ACTIV-2: A Study for Outpatients With COVID-19

August 1, 2024 updated by: National Institute of Allergy and Infectious Diseases (NIAID)

Adaptive Platform Treatment Trial for Outpatients With COVID-19 (Adapt Out COVID)

Drug studies often look at the effect one or two drugs have on a medical condition, and involve one company. There is currently an urgent need for one study to efficiently test multiple drugs from more than one company, in people who have tested positive for COVID-19 but who do not currently need hospitalization. This could help prevent disease progression to more serious symptoms and complications, and spread of COVID-19 in the community.

This study looks at the safety and effectiveness of different drugs in treating COVID-19 in outpatients. In Phase II, participants in the study will be treated with either a study drug or with placebo. In protocol version 7.0, participants in Phase III of the study will be treated with either a study drug or active comparator drug. Participants assigned to the bamlanivimab agent/placebo arm and will have 28 days of intensive follow-up following study drug administration, followed by limited follow-up through 24 weeks in phase II and in phase III. All other investigational agents and their corresponding placebo arms will involve 28 days of intensive follow-up, followed by limited follow-up through 72 weeks in phase II and phase III. Additional study visits may be required, depending on the agent.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a master protocol to evaluate the safety and efficacy of multiple investigational agents aimed at modifying the host immune response to SARS-CoV-2 infection, or directly enhancing viral control in order to limit disease progression.

The study includes both infused and non-infused agents and is a randomized controlled platform that allows agents to be added and dropped during the course of the study for efficient phase II and phase III testing of new agents within the same trial infrastructure.

Version 7 of the protocol provided for blinded phase II evaluation of an investigational agent for superiority to placebo among participants at lower risk of progression to hospitalization or death, regardless of the mode of administration of the agent.

Agents that graduate to phase III after initiation of the protocol version will be evaluated in persons at higher risk for progression to hospitalization or death for non-inferiority to an active comparator (monoclonal antibody cocktail of casirivimab plus imdevimab (REGEN-COV, Regeneron). This active comparator has been shown to be effective in this population in preventing hospitalization or death. When two or more agents are being evaluated in the same phase of the study, the trial design includes sharing of the control group (placebo in phase II and active comparator in phase III) for efficient evaluation of each agent.

Investigational agents will be approved by the Trial Oversight Committee (TOC) for phase II evaluation based on the presence of in vitro data demonstrating promise as anti-SARS-CoV-2 therapeutics in pre-clinical testing, and for which there are suitable pharmacokinetics and safety data from phase I testing, or through clinical or research testing for a different indication, and agent availability. Investigational agents will be included in phase III evaluation based on agent entry criteria for phase III as outlined in the protocol (or by TOC approval based on data available outside ACTIV-2).

Study Type

Interventional

Enrollment (Actual)

