rd., Unit 1248, Storrs, Connecticut, United States|Whitman-Walker Health (Site 1027), 1337 R Street NW., Washington, District of Columbia, United States|Imagine Research of Palm Beach County (Site 1157), 709 S. Federal Hwy., Ste. 2, Boynton Beach, Florida, United States|Bradenton Research Center Inc. (Site 1109), 3924 9th Ave. W, Bradenton, Florida, United States|Synergy Healthcare (Site 1099), 300 Riverside Drive E., Ste. 1350, Bradenton, Florida, United States|Cardiology Physicians, P.A. (Site 1180), 305 Memorial Medical Pkwy., Ste. 301, Daytona Beach, Florida, United States|Midland Florida Clinical Research Center LLC (Site 1130), 665 Peachwood Drive, DeLand, Florida, United States|Integrity Clinical Research (Site 1214), 3901 NW 79th Ave., Doral, Florida, United States|Universal Axon Clinical Research (Site 1077), 3650 NW 82nd Ave., Doral, Florida, United States|EMINAT Research (Site 1202), 2500 E. Commercial Blvd., Fort Lauderdale, Florida, United States|Holy Cross Health (Site 1072), 4725 North Federal Highway, Fort Lauderdale, Florida, United States|North Florida / South Georgia Veterans Health System (Site 1133), 1601 SW Archer Rd., Gainesville, Florida, United States|University of Florida (Site 1047), 1600 SW. Archer Rd., Gainesville, Florida, United States|NW FL Clinical Research Group, LLC. (Site 1046), 400 Gulf Breeze Parkway, Gulf Breeze, Florida, United States|Indago Research and Health Center (Site 1050), 3700 W. 12th Ave., Ste. 300, Hialeah, Florida, United States|AGA Clinical Trials (Site 1026), 900 West 49th Street, Hialeah, Florida, United States|Community Research of South Florida (Site 1197), 7100 W. 20th Ave., Ste. 403, Hialeah, Florida, United States|New Generation Medical Research (Site 1204), 7600 W. 20th Ave., Ste. 106, Hialeah, Florida, United States|Best Quality Research, Inc. (Site 1237), 2387 W. 68th St., Ste. 403, Hialeah, Florida, United States|Innovative Health Medical Center (Site 1222), 6750 Taft Street, Hollywood, Florida, United States|University of Florida Jacksonville (Site 1039), 655 West 8th Street, Jacksonville, Florida, United States|Mayo Clinic Jacksonville (Site 1149), 4500 San Pablo Rd. S., Jacksonville, Florida, United States|QC Trials (Site 1117), 300 W. 41st Street, Ste. 203, Miami Beach, Florida, United States|Lakes Research (Site 1037), 5801 NW 151 Street, Miami Lakes, Florida, United States|Savin Medical Group, LLC. (Site 1212), 5789B NW. 151st Street, Miami Lakes, Florida, United States|Amber Clinical Research, LLC. (Site 1206), 9000 NE. 2nd Avenue, Miami Shores, Florida, United States|Gonzalez MD & Aswad MD Health Services (Site 1238), 3401 NW. 7th Street, Miami, Florida, United States|Clintex Research Group, Inc. (Site 1231), 590 SW. 27th Ave., Miami, Florida, United States|Advance Medical Research Center (Site 1193) 330 SW. 27th Ave., Ste. 701, Miami, Florida, United States|University of Miami Miller School of Medicine CoVID Unit (Site 1068), 1425 NW. 10th Ave., Miami, Florida, United States|Florida International Medical Research (Site 1239), 1890 S. Red Rd., Ste. 103, Miami, Florida, United States|D&H National Research Centers (Site 1205), 8485 Bird Road, Miami, Florida, United States|Allied Biomedical Research Institute (Site 1227), 7100 SW. 47th St., Ste. 220, Miami, Florida, United States|Miami Clinical Research (Site 1089), 2400 SW. 69th Ave., Miami, Florida, United States|Research Institute of South Florida, Inc. (Site 1201), 9835 SW. 72nd Street, Ste. 