4044

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Ciudad Autonoma de Buenos Aires, Argentina, C1430EGF
        • Clínica Adventista Belgrano (Site 3007), Estomba 1710
      • Mar Del Plata, Argentina, B7602DCK
        • Instituto Ave Pulmo (Site 3006), Carlos M. Alvear 3345
      • Pilar, Argentina, B1629ODT
        • Hospital Universitario Austral (Site 3004), Av. Juan Domingo Peron, Derqui
    • Buenos Aires
      • La Plata, Buenos Aires, Argentina, B1900AVG
        • Instituto Médico Platense (Site 3011), Avenida 51 335
    • Ciudad Autónoma De Buenos Aires
      • Buenos Aires, Ciudad Autónoma De Buenos Aires, Argentina, C1180AAX
        • Fundación Sanatorio Güemes (Site 3001), Francisco Acuña de Figueroa 1240
    • Córdoba
      • Río Cuarto, Córdoba, Argentina, 5800
        • Instituto Médico Río Cuarto (Site 3005), Hipólito Yrigoyen 1020
    • Santa Fe
      • Rosario, Santa Fe, Argentina, S2013DTC
        • Instituto Médico de la Fundación Estudios Clínicos (Site 3009), Italia 428
  • Brazil
      • Rio De Janeiro, Brazil, 21040-360
        • Instituto de Pesquisa Clínica Evandro Chagas (Site 4005), Avenida Brasil, 4365
      • São Paulo, Brazil, 13059-900
        • Hospital E Maternidade Celso Pierro (Site 4006), Avenue John Boyd Dunlop S/n
    • Distrito Federal
      • Brasília, Distrito Federal, Brazil, 70200-730
        • L2 Ip - Instituto de Pesquisas Clinicas Ltda (Site 4008), SGAS 613, Conjunto E, Lote 95, Sala 6
    • Minas Gerais
      • Belo Horizonte, Minas Gerais, Brazil, 30130-100
        • Hospital Das Clinicas Da Universidade Federal de Minas Gerais (Site 4001), Avenida Alfredo Balena 190
      • Belo Horizonte, Minas Gerais, Brazil, 30130-100
        • SOM Federal University Minas Gerais Brazil (Site 4002), Avenida Alfredo Balena 190
    • Rio Grande Do Sul
      • Porto Alegre, Rio Grande Do Sul, Brazil, 91850-200
        • Hospital Nossa Senhora da Conceicao (Site 4004), Avenida Francisco Trein 596
    • Santa Catarina
      • Blumenau, Santa Catarina, Brazil, 89030-101
        • Hospital Dia do Pulmão (Site 4007), Rua Engenheiro Paul Werner, 1141
    • São Paulo
      • Ribeirão Preto, São Paulo, Brazil, 14048-900
        • Hospital Das Clinicas da Faculdade de Medicina de Ribeirão Preto (Site 4003), Avenida Bandeirantes 3900, Campus Universitário
  • Canada
    • British Columbia
      • Kelowna, British Columbia, Canada, V1Y 4N7
        • Medical Arts Health Research Group (Site 2003), 360-1855 Kirschner Rd.
  • Guatemala
      • Ciudad De Guatemala, Guatemala, 01011
        • Centro Medico Militar (Site 9401), Finca El Palomar, Acatan, Sta. Rosita Zona 16
  • Mexico
    • Coahuila
      • Torreon, Coahuila, Mexico, 27000
        • CIMAB SA de CV (Site 6002), Francisco I Madero 270 Sur
    • Distrito Federal
      • Oaxaca, Distrito Federal, Mexico, 68000
        • Oaxaca Site Management Organization (Site 6004), Calle Humboldt 302, Colonia Centro
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44100
        • Instituto Jalisciense de Investigacion Clinica SA de CV (Site 6005), Penitenciaria Numero 20, Colonia Centro
      • Guadalajara, Jalisco, Mexico, 44160
        • Centro de Investigación Farmacéutica Especializada de Occidente (Site 6006), Av. Vallarta 1670, Piso 2 PH1, Colonia Americana
    • Sinaloa
      • Culiacán, Sinaloa, Mexico, 80020
        • Neurociencias Estudios Clinicos S.C. (Site 6008), Boulevard Alfonso G. Calderon, 2193 int 2 A desarrollo urbano 3 rios
      • Culiacán, Sinaloa, Mexico, 80030
        • Hospital Civil De Culiacan (Site 6011), Avenida Álvaro Obregón 1422
    • Yucatán
      • Mérida, Yucatán, Mexico, 97000
        • Eme Red Hospitalaria (Site 6010), Calle 33 No. 496
      • Mérida, Yucatán, Mexico, 97070
        • Kohler and Milstein Research (Site 6013), Avenida Colón 197, García Ginerés
  • Philippines
    • Cavite
      • Cavite City, Cavite, Philippines, 4114
        • De La Salle Health Sciences Institute (Site 9504), Gov. Mangubat Avenue
    • National Capital Region
      • Makati City, National Capital Region, Philippines, 1229
        • Makati Medical Center (Site 9502), No. 2 Amorsolo Street, Legaspi Village
      • Muntinlupa, National Capital Region, Philippines, 1780
        • Asian Hospital and Medical Center (Site 9503), 2205 Civic Drive
  • Puerto Rico
      • San Juan, Puerto Rico, 00935
        • Puerto Rico AIDS Clinical Trials Unit (Site 1024), Proyecto ACTU Biomedical Building II
  • South Africa
      • George, South Africa, 6530
        • TASK Eden (Site 9218), G, 4 Victoria St.
      • Johannesburg, South Africa, 1619
        • CLINRESCO, ARWYP Medical Suites (Site 9209), 22 Pine Avenue
      • Mpumalanga, South Africa, 1055
        • Mzansi Ethical Research Centre (Site 9212), 184 Cowen Ntuli Street, Steve Tschwete
      • Pretoria, South Africa, 2000
        • Global Clinical Trials Sunnyside (Site 9216), 175 Steve Biko Street
    • Ekurhuleni, Gauteng
      • Kempton Park, Ekurhuleni, Gauteng, South Africa, 1619
        • Peermed Clinical Trial Center (Site 9215), Corner of Voortrekker and Monument Roads
    • Gauteng
      • Benoni, Gauteng, South Africa, 1501
        • Worthwhile Clinical Trials (Site 9214), No. 1 Mowbray Avenue
      • Johannesburg, Gauteng, South Africa, 1632
        • The Aurum Institute Tembisa Clinical Research Site (Site 9217), Cnr Flint Mazibuko / Rev RTJ Namane Drive
      • Johannesburg, Gauteng, South Africa, 1724
        • Roodepoort Medicross (Site 9220), 54 Ontdekkers Road
      • Johannesburg, Gauteng, South Africa, 1862
        • Soweto ACTG CRS (Site 9203), Chris Hani Road
      • Johannesburg, Gauteng, South Africa, 9092
        • Helen Joseph Hospital (Site 9201), Perth Road
      • Pretoria, Gauteng, South Africa, 0152
        • Setshaba Research Centre (Site 9205), 2088 Block H
      • Tshwane, Gauteng, South Africa, 181
        • Into Research (Site 9210), Totius Street
    • Kwazulu - Natal
      • Durban, Kwazulu - Natal, South Africa, 4052
        • Durban International Clinical Research Site (Site 9208), Sidmouth Avenue
    • Matjhabeng, Free State
      • Welkom, Matjhabeng, Free State, South Africa, 9459
        • Welkom Clinical Trial Centre (Site 9211), 189 Power Road
    • North-West
      • Klerksdorp, North-West, South Africa, 2571
        • The Aurum Institute Klerksdorp Clinical Research Center (Site 9204), Corner Margaretha Prinsloo St. and O.R. Tambo St.
      • Rustenburg, North-West, South Africa, 300
        • The Aurum Institute Rustenburg Clinical Research Site (Site 9202), 50 Steen St., c/o Pretorius St.
  • United States
    • Alabama
      • Anniston, Alabama, United States, 36207-5707
        • Pinnacle Research Group (Site 1082), 321 E. 10th Street
      • Athens, Alabama, United States, 35611-2456
        • North Alabama Research Center LLC (Site 1194), 721 W. Market St., Ste. B
      • Birmingham, Alabama, United States, 35294
        • University of Alabama at Birmingham (Site 1005), 908 20th Street South
      • Cullman, Alabama, United States, 35055-1921
        • Cullman Clinical Trials (Site 1140), 501 Clark St. NE.
      • Jasper, Alabama, United States, 35501-0102
        • Jasper Summit Research, LLC. (Site 1056), 1280 Summit
    • Arizona
      • Phoenix, Arizona, United States, 85051
        • Absolute Clinical Research, LLC. (Site 1186), 7725 North 43rd Avenue, Ste. 211
      • Tucson, Arizona, United States, 85724-0001
        • University of Arizona (Site 1043), 1501 N. Campbell Ave., Rm. 6410
    • California
      • Anaheim, California, United States, 92804-3729
        • Omnibus Clinical Research (Site 1253), 3340 W. Ball Road, Ste. I
      • Bakersfield, California, United States, 93301-1661
        • Franco A. Felizarta MD (Site 1174), 3535 San Dimas St.
      • Canyon Country, California, United States, 91351-4138
        • Clearview Medical Research LLC. (Site 1251), 2714 Hidaway Ave., Ste. 103
      • Fullerton, California, United States, 92835-3820
        • St. Jude Heritage Medical Group (Site 1093), 2151 N. Harbor Blvd.
      • La Jolla, California, United States, 92037
        • University of California San Diego (Site 1160), 9350 Campus Point Drive, Perlman Cancer Cancer
      • La Mesa, California, United States, 91942-7001
        • Fadi A. Haddad, MD, Inc. (Site 1146), 8860 Center Dr., Ste. 320
      • La Palma, California, United States, 90623
        • Atella Clinical Research (Site 1111), 5451 La Palma Avenue
      • Loma Linda, California, United States, 92354
        • Loma Linda University Health (Site 1110), 11374 Mountain View, Dover Bldg, Ste. C
      • Los Angeles, California, United States, 90033-1021
        • University of Southern California (Site 1057), 1300 N. Mission Rd., Rm 349
      • Los Angeles, California, United States, 90035
        • UCLA CARE Center (Site 1003), 11075 Santa Monica Blvd., Suite 100
      • Los Angeles, California, United States, 90094-2994
        • Science 37, Inc. (Site 1124), 12121 Bluff Creek Dr., Ste. 100
      • Mather, California, United States, 95655-4200
        • VA Northern California Health Care System (NAVREF) (Site 1137), 10535 Hospital Way
      • Modesto, California, United States, 95350-5365
        • Central Valley Research, LLC (Site 1085), 400 E. Orangeburg Ave., Ste. 5
      • Newport Beach, California, United States, 92663-4126
        • Hoag Memorial Hospital Presbyterian (Site 1200), 1 Hoag Dr.
      • Northridge, California, United States, 91325-4138
        • Valley Clinical Research, Inc. (Site 1059), 18433 Roscoe Blvd., Ste 210
      • Orange, California, United States, 92868
        • University of California Irvine (Site 1083), 843 Health Sciences Road
      • Oxnard, California, United States, 93030
        • FOMAT Medical Research (Site 1136), 300 South A Street
      • Rancho Mirage, California, United States, 92270-3221
        • Eisenhower Medical Center (Site 1040), 39000 Bob Hope Drive
      • Redding, California, United States, 96001-0172
        • Paradigm Research (Site 1150), 3652 Eureka Way
      • Riverside, California, United States, 92506-2658
        • Riverside Medical Clinic (Site 1232), 7117 Brockton Ave.
      • Sacramento, California, United States, 95817-2201
        • University of California Davis Medical Center (Site 1097), 2315 Stockton Blvd.
      • San Bernardino, California, United States, 92404
        • Premier Urgent Care Centers of California, Inc. (Site 1176), 284 E. Highland Ave.
      • San Diego, California, United States, 92103
        • University of California San Diego (Site 1002), 220 Dickinson Street
      • San Diego, California, United States, 92120
        • Zion Medical Center (Site 1063), 4647 Zion Avenue
      • San Diego, California, United States, 92161-0002
        • VA San Diego Health System (Stie 1127), 3350 La Jolla
      • San Francisco, California, United States, 94110
        • University of California San Francisco (Site 1009), 995 Potrero Ave., Building 80, Ward 84
      • San Francisco, California, United States, 94127-2606
        • San Francisco Research Institute (Site 1210), 2435 Ocean Ave.
      • Stanford, California, United States, 94305-5102
        • Stanford University (Site 1213), 1201 Welch Road
      • Thousand Oaks, California, United States, 91360-3994
        • Millennium Clinical Trials (Site 1260), 550 Saint Charles Dr., Ste. 208
      • Thousand Oaks, California, United States, 91360-8005
        • Office of Ramesh V. Nathan, MD (Site 1073), 2220 Lynn Rd., Ste. 301
      • Torrance, California, United States, 90502
        • Harbor UCLA (Site 1022), 1124 West Carson Street
      • Westminster, California, United States, 92683-4454
        • Allianz Research Institute Inc. (Site 1159), 14120 Beach Blvd., Ste. 101
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado (Site 1007), 12401 East 17th Avenue
    • Connecticut
      • Storrs, Connecticut, United States, 06269-1248
        • UConn - Institute for Collaboration on Health (Site 1169), 2006 Hillside Rd., Unit 1248
    • District of Columbia
      • Washington, District of Columbia, United States, 20009
        • Whitman-Walker Health (Site 1027), 1337 R Street NW.
    • Florida
      • Boynton Beach, Florida, United States, 33435-5610
        • Imagine Research of Palm Beach County (Site 1157), 709 S. Federal Hwy., Ste. 2
      • Bradenton, Florida, United States, 34205-1704
        • Bradenton Research Center Inc. (Site 1109), 3924 9th Ave. W
      • Bradenton, Florida, United States, 34208-1004
        • Synergy Healthcare (Site 1099), 300 Riverside Drive E., Ste. 1350
      • Daytona Beach, Florida, United States, 32117-5157
        • Cardiology Physicians, P.A. (Site 1180), 305 Memorial Medical Pkwy., Ste. 301
      • DeLand, Florida, United States, 32720-0920
        • Midland Florida Clinical Research Center LLC (Site 1130), 665 Peachwood Drive
      • Doral, Florida, United States, 33166-6508
        • Integrity Clinical Research (Site 1214), 3901 NW 79th Ave.
      • Doral, Florida, United States, 33166-6658
        • Universal Axon Clinical Research (Site 1077), 3650 NW 82nd Ave.
      • Fort Lauderdale, Florida, United States, 33308
        • EMINAT Research (Site 1202), 2500 E. Commercial Blvd.
      • Fort Lauderdale, Florida, United States, 33308
        • Holy Cross Health (Site 1072), 4725 North Federal Highway
      • Gainesville, Florida, United States, 32608-1135
        • North Florida / South Georgia Veterans Health System (Site 1133), 1601 SW Archer Rd.
      • Gainesville, Florida, United States, 32610-3003
        • University of Florida (Site 1047), 1600 SW. Archer Rd.
      • Gulf Breeze, Florida, United States, 32561
        • NW FL Clinical Research Group, LLC. (Site 1046), 400 Gulf Breeze Parkway
      • Hialeah, Florida, United States, 33012-4174
        • Indago Research and Health Center (Site 1050), 3700 W. 12th Ave., Ste. 300
      • Hialeah, Florida, United States, 33012
        • AGA Clinical Trials (Site 1026), 900 West 49th Street
      • Hialeah, Florida, United States, 33016-1811
        • Community Research of South Florida (Site 1197), 7100 W. 20th Ave., Ste. 403
      • Hialeah, Florida, United States, 33016-1895
        • New Generation Medical Research (Site 1204), 7600 W. 20th Ave., Ste. 106
      • Hialeah, Florida, United States, 33016-6890
        • Best Quality Research, Inc. (Site 1237), 2387 W. 68th St., Ste. 403
      • Hollywood, Florida, United States, 33024
        • Innovative Health Medical Center (Site 1222), 6750 Taft Street
      • Jacksonville, Florida, United States, 32209
        • University of Florida Jacksonville (Site 1039), 655 West 8th Street
      • Jacksonville, Florida, United States, 32224-1865
        • Mayo Clinic Jacksonville (Site 1149), 4500 San Pablo Rd. S.
      • Miami, Florida, United States, 33125
        • Gonzalez MD & Aswad MD Health Services (Site 1238), 3401 NW. 7th Street
      • Miami, Florida, United States, 33135-2906
        • Clintex Research Group, Inc. (Site 1231), 590 SW. 27th Ave.
      • Miami, Florida, United States, 33135-2968
        • Advance Medical Research Center (Site 1193) 330 SW. 27th Ave., Ste. 701
      • Miami, Florida, United States, 33136
        • University of Miami Miller School of Medicine CoVID Unit (Site 1068), 1425 NW. 10th Ave.
      • Miami, Florida, United States, 33155-2164
        • Florida International Medical Research (Site 1239), 1890 S. Red Rd., Ste. 103
      • Miami, Florida, United States, 33155-3244
        • D&H National Research Centers (Site 1205), 8485 Bird Road
      • Miami, Florida, United States, 33155-4630
        • Allied Biomedical Research Institute (Site 1227), 7100 SW. 47th St., Ste. 220
      • Miami, Florida, United States, 33155
        • Miami Clinical Research (Site 1089), 2400 SW. 69th Ave.
      • Miami, Florida, United States, 33173-4648
        • Research Institute of South Florida, Inc. (Site 1201), 9835 SW. 72nd Street, Ste. 201
      • Miami, Florida, United States, 33174-1746
        • RM Medical Research, Inc. (Site 1230), 10346 W. Flagler St.
      • Miami, Florida, United States, 33175-3437
        • Pro Live Medical Research Corp (Site 1219), 12781 SW. 42nd Street
      • Miami, Florida, United States, 33176-2230
        • Miami Dade Medical Research Institute, LLC (Site 1223), 8955 SW. 87th Ct.
      • Miami Beach, Florida, United States, 33140-3627
        • QC Trials (Site 1117), 300 W. 41st Street, Ste. 203
      • Miami Lakes, Florida, United States, 33014
        • Lakes Research (Site 1037), 5801 NW 151 Street
      • Miami Lakes, Florida, United States, 33014
        • Savin Medical Group, LLC. (Site 1212), 5789B NW. 151st Street
      • Miami Shores, Florida, United States, 33138
        • Amber Clinical Research, LLC. (Site 1206), 9000 NE. 2nd Avenue
      • North Bay Village, Florida, United States, 33141
        • Bravo Health Care Center (Site 1221), 1440 79 Street