201, Miami, Florida, United States|RM Medical Research, Inc. (Site 1230), 10346 W. Flagler St., Miami, Florida, United States|Pro Live Medical Research Corp (Site 1219), 12781 SW. 42nd Street, Miami, Florida, United States|Miami Dade Medical Research Institute, LLC (Site 1223), 8955 SW. 87th Ct., Miami, Florida, United States|Bravo Health Care Center (Site 1221), 1440 79 Street, North Bay Village, Florida, United States|Orlando Immunology Center (Site 1045), 1707 North Mills Avenue, Orlando, Florida, United States|Clintheory (Site 1203), 7350 Sandlake Commons Blvd., Orlando, Florida, United States|IMIC, Inc. (Site 1141), 18320 Franjo Rd, Palmetto Bay, Florida, United States|Family Clinical Trials (Site 1236), 1601 N. Palm Ave., Ste. 102, Pembroke Pines, Florida, United States|Physician Care Clinical Research, LLC. (Site 1242), 1617 S. Tuttle Ave., Ste. 1A, Sarasota, Florida, United States|Bassetti Medical Research, Inc. (Site 1158), 5825 US Highway 27 N., Sebring, Florida, United States|DBC Research (Site 1188), 7707 N. University Dr., Ste. 106, Tamarac, Florida, United States|ETNA Medical Center (Site 1225), 7401 N. University Drive, Tamarac, Florida, United States|Moore Clinical Research, Inc. (Site 1164), 4257 W. Kennedy Blvd., Tampa, Florida, United States|Tampa General Hospital Family Care Center Healthpark (Site 1088), 5802 N. 30th Street, Tampa, Florida, United States|Infectious Disease Consultants of the Treasure Coast (Site 1171), 3735 11th Cir., Ste. 201, Vero Beach, Florida, United States|AIDS Research and Treatment Center of the Treasure Coast (Site 1095), 981 37th Place, Vero Beach, Florida, United States|Triple O Research Institute PA (Site 1121), 2580 Metrocentre Blvd., Ste. 4, West Palm Beach, Florida, United States|The Ponce de Leon Center (site 1015), 341 Ponce De Leon Avenue Northeast, Atlanta, Georgia, United States|Rare Disease Research, LLC. (Site 1248), 1891 Howell Mill Rd.NW, Ste. B, Atlanta, Georgia, United States|Agile Clinical Rsearch Trials, LLC (Site 1051), 750 Hammond Drive, Atlanta, Georgia, United States|Balanced Life Health Care Solutions/SKYCRNG (Site 1191), 2033 Buford Hwy., Ste. 109, Buford, Georgia, United States|IACT Health (Site 1035), 800 Talbotton Road, Columbus, Georgia, United States|Clintheory (Site 1254), 4300 Pleasant Hill Road, Duluth, Georgia, United States|One Health Research Clinic, Inc. (Site 1250), 5880 Live Oak Pkwy, Ste. 160, Norcross, Georgia, United States|Renew Health Clinical Research, LLC. (Site 1161), 1550 Janmar Rd., Snellville, Georgia, United States|John A. Burns School of Medicine UH Clinics at Kakaako (Site 1177), 651 Ilalo St., Honolulu, Hawaii, United States|Snake River Research, PLLC (Site 1120), 2900 Cortez Ave., Idaho Falls, Idaho, United States|Metro Infectious Disease Consultants (Site 1106), 901 McClintock Dr., Ste. 201, Burr Ridge, Illinois, United States|Chicago Clinical Research Institute (Site 1132), 611 W. Roosevelt Rd., Chicago, Illinois, United States|Northwestern University (Site 1025), 645 North Michigan Ave, Chicago, Illinois, United States|Rush University Medical Center (Site 1017), 600 Paulina St., Chicago, Illinois, United States|University of Illinois at Chicago (Site 1147), 835 South Wood Street, Chicago, Illinois, United States|University of Chicago (Site 1064), 5841 S. Maryland Ave., Chicago, Illinois, United States|Great Lakes Clinical Trials (Site 1049), 5149 N. Ashland Ave., Chicago, Illinois, United States|Investigators Research