      • Orlando, Florida, United States, 32803
        • Orlando Immunology Center (Site 1045), 1707 North Mills Avenue
      • Orlando, Florida, United States, 32819
        • Clintheory (Site 1203), 7350 Sandlake Commons Blvd.
      • Palmetto Bay, Florida, United States, 33157-5503
        • IMIC, Inc. (Site 1141), 18320 Franjo Rd
      • Pembroke Pines, Florida, United States, 33026-3240
        • Family Clinical Trials (Site 1236), 1601 N. Palm Ave., Ste. 102
      • Sarasota, Florida, United States, 34239-3132
        • Physician Care Clinical Research, LLC. (Site 1242), 1617 S. Tuttle Ave., Ste. 1A
      • Sebring, Florida, United States, 33870-1216
        • Bassetti Medical Research, Inc. (Site 1158), 5825 US Highway 27 N.
      • Tamarac, Florida, United States, 33321-2954
        • DBC Research (Site 1188), 7707 N. University Dr., Ste. 106
      • Tamarac, Florida, United States, 33342
        • ETNA Medical Center (Site 1225), 7401 N. University Drive
      • Tampa, Florida, United States, 33609-2230
        • Moore Clinical Research, Inc. (Site 1164), 4257 W. Kennedy Blvd.
      • Tampa, Florida, United States, 33610-1469
        • Tampa General Hospital Family Care Center Healthpark (Site 1088), 5802 N. 30th Street
      • Vero Beach, Florida, United States, 32960-4889
        • Infectious Disease Consultants of the Treasure Coast (Site 1171), 3735 11th Cir., Ste. 201
      • Vero Beach, Florida, United States, 32960
        • AIDS Research and Treatment Center of the Treasure Coast (Site 1095), 981 37th Place
      • West Palm Beach, Florida, United States, 33407-3100
        • Triple O Research Institute PA (Site 1121), 2580 Metrocentre Blvd., Ste. 4
    • Georgia
      • Atlanta, Georgia, United States, 30308
        • The Ponce de Leon Center (site 1015), 341 Ponce De Leon Avenue Northeast
      • Atlanta, Georgia, United States, 30318-2512
        • Rare Disease Research, LLC. (Site 1248), 1891 Howell Mill Rd.NW, Ste. B
      • Atlanta, Georgia, United States, 30328
        • Agile Clinical Rsearch Trials, LLC (Site 1051), 750 Hammond Drive
      • Buford, Georgia, United States, 30518-8802
        • Balanced Life Health Care Solutions/SKYCRNG (Site 1191), 2033 Buford Hwy., Ste. 109
      • Columbus, Georgia, United States, 31904
        • IACT Health (Site 1035), 800 Talbotton Road
      • Duluth, Georgia, United States, 30096
        • Clintheory (Site 1254), 4300 Pleasant Hill Road
      • Norcross, Georgia, United States, 30093
        • One Health Research Clinic, Inc. (Site 1250), 5880 Live Oak Pkwy, Ste. 160
      • Snellville, Georgia, United States, 30078-5779
        • Renew Health Clinical Research, LLC. (Site 1161), 1550 Janmar Rd.
    • Hawaii
      • Honolulu, Hawaii, United States, 96813
        • John A. Burns School of Medicine UH Clinics at Kakaako (Site 1177), 651 Ilalo St.
    • Idaho
      • Idaho Falls, Idaho, United States, 83404-7554
        • Snake River Research, PLLC (Site 1120), 2900 Cortez Ave.
    • Illinois
      • Burr Ridge, Illinois, United States, 60527-0872
        • Metro Infectious Disease Consultants (Site 1106), 901 McClintock Dr., Ste. 201
      • Chicago, Illinois, United States, 60607-4911
        • Chicago Clinical Research Institute (Site 1132), 611 W. Roosevelt Rd.
      • Chicago, Illinois, United States, 60611
        • Northwestern University (Site 1025), 645 North Michigan Ave
      • Chicago, Illinois, United States, 60612
        • Rush University Medical Center (Site 1017), 600 Paulina St.
      • Chicago, Illinois, United States, 60612
        • University of Illinois at Chicago (Site 1147), 835 South Wood Street
      • Chicago, Illinois, United States, 60637-1443
        • University of Chicago (Site 1064), 5841 S. Maryland Ave.
      • Chicago, Illinois, United States, 60640-2831
        • Great Lakes Clinical Trials (Site 1049), 5149 N. Ashland Ave.
    • Indiana
      • Brownsburg, Indiana, United States, 46112-2415
        • Investigators Research Group, LLC. (Site 1170), 321 E. Northfield Dr., Ste. 100
      • Indianapolis, Indiana, United States, 46202-5149
        • Roudebush VA Medical Center (Site 1217), 550 University Blvd
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • University of Kansas Medical Center (Site 1042), 3901 Rainbow Boulevard
    • Louisiana
      • Metairie, Louisiana, United States, 70006
        • MedPharmics (Site 1065), 3800 Houma Blvd.
      • Monroe, Louisiana, United States, 71201
        • Clinical Trials of America, LLC. (Site 1245) 3201 Armand Street
      • New Orleans, Louisiana, United States, 70112-2703
        • New Orleans Adolescent Trials Unit (Site 1028), 1440 Canal St., Suite 904
      • New Orleans, Louisiana, United States, 70112-3018
        • Louisiana State University Health Sciences Center (Site 1153), 2000 Canal Street
      • New Orleans, Louisiana, United States, 70121
        • Ochsner Clinic Foundation (Site 1218), 1514 Jefferson Highway
    • Maryland
      • Baltimore, Maryland, United States, 21201-1524
        • Baltimore VA Medical Center (Site 1258), 10 N. Greene St.
      • Baltimore, Maryland, United States, 21205
        • Johns Hopkins University (Site 1006), 1830 East Monument Street
      • Silver Spring, Maryland, United States, 20910-7500
        • Walter Reed Army Institute of Research (Site 1118), 503 Robert Grant Ave.
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital (Site 1016), 55 Fruit Street
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess Medical Center (Site 1166), 110 Francis Street
      • Boston, Massachusetts, United States, 02215
        • Brigham and Women's Hospital - Therapeutics Clinical Research Site (Site 1023), 75 Francis Street
      • Worcester, Massachusetts, United States, 01655-0002
        • University of Massachusetts Medical School (Site 1054), 55 Lake Avenue N.
    • Michigan
      • Dearborn, Michigan, United States, 48124
        • Vida Clinical Studies (Site 1244), 3815 Pelham Street
      • Farmington Hills, Michigan, United States, 48334-1566
        • Revive Research Institute (Site 1257), 32255 Northwestern Hwy.
      • Sterling Heights, Michigan, United States, 48312
        • Revival Research Corporation (Site 1256), 13409 East 14 Mile Road
    • Mississippi
      • Gulfport, Mississippi, United States, 39501
        • Memorial Hospital at Gulfport (Site 1104), 4500 13th Street
      • Gulfport, Mississippi, United States, 39503
        • MedPharmics, LLC. (Site 1032), 15190 Community Rd.
    • Missouri
      • Columbia, Missouri, United States, 65212-1000
        • University of Missouri Health Care System (Site 1224), 1 Hospital Drive
      • Hannibal, Missouri, United States, 63401
        • Hannibal Clinic (Site 1129), 100 Medical Drive
      • Saint Louis, Missouri, United States, 63110
        • Washington University School of Medicine (Site 1008), 620 South Taylor, Suite 200
    • Montana
      • Bozeman, Montana, United States, 59715-6911
        • Bozeman Health Deaconess Hospital (Site 1115), 931 Highland Blvd, Ste. 3103
      • Butte, Montana, United States, 59701-1652
        • Mercury Street Medical Group (Site 1074), 300 W. Mercury St.
    • Nebraska
      • Omaha, Nebraska, United States, 68114
        • Quality Clinical Research (Site 1112), 10040 Regency Circle
    • Nevada
      • Las Vegas, Nevada, United States, 89113-2215
        • Las Vegas Medical Research (Site 1048), 8530 W. Sunset Rd.
    • New Mexico
      • Santa Fe, New Mexico, United States, 87505
        • AXCES Research Group (Site 1152), 531 Harkle Road
    • New York
      • Bronx, New York, United States, 10451
        • Bronx Prevention Research Center (Site 1108), 390 East 158th Street
      • Bronx, New York, United States, 10451
        • Lincoln Hospital (Site 1092), 249 East 149th Street
      • Bronx, New York, United States, 10459-2417
        • Urban Health Plan, Inc. (Site 1243), 1065 Southern Blvd
      • Bronx, New York, United States, 10461
        • Jacobi Medical Center (Site 1105), 1400 Pelham Parkway South
      • Bronx, New York, United States, 10468
        • James J. Peters VA Medical Center (Site 1053), 130 West Kingsbridge Road
      • Brooklyn, New York, United States, 11219-2916
        • Maimonides Medical Center (Site 1138), 4802 10th Avenue
      • Buffalo, New York, United States, 14203
        • University at Buffalo, Emergency Medicine (Site 1172), 77 Goodell Street
      • Flushing, New York, United States, 11355-2205
        • Flushing Hospital Medical Center (Site 1067), 4500 Parsons Blvd
      • Jamaica, New York, United States, 11418-2832
        • Jamaica Hospital Medical Center (Site 1066), 8900 Van Wyck Expressway
      • New York, New York, United States, 10032
        • 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, 10065
        • Cornell Clinical Trials Unit (Site 1011), NewYork-Presbyterian Hospital-Weill Cornell Medical Center, 525 East 68th Street
      • Potsdam, New York, United States, 13676-1786
        • Canton-Potsdam Hospital (Site 1076), 50 Leroy Street
      • Rochester, New York, United States, 14642
        • University of Rochester (Site 1010), 601 Elmwood Ave
      • Stony Brook, New York, United States, 11794
        • SUNY Stony Brook NICHD (Site 1094), HSC L-02, Rm. 142 C
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27514
        • University of North Carolina at Chapel Hill (Site 1001), 130 Mason Farm Rd., Bioinformatics Bldg, 2nd Floor
      • Charlotte, North Carolina, United States, 38273-5716
        • Carolina Clinical Research (Site 1167), 9040 Nations Ford Rd.
      • Denver, North Carolina, United States, 28037
        • Research Carolina Elite (Site 1247), 7480 Waterside Loop Road, Suite 201
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center (Site 1041), 40 Duke Medicine Circle
      • Morehead City, North Carolina, United States, 28557
        • Carteret Medical Group, LLC. (Site 1249), 302 Medical Park Ct.
      • Winston-Salem, North Carolina, United States, 27157-0001
        • Wake Forest University Health Sciences (Site 1038), 1 Medical Center Boulevard
    • North Dakota
      • Fargo, North Dakota, United States, 58102-3641
        • Sanford Health (Site 1084), 801 Broadway N.
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • The Christ Hospital (Site 1119), 2123 Auburn Avenue
      • Cleveland, Ohio, United States, 44106-5083
        • Case Western Reserve University (Site 1033), 2061 Cornell Road
      • Cleveland, Ohio, United States, 44109-1900
        • MetroHealth Medical Center (Site 1195), 2500 Metrohealth Dr.
      • Columbus, Ohio, United States, 43210
        • Ohio State University Medical Center (Site 1020), 480 Medical Center Drive
      • Ohio City, Ohio, United States, 45219
        • Cincinnati CRS (Site 1004), University of Cincinnati, University Hospital, 200 Albert Sabin Way
      • Springboro, Ohio, United States, 45066-9168
        • STAT Research (Site 1107), 66 Remick Blvd.
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74104
        • Ascension St. John Clinical Research Institute (Site 1090), 1725 East 19th Street
    • Oregon
      • Portland, Oregon, United States, 97213-2933
        • Providence Portland Medical Center (Site 1098), 4805 NE. Glisan Street
      • Portland, Oregon, United States, 97227-1110
        • Kaiser Permanente Center for Health Research (Site 1079), 3800 N. Interstate Ave.
      • Portland, Oregon, United States, 97239-2964
        • Portland VA Medical Center (Site 1131), 3710 SW US Veterans Hospital Rd.
      • Portland, Oregon, United States, 97239-3015
        • Oregon Health and Science University (Site 1259), 3181 SW. 10th Avenue
    • Pennsylvania
      • Doylestown, Pennsylvania, United States, 18901-2554
        • Doylestown Hospital (Site 1122), 595 W. State Street
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania (Site 1031), 3400 Spruce Street
      • Pittsburgh, Pennsylvania, United States, 15213-3215
        • The University of Pittsburgh (Site 1018), 3471 5th Ave.
      • Pittsburgh, Pennsylvania, United States, 15240
        • Veterans Affairs Pittsburgh Healthcare System (Site 1070), University Drive C.
    • Rhode Island
      • Providence, Rhode Island, United States, 02906
        • The Miriam Hospital Clinical Research Site (1142), 164 Summit Avenue
    • South Carolina
      • Columbia, South Carolina, United States, 29204-2410
        • Medtrial, LLC (Site 1134), 1718 Saint Julian Pl., Ste. 2
      • West Columbia, South Carolina, United States, 29169
        • Clinovacare Medical Clinical Research Center (Site 1211), 160 Medical Circle Suite D
    • South Dakota
      • Rapid City, South Dakota, United States, 57701
        • American Indian Clinical Trials Research Network (Site 1148), 717 Meade Street
      • Sioux Falls, South Dakota, United States, 57105-0401
        • Sanford USD Medical Center (Site 1078), 1305 W. 18th St.
    • Tennessee
      • Franklin, Tennessee, United States, 37067
        • Clinical Trials Center of Middle Tennessee (Site 1183), 100 Covey Drive
      • Nashville, Tennessee, United States, 37204-4718
        • Vanderbilt Therapeutics Clinical Research (Site 1013), Vanderbilt Health One Hundred Oaks, 719 Thompson Ln., Ste 47183
    • Texas
      • Bellaire, Texas, United States, 77401-4516
        • Saint Hope Foundation Inc. (Site 1100), 6800 West Loop Street, Ste. 560
      • Boerne, Texas, United States, 78006
        • South Texas Medical Research Institute, Inc./TTS Research (Site 1198), 1420 River Road
      • Brownsville, Texas, United States, 78520-7256
        • PanAmerican Clinical Research, LLC. (Site 1069), 1416 Palm Blvd.
      • Dallas, Texas, United States, 75208
        • Trinity Health and Wellness Center (Site 1030), 219 Sunset Avenue
      • Dallas, Texas, United States, 75235
        • UT Southwestern HIV/ID Clinical Trials Unit (Site 1208), 1936 Amelia Court
      • Edinburg, Texas, United States, 78539
        • Doctors Hospital at Renaissance Health Institute for Research and Development (Site 1145), 5323 S. McColl Rd.
      • Galveston, Texas, United States, 77555-0001
        • Sealy Institute for Vaccine Sciences Clincial Trials Program (Site 1044), 400 Harborside Drive
      • Houston, Texas, United States, 77004-6938
        • Rheumatology Center of Houston (Site 1252), 1200 Binz St., Ste. 1495
      • Houston, Texas, United States, 77026-1967
        • Lyndon B. Johnson Hospital (Site 1014), 5656 Kelley Street
      • Houston, Texas, United States, 77030-1501
        • University of Texas Health Science Center at Houston (Site 1055), 6431 Fannin Street, Ste. 2.112
      • Houston, Texas, United States, 77030-2703
        • Houston Methodist Hospital (Site 1123), 6565 Fannin Street
      • Houston, Texas, United States, 77074-1603
        • Dynamic Medical Research Group (Site 1081), 8314 Southwest Fwy
      • Houston, Texas, United States, 77087
        • Fairway Medical Clinic (Site 1156), 4910 Telephone Road
      • Humble, Texas, United States, 77338
        • Houston Heart and Vascular Associates (Site 1215), 1485 FM 1960 Bypass R. E., Ste. 100
      • Mesquite, Texas, United States, 75149-2438
        • SMS Clincial Research, LLC. (Site 1060), 1210 N. Galloway Ave.
      • Red Oak, Texas, United States, 75154
        • Epic Medical Research, LLC (Site 1233), 106 Plaza Drive
      • San Antonio, Texas, United States, 78234-4504
        • San Antonio Military Medical Center (Site 1173), 3551 Roger Brooke Dr.
    • Virginia
      • Falls Church, Virginia, United States, 22042-3307
        • Inova Fairfax Medical Campus (Site 1029), 3300 Gallows Road
      • Richmond, Virginia, United States, 23226-3787
        • Clinical Research Partners LLC (Site 1196), 7110 Forest Ave., Ste. 201
    • Washington
      • Kirkland, Washington, United States, 98034-3013
        • EvergreenHealth (Site 1080), 12040 NE 128th Street, Ste MS-77
      • Seattle, Washington, United States, 98104
        • University of Washington ACTU (Site 1012), Harborview Medical Center, 325 9th Ave.
      • Spokane, Washington, United States, 99204-2312
        • Providence Medical Research Center (Site 1075), 105 W. 8th Ave., Ste. 6050W
    • West Virginia
      • Huntington, West Virginia, United States, 25704
        • Hershel Woody Williams VA Medical Center (Site 1128), 1540 Spring Valley Drive
      • Morgantown, West Virginia, United States, 26506-1200
        • West VA University, Mary Babb Randolph Cancer Center (Site 1178), 1 Medical Center Drive
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53219
        • Vida Clinical Studies (Site 1246), 5757 West Oklahoma Avenue
      • Milwaukee, Wisconsin, United States, 53226
        • Medical College of Wisconsin, Inc. (Site 1036), 8701 Watertown Plank Road
      • Wauwatosa, Wisconsin, United States, 53226-1304
        • Allegiance Research Specialists (Site 1162), 2645 N. Mayfair Rd., Ste. 200