Group, LLC. (Site 1170), 321 E. Northfield Dr., Ste. 100, Brownsburg, Indiana, United States|Roudebush VA Medical Center (Site 1217), 550 University Blvd, Indianapolis, Indiana, United States|University of Kansas Medical Center (Site 1042), 3901 Rainbow Boulevard, Kansas City, Kansas, United States|MedPharmics (Site 1065), 3800 Houma Blvd., Metairie, Louisiana, United States|Clinical Trials of America, LLC. (Site 1245) 3201 Armand Street, Monroe, Louisiana, United States|New Orleans Adolescent Trials Unit (Site 1028), 1440 Canal St., Suite 904, New Orleans, Louisiana, United States|Louisiana State University Health Sciences Center (Site 1153), 2000 Canal Street, New Orleans, Louisiana, United States|Ochsner Clinic Foundation (Site 1218), 1514 Jefferson Highway, New Orleans, Louisiana, United States|Baltimore VA Medical Center (Site 1258), 10 N. Greene St., Baltimore, Maryland, United States|Johns Hopkins University (Site 1006), 1830 East Monument Street, Baltimore, Maryland, United States|Walter Reed Army Institute of Research (Site 1118), 503 Robert Grant Ave., Silver Spring, Maryland, United States|Massachusetts General Hospital (Site 1016), 55 Fruit Street, Boston, Massachusetts, United States|Beth Israel Deaconess Medical Center (Site 1166), 110 Francis Street, Boston, Massachusetts, United States|Brigham and Women's Hospital - Therapeutics Clinical Research Site (Site 1023), 75 Francis Street, Boston, Massachusetts, United States|University of Massachusetts Medical School (Site 1054), 55 Lake Avenue N., Worcester, Massachusetts, United States|Vida Clinical Studies (Site 1244), 3815 Pelham Street, Dearborn, Michigan, United States|Revive Research Institute (Site 1257), 32255 Northwestern Hwy., Farmington Hills, Michigan, United States|Revival Research Corporation (Site 1256), 13409 East 14 Mile Road, Sterling Heights, Michigan, United States|Memorial Hospital at Gulfport (Site 1104), 4500 13th Street, Gulfport, Mississippi, United States|MedPharmics, LLC. (Site 1032), 15190 Community Rd., Gulfport, Mississippi, United States|University of Missouri Health Care System (Site 1224), 1 Hospital Drive, Columbia, Missouri, United States|Hannibal Clinic (Site 1129), 100 Medical Drive, Hannibal, Missouri, United States|Washington University School of Medicine (Site 1008), 620 South Taylor, Suite 200, Saint Louis, Missouri, United States|Bozeman Health Deaconess Hospital (Site 1115), 931 Highland Blvd, Ste. 3103, Bozeman, Montana, United States|Mercury Street Medical Group (Site 1074), 300 W. Mercury St., Butte, Montana, United States|Quality Clinical Research (Site 1112), 10040 Regency Circle, Omaha, Nebraska, United States|Las Vegas Medical Research (Site 1048), 8530 W. Sunset Rd., Las Vegas, Nevada, United States|AXCES Research Group (Site 1152), 531 Harkle Road, Santa Fe, New Mexico, United States|Bronx Prevention Research Center (Site 1108), 390 East 158th Street, Bronx, New York, United States|Lincoln Hospital (Site 1092), 249 East 149th Street, Bronx, New York, United States|Urban Health Plan, Inc. (Site 1243), 1065 Southern Blvd, Bronx, New York, United States|Jacobi Medical Center (Site 1105), 1400 Pelham Parkway South, Bronx, New York, United States|James J. Peters VA Medical Center (Site 1053), 130 West Kingsbridge Road, Bronx, New York, United States|Maimonides Medical Center (Site 1138), 4802 10th Avenue, Brooklyn, New York, United States|University at Buffalo, Emergency Medicine (Site 1172), 77 Goodell Street, Buffalo, New