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Signed informed consent.
  • Documentation of laboratory-confirmed SARS-CoV-2 infection, as determined by a molecular (nucleic acid) or antigen test from any respiratory tract specimen (e.g. oropharyngeal, nasopharyngeal (NP), or nasal swab, or saliva) collected ≤240 hours (10 days) prior to study entry. Laboratory-confirmed SARS-CoV-2 infection outside the US must be conducted at a DAIDS-approved laboratory.

  • Able to begin study treatment no later than 7 days from self-reported onset of COVID-19 related symptom(s) or measured fever, where the first day of symptoms is considered symptom day 0 and defined by the self-reported date of first reported sign/symptom from the following list:

    • subjective fever or feeling feverish
    • cough
    • shortness of breath or difficulty breathing at rest or with activity
    • sore throat
    • body pain or muscle pain/aches
    • fatigue
    • headache
    • chills
    • nasal obstruction or congestion
    • nasal discharge
    • loss of taste or smell
    • nausea or vomiting
    • diarrhea
    • temperature > 38°C (100.4°F)

  • One or more of the following signs/symptoms within 24 hours of participating in the study:

    • subjective fever or feeling feverish
    • cough
    • shortness of breath or difficulty breathing at rest or with activity
    • sore throat
    • body pain or muscle pain/aches
    • fatigue
    • headache
    • chills
    • nasal obstruction or congestion
    • nasal discharge
    • loss of taste or smell
    • nausea or vomiting
    • diarrhea
    • temperature > 38°C (100.4°F)
  • Oxygen levels of ≥92% obtained at rest (adjusted as needed for altitude) by study staff within 24 hours of study entry. For a potential participant who regularly receives chronic supplementary oxygen for an underlying lung condition, their oxygen saturation should be measured while on their standard home oxygen supplementation level.
  • Participant must agree not to participate in another clinical trial for the treatment of COVID-19 or SARS-CoV-2 during the study period until hospitalization or 28 days after the start of the study, whichever occurs first.
  • Meet the protocol definition of being at "higher" risk of progression to hospitalization or death (BRII-196/BRII-198).
  • In Phase III, meeting the protocol definition of being at "higher" risk of progression to hospitalization or death (SNG001, SAB-185, BMS 986414+BMS 986413)
  • For participants of reproductive potential, negative serum or urine pregnancy test within 48 hours prior to study entry by any clinic or laboratory that has a CLIA certification or its equivalent, or by a point of care (POC)/CLIA-waived test. Note: Participants not of reproductive potential are eligible without requiring the use of a contraceptive method (BRII-196/BRII-198. AZD7442 [IV], AZD7442 [IM], SNG001, Camostat, SAB-185, BMS 986414+BMS 986413).
  • Participants that engage in sexual activity that may lead to pregnancy in their partner must agree to either remain abstinent or use male contraceptives. They are strongly advised to inform their non-pregnant sexual partners of reproductive potential to use effective contraceptives for 24 weeks after investigational product is administered. Participants with pregnant partners should use condoms during vaginal intercourse through 24 weeks after investigational agent administration. Participants should refrain from sperm donation for 24 weeks after investigational agent administration (BRII-196/BRII-198, AZD7442 [IV], AZD7442 [IM], SAB-185).
  • Participants that engage in sexual activity that may lead to pregnancy in their partner must agree to either remain abstinent or use male contraceptives for 30 days after investigational agent administration. They are also strongly advised to inform their non-pregnant sexual partners of reproductive potential to sue effective contraceptives for 30 days after investigational agent is administered to the participant. Participants with pregnant partners should use condoms during vaginal intercourse through 30 days after last dose of investigational agent administration. Participants should refrain from sperm donation for 30 days after investigational agent administration (SNG001).
  • Participants that engage in sexual activity that may lead to pregnancy in their partner must agree to either remain abstinent or use male contraceptives. They are also strongly advised to inform their non-regnant sexual partners of reproductive potential to use effective contraceptives from study entry through 90 days after study treatment. Participants with pregnant partners should use condoms during vaginal intercourse from study entry through 90 days after the last dose of the study treatment. Participants should refrain from sperm donation from study entry through 90 days after the last dose of study treatment (Camostat).
  • If participating in sexual activity that could lead to pregnancy, participants who are of reproductive potential must agree to use effective contraception for 24 weeks after investigational agent is administered. This would include oral contraceptives, implanted contraceptives, implanted contraceptives, intrauterine devices, and barrier methods.
  • If participating in sexual activity that could lead to pregnancy, participants who are of reproductive potential must agree to use highly effective contraception for 24 weeks after investigational agent is administered (AZD7442 [IV], AZD7442 [IM], SAB-185).
  • If participating in sexual activity that could lead to pregnancy, participants who are of reproductive potential must agree to use effective contraception for 30 days after investigational agent is administered (SNG001).
  • If participating in sexual activity that could lead to pregnancy, participants who are of reproductive potential must agree to use effective contraception for 90 days after the last dose of treatment (Camostat).
  • If participating in sexual activity that could lead to pregnancy, participants who are of reproductive potential must agree to use highly effective contraception for at least 48 weeks after the investigational agent is administered (BMS 986414+BMS 986413).

Exclusion Criteria:

  • History of or current hospitalization for COVID-19.
  • For the current SARS-CoV-2 infection, any positive SARS-CoV-2 nucleic acid or antigen tests from any respiratory tract specimen collected > 240 hours prior to study entry.
  • Current need for hospitalization or immediate medical attention.
  • Use of any prohibited medication listed in the protocol and/or use of systemic or inhaled steroids for the purpose of COVID-19 treatment (new or increased dose from chronic baseline) within 30 days prior to study.
  • Receipt of convalescent COVID-19 plasma or other antibody-based anti-SARS-CoV-2 treatment or prophylaxis at any time prior to study entry.
  • Receipt of other investigational treatments for SARS-CoV-2 any time before participating in the study (not including drugs approved and taken for other conditions/diseases or COVID-19 vaccines).
  • Known allergy/sensitivity or hypersensitivity to study drug or placebo.
  • Any condition requiring surgery up to 7 days before participating in the study, or that is considered life threatening up to 30 days before participating in the study.
  • Currently pregnant or breastfeeding (BRII-196/BRII-198, AZD7442 [IV], AZD7442 [IM], SNG001, Camostat, SAB-185, BMS 986414+BMS 986413).
  • In phase II, meeting the protocol definition of being at "higher" risk of progression to hospitalization or death (AZD7442 [IV], AZD7442 [IM], SNG001, Camostat, SAB-185, BMS 986414+BMS 986413).
  • Inflammatory skin conditions that compromise the safety of intramuscular (IM) injections, or other overlying skin conditions or tattoos that would preclude the assessment of injection site reactions, per the discretion of the investigator (AZD7442 [IM]).
  • Inflammatory skin conditions that compromise the safety of subcutaneous (SC) injections, or other overlying skin conditions or tattoos that would preclude the assessment of infection site reactions, per the discretion of the investigator (BMS 986414+BMS 986413).
  • History of coagulopathy which, in the opinion of the investigator, would preclude IM injection, or use of oral or injectable anticoagulants (protocol provides more information on prohibited medications) (AZD7442 [IM]).
  • Use of or need for chronic supplemental oxygen (SNG001).
  • Known severe liver disease prior to enrollment (defined as ALT or AST > 5 times upper limit of normal or end stage liver disease with Child-Pugh Class C or Child-Pugh-Turcotte score ≥ 10) (Camostat).
  • Known severe kidney disease prior to enrollment (defined as estimated glomerular filtration rate (eGFR) <30 ml/min/1.73m² or on renal-replacement therapy such as peritoneal dialysis or hemodialysis (Camostat)

Other investigational drug protocol-defined inclusion/exclusion criteria may apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Bamlanivimab 7000 mg (Phase 2)
Administered by IV infusion.
Biological: bamlanivimab 7000mg
Administered by single IV infusion. Participants are no longer being randomized to this intervention.
Other Names:
  • LY3819253
Placebo Comparator: Bamlanivimab 7000mg Placebo (Phase 2)
Administered by IV infusion
Drug: Placebo for Bamlanivimab 7000mg
Commercially available 0.9% sodium chloride solution. Participants are no longer being randomized to this intervention.
Experimental: Bamlanivimab 700mg (Phase 2)
Administered by IV infusion
Biological: bamlanivimab 700mg
Administered by single IV infusion. Participants are no longer being randomized to this intervention.
Other Names:
  • LY3819253
Placebo Comparator: Bamlanivimab 700mg Placebo (Phase 2)
Administered by IV infusion
Drug: Placebo for Bamlanivimab 700mg
Commercially available 0.9% sodium chloride solution. Participants are no longer being randomized to this intervention.
Experimental: Bamlanivimab 700mg (Phase 3)
Administered by IV infusion
Biological: bamlanivimab 700mg
Administered by single IV infusion. Participants are no longer being randomized to this intervention.
Other Names:
  • LY3819253
Experimental: BRII-196+BRII-198 (Pooled Phase 2/3)
Administered by IV infusion
Biological: BRII-196+BRII-198
1000 mg (BRII-196)/1000 mg (BRII-198) combination therapy. Administered by consecutive IV infusions as single dose. Participants are no longer being randomized to this intervention.
Placebo Comparator: BRII-196+BRII-198 Placebo (Pooled Phase 2/3)
Administered by IV infusion
Drug: Placebo for BRII-196+BRII-198
Commercially available 0.9% sodium chloride solution. Participants are no longer being randomized to this intervention.
Experimental: AZD7442 (IV) (Phase 2)
Administered by IV infusion
Biological: AZD7442 (IV)
300 mg AZD7442 (150 mg AZD8895 + 150 mg AZD1061). Administered by IV infusion as single dose. Participants are no longer being randomized to this intervention.
Other Names:
  • AZD8895 + AZD1061
Experimental: AZD7442 (IM) (Phase 2)
Administered by IM injection
Biological: AZD7442 (IM)
Administered intramuscularly as 2 separate injections sequentially (300 mg AZD8895 then 300 mg AZD1061) for one dose. Injections administered in the side of the thigh, one injection in each thigh. Participants are no longer being randomized to this intervention.
Other Names:
  • AZD8895 + AZD1061
Experimental: SNG001 (Phase 2)
Administered by inhalation
Drug: SNG001
1.3 mL solution administered once daily for 14 days using Aerogen Ultra nebulizer (inhalation device). Participants are no longer being randomized to this intervention.
Experimental: Camostat (Phase 2)
Administered as oral tablets
Drug: Camostat
200 mg (2 x 100 mg) film-coated tablets administered orally every 6 hours for 7 days. Participants are no longer being randomized to this intervention.
Other Names:
  • FOY-305
  • camostat mesilate
  • camostat mesylate
Experimental: SAB-185 (low dose) (Phase 2)
Administered by IV infusion
Biological: SAB-185 (3,840 Units/kg)
Administered by IV infusion as single dose. Participants are no longer being randomized to this intervention.
Other Names:
  • Anti-SARS-CoV-2 Human Immunoglobulin Intravenous (Tc bovine-derived)
Experimental: SAB-185 (high dose) (Phase 2)
Administered by IV infusion
Biological: SAB-185 (10,240 Units/kg)
Administered by IV infusion as single dose. Participants are no longer being randomized to this intervention.
Other Names:
  • Anti-SARS-CoV-2 Human Immunoglobulin Intravenous (Tc bovine-derived)
Experimental: BMS 986414+BMS 986413 (Phase 2)
Administered as subcutaneous (SC) injections
Biological: BMS-986414 + BMS-986413
Administered subcutaneously (SC) as 4 separate injections for one dose (two injections of C135-LS 200mg and two injections of C144-SL 200mg). Participants are no longer being randomized to this intervention.
Other Names:
  • C135-LS + C144-LS
Placebo Comparator: AZD7442 (IV) Pooled Placebo (Phase 2)
Administered by IV infusion; shared placebo includes AZD7442 (IM) placebo and placebo from other comparator arms in the study.
Drug: Placebo for AZD7442 (IV)
Commercially available 0.9% sodium chloride solution. Participants are no longer being randomized to this intervention.
Placebo Comparator: AZD7442 (IM) Pooled Placebo (Phase 2)
Administered by IM injection; shared placebo includes AZD7442 (IV) placebo and placebo from other comparator arms in the study.
Drug: Placebo for AZD7442 (IM)
Commercially available 0.9% sodium chloride solution. Participants are no longer being randomized to this intervention.
Placebo Comparator: SNG001 Pooled Placebo (Phase 2)
Administered by inhalation; shared placebo includes placebo from other comparator arms in the study.
Drug: Placebo for SNG001
Trisodium citrate dihydrate, di-sodium hydrogen-phosphate, sodium dihydrogen-phosphate dihydrate, racemic methionine (DL-methionine) and water. 1.3 mL solution administered once daily for 14 days using Aerogen Ultra nebulizer (inhalation device). Participants are no longer being randomized to this intervention.
Placebo Comparator: Camostat Pooled Placebo (Phase 2)
Administered as oral tablets; shared placebo includes placebo from other comparator arms in the study.
Drug: Placebo for Camostat
200 mg (2 x 100 mg) film-coated tablets administered orally every 6 hours for 7 days. Participants are no longer being randomized to this intervention.
Placebo Comparator: SAB-185 (low dose) Pooled Placebo (Phase 2)
Administered by IV infusion; includes SAB-185 (high dose) placebo and placebo from other comparator arms in the study.
Drug: Placebo for SAB-185 (low dose)
Commercially available 0.9% sodium chloride solution. Participants are no longer being randomized to this intervention.
Experimental: SAB-185 (low dose) (Phase 3) Non-OMICRON population

Administered by IV infusion.

The "Non-Omicron subpopulation" enrolled under Protocol Version 7 was defined as all participants enrolled under Protocol Version 7 excluding those in the "Omicron subpopulation."

Omicron/Non-Omicron subpopulation definitions were updated in Version 10.0 of the Primary SAP to be based on the timing of emergence of the Omicron variant within the study population as follows:

  • Variant information from any sample (i.e., not just from samples obtained on day 0) could be used to assign a participant to the Omicron or non-Omicron Subpopulations.
  • For participants without variant information, those randomized under Protocol Version 7.0 on or after December 15, 2021 would be assigned to the Omicron Subpopulation, and those randomized on or before December 14, 2021 would be assigned to the Non-Omicron Subpopulation.
Biological: SAB-185 (3,840 Units/kg)
Administered by IV infusion as single dose. Participants are no longer being randomized to this intervention.
Other Names:
  • Anti-SARS-CoV-2 Human Immunoglobulin Intravenous (Tc bovine-derived)
Active Comparator: Casirivimab and Imdevimab (Phase 3) Non-OMICRON population

Administered by IV infusion.

The "Non-Omicron subpopulation" enrolled under Protocol Version 7 was defined as all participants enrolled under Protocol Version 7 excluding those in the "Omicron subpopulation."