York, United States|Flushing Hospital Medical Center (Site 1067), 4500 Parsons Blvd, Flushing, New York, United States|Jamaica Hospital Medical Center (Site 1066), 8900 Van Wyck Expressway, Jamaica, New York, United States|Columbia Partnership for Prevention and Control of HIV/AIDS CTU (Site 1019), Columbia University Irving Medical Center, Department of Medicine - Division of Infectious Diseases, 180 Fort Washington Avenue, HP6 - Rm 604, New York, New York, United States|Cornell Clinical Trials Unit (Site 1011), NewYork-Presbyterian Hospital-Weill Cornell Medical Center, 525 East 68th Street, New York, New York, United States|Canton-Potsdam Hospital (Site 1076), 50 Leroy Street, Potsdam, New York, United States|University of Rochester (Site 1010), 601 Elmwood Ave, Rochester, New York, United States|SUNY Stony Brook NICHD (Site 1094), HSC L-02, Rm. 142 C, Stony Brook, New York, United States|University of North Carolina at Chapel Hill (Site 1001), 130 Mason Farm Rd., Bioinformatics Bldg, 2nd Floor, Chapel Hill, North Carolina, United States|Carolina Clinical Research (Site 1167), 9040 Nations Ford Rd., Charlotte, North Carolina, United States|Research Carolina Elite (Site 1247), 7480 Waterside Loop Road, Suite 201, Denver, North Carolina, United States|Duke University Medical Center (Site 1041), 40 Duke Medicine Circle, Durham, North Carolina, United States|Carteret Medical Group, LLC. (Site 1249), 302 Medical Park Ct., Morehead City, North Carolina, United States|Wake Forest University Health Sciences (Site 1038), 1 Medical Center Boulevard, Winston-Salem, North Carolina, United States|Sanford Health (Site 1084), 801 Broadway N., Fargo, North Dakota, United States|The Christ Hospital (Site 1119), 2123 Auburn Avenue, Cincinnati, Ohio, United States|Case Western Reserve University (Site 1033), 2061 Cornell Road, Cleveland, Ohio, United States|MetroHealth Medical Center (Site 1195), 2500 Metrohealth Dr., Cleveland, Ohio, United States|Ohio State University Medical Center (Site 1020), 480 Medical Center Drive, Columbus, Ohio, United States|Cincinnati CRS (Site 1004), University of Cincinnati, University Hospital, 200 Albert Sabin Way, Ohio City, Ohio, United States|STAT Research (Site 1107), 66 Remick Blvd., Springboro, Ohio, United States|Ascension St. John Clinical Research Institute (Site 1090), 1725 East 19th Street, Tulsa, Oklahoma, United States|Providence Portland Medical Center (Site 1098), 4805 NE. Glisan Street, Portland, Oregon, United States|Kaiser Permanente Center for Health Research (Site 1079), 3800 N. Interstate Ave., Portland, Oregon, United States|Portland VA Medical Center (Site 1131), 3710 SW US Veterans Hospital Rd., Portland, Oregon, United States|Oregon Health and Science University (Site 1259), 3181 SW. 10th Avenue, Portland, Oregon, United States|Doylestown Hospital (Site 1122), 595 W. State Street, Doylestown, Pennsylvania, United States|University of Pennsylvania (Site 1031), 3400 Spruce Street, Philadelphia, Pennsylvania, United States|The University of Pittsburgh (Site 1018), 3471 5th Ave., Pittsburgh, Pennsylvania, United States|Veterans Affairs Pittsburgh Healthcare System (Site 1070), University Drive C., Pittsburgh, Pennsylvania, United States|The Miriam Hospital Clinical Research Site (1142), 164 Summit Avenue, Providence, Rhode Island, United States|Medtrial, LLC (Site 1134), 1718 Saint Julian Pl., Ste. 2, Columbia, South Carolina, United States|Clinovacare Medical Clinical Research Center (Site 1211), 160 Medical Circle Suite D, West Columbia, South Carolina, United States|American Indian Clinical Trials Research Network (Site 1148), 717 Meade Street, Rapid City, South Dakota, United States|Sanford USD Medical Center (Site 1078), 1305 W. 18th St., Sioux Falls, South Dakota, United States|Clinical Trials Center of Middle Tennessee (Site 1183), 100 Covey Drive, Franklin, Tennessee, United States|Vanderbilt Therapeutics Clinical Research (Site 1013), Vanderbilt Health One Hundred Oaks, 719 Thompson Ln., Ste 47183, Nashville, Tennessee, United States|Saint Hope Foundation Inc. (Site 1100), 6800 West Loop Street, Ste. 560, Bellaire, Texas, United States|South Texas Medical Research Institute, Inc./TTS Research (Site 1198), 1420 River Road, Boerne, Texas, United States|PanAmerican Clinical Research, LLC. (Site 1069), 1416 Palm Blvd., Brownsville, Texas, United States|Trinity Health and Wellness Center (Site 1030), 219 Sunset Avenue, Dallas, Texas, United States|UT Southwestern HIV/ID Clinical Trials Unit (Site 1208), 1936 Amelia Court, Dallas, Texas, United States|Doctors Hospital at Renaissance Health Institute for Research and Development (Site 1145), 5323 S. McColl Rd., Edinburg, Texas, United States|Sealy Institute for Vaccine Sciences Clincial Trials Program (Site 1044), 400 Harborside Drive, Galveston, Texas, United States|Rheumatology Center of Houston (Site 1252), 1200 Binz St., Ste. 1495, Houston, Texas, United States|Lyndon B. Johnson Hospital (Site 1014), 5656 Kelley Street, Houston, Texas, United States|University of Texas Health Science Center at Houston (Site 1055), 6431 Fannin Street, Ste. 2.112, Houston, Texas, United States|Houston Methodist Hospital (Site 1123), 6565 Fannin Street, Houston, Texas, United States|Dynamic Medical Research Group (Site 1081), 8314 Southwest Fwy, Houston, Texas, United States|Fairway Medical Clinic (Site 1156), 4910 Telephone Road, Houston, Texas, United States|Houston Heart and Vascular Associates (Site 1215), 1485 FM 1960 Bypass R. E., Ste. 100, Humble, Texas, United States|SMS Clincial Research, LLC. (Site 1060), 1210 N. Galloway Ave., Mesquite, Texas, United States|Epic Medical Research, LLC (Site 1233), 106 Plaza Drive, Red Oak, Texas, United States|San Antonio Military Medical Center (Site 1173), 3551 Roger Brooke Dr., San Antonio, Texas, United States|Inova Fairfax Medical Campus (Site 1029), 3300 Gallows Road, Falls Church, Virginia, United States|Clinical Research Partners LLC (Site 1196), 7110 Forest Ave., Ste. 201, Richmond, Virginia, United States|EvergreenHealth (Site 1080), 12040 NE 128th Street, Ste MS-77, Kirkland, Washington, United States|University of Washington ACTU (Site 1012), Harborview Medical Center, 325 9th Ave., Seattle, Washington, United States|Providence Medical Research Center (Site 1075), 105 W. 8th Ave., Ste. 6050W, Spokane, Washington, United States|Hershel Woody Williams VA Medical Center (Site 1128), 1540 Spring Valley Drive, Huntington, West Virginia, United States|West VA University, Mary Babb Randolph Cancer Center (Site 1178), 1 Medical Center Drive, Morgantown, West Virginia, United States|Vida Clinical Studies (Site 1246), 5757 West Oklahoma Avenue, Milwaukee, Wisconsin, United States|Medical College of Wisconsin, Inc. (Site 1036), 8701 Watertown Plank Road, Milwaukee, Wisconsin, United States|Allegiance Research Specialists (Site 1162), 2645 N. Mayfair Rd., Ste. 200, Wauwatosa, Wisconsin, United States|Instituto Médico Platense (Site 3011), Avenida 51 335, La Plata, Buenos Aires, Argentina|Fundación Sanatorio Güemes (Site 3001), Francisco Acuña de Figueroa 1240, Buenos Aires, Ciudad Autónoma De Buenos Aires, Argentina|Instituto Médico Río Cuarto (Site 3005), Hipólito Yrigoyen 1020, Río Cuarto, Córdoba, Argentina|Instituto Médico de la Fundación Estudios Clínicos (Site 3009), Italia 428, Rosario, Santa Fe, Argentina|Clínica Adventista Belgrano (Site 3007), Estomba 1710, Ciudad Autonoma de Buenos Aires, Argentina|Instituto Ave Pulmo (Site 3006), Carlos M. Alvear 3345, Mar Del Plata, Argentina|Hospital Universitario Austral (Site 3004), Av. Juan Domingo Peron, Derqui, Pilar, Argentina|L2 Ip - Instituto de Pesquisas Clinicas Ltda (Site 4008), SGAS 613, Conjunto E, Lote 95, Sala 6, Brasília, Distrito Federal, Brazil|Hospital Das Clinicas Da Universidade Federal de Minas Gerais (Site 4001), Avenida Alfredo Balena 190, Belo Horizonte, Minas Gerais, Brazil|SOM Federal University Minas Gerais Brazil (Site 4002), Avenida Alfredo Balena 190, Belo Horizonte, Minas Gerais, Brazil|Hospital Nossa Senhora da Conceicao (Site 4004), Avenida Francisco Trein 596, Porto Alegre, Rio Grande Do Sul, Brazil|Hospital Dia do Pulmão (Site 4007), Rua Engenheiro Paul Werner, 1141, Blumenau, Santa Catarina, Brazil|Hospital Das Clinicas da Faculdade de Medicina de Ribeirão Preto (Site 4003), Avenida Bandeirantes 3900, Campus Universitário, Ribeirão Preto, São Paulo, Brazil|Instituto de Pesquisa Clínica Evandro Chagas (Site 4005), Avenida Brasil, 4365, Rio De Janeiro, Brazil|Hospital E Maternidade Celso Pierro (Site 4006), Avenue John Boyd Dunlop S/n, São Paulo, Brazil|Medical Arts Health Research Group (Site 2003), 360-1855 Kirschner Rd., Kelowna, British Columbia, Canada|Vancouver ID Research and Care Centre Society (Site 2006), Infectious Disease Clinic Downtown, Vancouver, British Columbia, Canada|Dr. Anil K. Gupta Medicine Professional Corporation (Site 2004), 1620 Albion Rd., Suite 106, Toronto, Ontario, Canada|Clinica San Agustin Research (Site 9601), Meters West from the National Bank, Desamparados, San José, Costa Rica|Corporacion GIHEMA SA (Site 9602), Carretera Prospero Fernandez, Escazú, Costa Rica|Centro Medico Militar (Site 9401), Finca El Palomar, Acatan, Sta. Rosita Zona 16, Ciudad De Guatemala, Guatemala|CIMAB SA de CV (Site 6002), Francisco I Madero 270 Sur, Torreon, Coahuila, Mexico|Oaxaca Site Management Organization (Site 6004), Calle Humboldt 302, Colonia Centro, Oaxaca, Distrito Federal, Mexico|Instituto Jalisciense de Investigacion Clinica SA de CV (Site 6005), Penitenciaria Numero 20, Colonia Centro, Guadalajara, Jalisco, Mexico|Centro de Investigación Farmacéutica Especializada de Occidente (Site 6006), Av. Vallarta 1670, Piso 2 PH1, Colonia Americana, Guadalajara, Jalisco, Mexico|Neurociencias Estudios Clinicos S.C. (Site 6008), Boulevard Alfonso G. Calderon, 2193 int 2 A desarrollo urbano 3 rios, Culiacán, Sinaloa, Mexico|Hospital Civil De Culiacan (Site 6011), Avenida Álvaro Obregón 1422, Culiacán, Sinaloa, Mexico|Eme Red Hospitalaria (Site 6010), Calle 33 No. 496, Mérida, Yucatán, Mexico|Kohler and Milstein Research (Site 6013), Avenida Colón 197, García Ginerés, Mérida, Yucatán, Mexico|De La Salle Health Sciences Institute (Site 9504), Gov. Mangubat Avenue, Cavite City, Cavite, Philippines|Makati Medical Center (Site 9502), No. 2 Amorsolo Street, Legaspi Village, Makati City, National Capital Region, Philippines|Asian Hospital and Medical Center (Site 9503), 2205 Civic Drive, Muntinlupa, National Capital Region, Philippines|Puerto Rico AIDS Clinical Trials Unit (Site 1024), Proyecto ACTU Biomedical Building II, San Juan, Puerto Rico|Peermed Clinical Trial Center (Site 9215), Corner of Voortrekker and Monument Roads, Kempton Park, Ekurhuleni, Gauteng, South Africa|Worthwhile Clinical Trials (Site 9214), No. 1 Mowbray Avenue, Benoni, Gauteng, South Africa|The Aurum Institute Tembisa Clinical Research Site (Site 9217), Cnr Flint Mazibuko / Rev RTJ Namane Drive, Johannesburg, Gauteng, South Africa|Roodepoort Medicross (Site 9220), 54 Ontdekkers Road, Johannesburg, Gauteng, South Africa|Soweto ACTG CRS (Site 9203), Chris Hani Road, Johannesburg, Gauteng, South Africa|Helen Joseph Hospital (Site 9201), Perth Road, Johannesburg, Gauteng, South Africa|Setshaba Research Centre (Site 9205), 2088 Block H, Pretoria, Gauteng, South Africa|Into Research (Site 9210), Totius Street, Tshwane, Gauteng, South Africa|Durban International Clinical Research Site (Site 9208), Sidmouth Avenue, Durban, Kwazulu - Natal, South Africa|Welkom Clinical Trial Centre (Site 9211), 189 Power Road, Welkom, Matjhabeng, Free State, South Africa|The Aurum Institute Klerksdorp Clinical Research Center (Site 9204), Corner Margaretha Prinsloo St. and O.R. Tambo St., Klerksdorp, North-West, South Africa|The Aurum Institute Rustenburg Clinical Research Site (Site 9202), 50 Steen St., c/o Pretorius St., Rustenburg, North-West, South Africa|TASK Eden (Site 9218), G, 4 Victoria St., George, South Africa|CLINRESCO, ARWYP Medical Suites (Site 9209), 22 Pine Avenue, Johannesburg, South Africa|Mzansi Ethical Research Centre (Site 9212), 184 Cowen Ntuli Street, Steve Tschwete, Mpumalanga, South Africa|Global Clinical Trials Sunnyside (Site 9216), 175 Steve Biko Street, Pretoria, South Africa
  • Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Triple (Participant, Care Provider, Investigator)|Primary Purpose: Treatment
  • Enrollment - 8797
  • Age - 18 Years and older   (Adult, Older Adult)
  • Outcome measures - COVID-19 symptom duration (Phase 2)|Quantification of SARS-CoV-2 RNA (Phase 2)|Proportion of participants with new adverse event (AE) ≥ Grade 3 (Phase 2)|Cumulative incidence of death due to any cause or hospitalization due to any cause (Phase 3)|Proportion of participants with new adverse event (AE) ≥ Grade 3 (Phase 3)|COVID-19 symptom duration (Phase 3)|Quantification of SARS-CoV-2 RNA (Phase 3)|Cumulative incidence of death from any cause or hospitalization due to any cause (Phase 2)|Cumulative incidence of death from any cause, or hospitalization due to any cause related to COVID-19 (Phase 3)|Level of SARS-CoV-2 RNA from NP swabs (Phase 2)|Level of SARS-CoV-2 RNA from NP swabs (Phase 3)|Duration of targeted clinical COVID-19 symptoms (Phases 2 and 3)|COVID-19 symptom severity ranking (Phases 2 and 3)|Proportion of participants with ≥1 worsening symptom of COVID-19 (Phases 2 and 3)|Time to self-reported return to usual health (a) (Phases 2 and 3)|Cumulative incidence of death due to any cause or hospitalization due to any cause (Phases 2 and 3)|Oxygen saturation level (Phases 2 and 3)|AUC of SARS-CoV-2 RNA from site-collected NP swabs (Phase 2)|Incidence of new adverse event (AE) ≥ Grade 2 (Phases 2 and 3)|Incidence of new adverse event (AE) ≥ Grade 3 (Phases 2 and 3)|Time to self-reported return to usual health (b) (Phases 2 and 3)
NCT04479644 Safety, Tolerability, and Pharmacokinetics Study of Human Monoclonal Antibody BRII-198 Completed Phase 1 Jul/13/2020 Feb/03/2021
  • Alternative id - BRII-198-001
  • Interventions - Drug: BRII-198|Drug: Placebo
  • Study type - Interventional
  • Study results - No Results Available
  • Locations - Investigative Site, Beijing, Beijing, China
  • Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Single (Participant)|Primary Purpose: Treatment
  • Enrollment - 17
  • Age - 18 Years to 49 Years   (Adult)
  • Outcome measures - Incidence of adverse events (AEs) by CTCAE v5.0|Proportion of subjects with SAEs|Proportion of subjects with infusion-related reactions|Proportion of subjects with hypersensitivity reactions|Serum Concentration of BRII-198
NCT04787211 A Study of Human Monoclonal Antibodies, BRII-196 and BRII-198 Completed Phase 2 Jun/20/2021 Dec/02/2021
  • Alternative id - BRII-196-198-004
  • Interventions - Drug: BRII-196 and BRII-198|Drug: Placebo
  • Study type - Interventional
  • Study results - No Results Available
  • Locations - Beijing Ditan Hospital Capital Medical University, Beijing, Beijing, China|Guangzhou Eighth Hospital, Guangzhou Medical University, Guangzhou, Guangdong, China|The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong, China|The Third People's Hospital of Shenzhen, Shenzhen, Guangdong, China|Subei People's Hospital of Jiangsu province, Yangzhou, Jiangsu, China|Yunnan Provincial Infectious Disease Hospital, Kunming, Yunnan, China
  • Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Single (Participant)|Primary Purpose: Treatment
  • Enrollment - 48
  • Age - 18 Years and older   (Adult, Older Adult)
  • Outcome measures - Incidence of adverse events (AEs)|Incidence of serious adverse events (SAEs)|Change from pre-dose baseline in RBC count|Change from pre-dose baseline in WBC count|Change from pre-dose baseline in Platelets count|Change from pre-dose baseline in Hemoglobin result|Change from pre-dose baseline in Creatine kinase result|Change from pre-dose baseline in Alanine aminotransferase (ALT) result|Time-weighted average changes in SARSCoV-2 RNA levels in nasopharyngeal swabs from baseline to Day 8|Duration of COVID-19 related symptoms through Day 29 among subjects with mild-moderate COVID-19|Proportion of subjects who have mild-moderate COVID-19 and develop severe COVID-19 after randomization|Assessment of PK parameters (Group A and B): maximum serum concentration observed (Cmax)
NCT04691180 A Phase 1 Study of Human Monoclonal Antibodies, BRII-196 and BRII-198 Completed Phase 1 Jan/05/2021 Sep/16/2021
  • Alternative id - BRII-196-198-001
  • Interventions - Drug: BRII-196 and BRII-198|Drug: Placebo
  • Study type - Interventional
  • Study results - No Results Available
  • Locations - Investigative Site, Beijing, Beijing, China
  • Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Single (Participant)|Primary Purpose: Treatment
  • Enrollment - 12
  • Age - 18 Years to 49 Years   (Adult)
  • Outcome measures - Incidence of adverse events (AEs) by CTCAE v5.0|Proportion of subjects with SAEs|Proportion of subjects with infusion-related reactions|Proportion of subjects with hypersensitivity reactions|Mean of change from pre-dose baseline in ECG readings|Mean of change from pre-dose baseline in WBC count.|Mean of change from pre-dose baseline in RBC count|Mean of change from pre-dose baseline in Platelets count|Mean of change from pre-dose baseline in Hemoglobin result|Serum Concentration of BRII-196 and BRII-198