Omicron/Non-Omicron subpopulation definitions were updated in Version 10.0 of the Primary SAP to be based on the timing of emergence of the Omicron variant within the study population as follows:

  • Variant information from any sample (i.e., not just from samples obtained on day 0) could be used to assign a participant to the Omicron or non-Omicron Subpopulations.
  • For participants without variant information, those randomized under Protocol Version 7.0 on or after December 15, 2021 would be assigned to the Omicron Subpopulation, and those randomized on or before December 14, 2021 would be assigned to the Non-Omicron Subpopulation.
Drug: CASIRIVIMAB + IMDEVIMAB
600 mg casirivimab and 600 mg imdevimab, administered together as single IV infusion as one-time dose at study entry. Participants are no longer being randomized to this intervention.
Other Names:
  • REGN10933 + REGN10987
  • REGN-COV2
Placebo Comparator: SAB-185 (high dose) Pooled Placebo (Phase 2)
Administered by IV infusion; includes SAB-185 (low dose) placebo and placebo from other comparator arms in the study.
Drug: Placebo for SAB-185 (high dose)
Commercially available 0.9% sodium chloride solution. Participants are no longer being randomized to this intervention.
Placebo Comparator: BMS 986414+BMS 986413 Pooled Placebo (Phase 2)
Administered as subcutaneous (SC) injections; shared placebo includes placebo from other comparator arms in the study.
Drug: Placebo for BMS-986414 + BMS-986413
Administered SC as 4 separate injections for one dose. Participants are no longer being randomized to this intervention.
Experimental: SAB-185 (low dose) (Phase 3) OMICRON population

Administered by IV infusion The "Omicron subpopulation" enrolled under Protocol v.7 was defined as (1) all participants randomized under Protocol v.7 infected with the Omicron variant as identified on sequencing of NP sample obtained on day 0, plus (2) all participants randomized under Protocol v.7 on/after December 26, 2021, who do not have variant information available from sample obtained on day 0.

Definitions were updated in Primary SAP v10.0 to be based on timing of emergence of Omicron variant within the study population as follows:

  • Variant information from any sample (i.e. not just from samples obtained on day 0) could be used to assign a participant to the Omicron or non-Omicron Subpopulations.
  • For participants without variant information, those randomized under Protocol v7 on or after December 15, 2021 would be assigned to the Omicron Subpopulation, and those randomized on or before December 14, 2021 would be assigned to the Non-Omicron Subpopulation.
Biological: SAB-185 (3,840 Units/kg)
Administered by IV infusion as single dose. Participants are no longer being randomized to this intervention.
Other Names:
  • Anti-SARS-CoV-2 Human Immunoglobulin Intravenous (Tc bovine-derived)
Active Comparator: Casirivimab and Imdevimab (Phase 3) OMICRON population

Administered by IV infusion The "Omicron subpopulation" enrolled under Protocol v.7 was defined as (1) all participants randomized under Protocol v.7 infected with the Omicron variant as identified on sequencing of NP sample obtained on day 0, plus (2) all participants randomized under Protocol v.7 on/after December 26, 2021, who do not have variant information available from sample obtained on day 0.

Definitions were updated in Primary SAP v10.0 to be based on timing of emergence of Omicron variant within the study population as follows:

  • Variant information from any sample (i.e. not just from samples obtained on day 0) could be used to assign a participant to the Omicron or non-Omicron Subpopulations.
  • For participants without variant information, those randomized under Protocol v7 on or after December 15, 2021 would be assigned to the Omicron Subpopulation, and those randomized on or before December 14, 2021 would be assigned to the Non-Omicron Subpopulation.
Drug: CASIRIVIMAB + IMDEVIMAB
600 mg casirivimab and 600 mg imdevimab, administered together as single IV infusion as one-time dose at study entry. Participants are no longer being randomized to this intervention.
Other Names:
  • REGN10933 + REGN10987
  • REGN-COV2

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
COVID-19 Symptom Duration (Phase 2)
Time Frame: Up to Day 28

Bamlanivimab arms:

Symptom duration=max. duration (days) across targeted symptoms including: feeling feverish, cough, shortness of breath/difficulty breathing at rest/with activity, sore throat, body pain/muscle pain/aches, fatigue, headache, chills, nasal obstruction/congestion, nasal discharge, nausea, vomiting, and diarrhea. Subjects who die on/before day 28 assigned symptom duration 29 days.

No scale. Min. value: 0 Days, Max. Value 29 Days. Higher value=worse health condition.

Non-Bamlanivimab arms:

13 symptoms (as for Bamlanivimab) scored daily as absent (score 0), mild (score 1), moderate (score 2) or severe (score 3). Symptom duration=time (days) from Day 0 (pre-treatment) to first of two consecutive days when all symptoms scored moderate/severe at Day 0 (pre-treatment) are scored mild/absent, AND all symptoms scored mild/absent at Day 0 (pre-treatment) are scored absent.

No scale. Min. value: 0 Days, Max. Value 26 Days. Higher value=worse health condition.
Up to Day 28
Quantification of SARS-CoV-2 RNA (Phase 2)
Time Frame: Day 3

Bamlanivimab Agent arms:

Measured as Detected or Undetected from staff-collected NP (nasopharyngeal) swabs. Lower Limit of Detection is 1.4 (log 10 copies/ml).

Non-Bamlanivimab Agent arms:

Measured as below Lower Limit of Quantification (LLoQ) or at/above LLoQ from staff-collected NP (nasopharyngeal) swabs. Lower Limit of Quantification is 2 (log 10 copies/ml).

SNG001 and SNG001 Pooled Placebo arm each exclude 6 participants, due to unsuitable sample specimen conditions.
Day 3
Quantification of SARS-CoV-2 RNA (Phase 2)
Time Frame: Day 7

Bamlanivimab Agent arms:

Measured as Detected or Undetected from staff-collected NP (nasopharyngeal) swabs. Lower Limit of Detection is 1.4 (log 10 copies/ml).

Non-Bamlanivimab Agent arms:

Measured as below Lower Limit of Quantification (LLoQ) or at/above LLoQ from staff-collected NP (nasopharyngeal) swabs. Lower Limit of Quantification is 2 (log 10 copies/ml).
Day 7
Quantification of SARS-CoV-2 RNA (Phase 2)
Time Frame: Day 14

Bamlanivimab Agent arms:

Measured as Detected or Undetected from staff-collected NP (nasopharyngeal) swabs. Lower Limit of Detection is 1.4 (log 10 copies/ml).

Non-Bamlanivimab Agent arms:

Measured as below Lower Limit of Quantification (LLoQ) or at/above LLoQ from staff-collected NP (nasopharyngeal) swabs. Lower Limit of Quantification is 2 (log 10 copies/ml).
Day 14
Proportion of Participants With New Adverse Event (AE) ≥ Grade 3 (Phase 3)
Time Frame: Thru Day 28

AE Severity: Adverse event Severity grading followed Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), corrected Version 2.1, July 2017, which can be found on the DAIDS RSC website at:

https://rsc.niaid.nih.gov/clinical-research-sites/daids-adverse-event-grading-tables.

  • Grade 1 indicates a mild event
  • Grade 2 indicates a moderate event
  • Grade 3 indicates a severe event
  • Grade 4 indicates a potentially life-threatening event
  • Grade 5 indicates death
Thru Day 28
Number of Participants With New Adverse Event (AE) ≥ Grade 3 (Phase 2)
Time Frame: Thru Day 28

AE Severity: Adverse event Severity grading followed Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), corrected Version 2.1, July 2017, which can be found on the DAIDS RSC website at:

https://rsc.niaid.nih.gov/clinical-research-sites/daids-adverse-event-grading-tables.

  • Grade 1 indicates a mild event
  • Grade 2 indicates a moderate event
  • Grade 3 indicates a severe event
  • Grade 4 indicates a potentially life-threatening event
  • Grade 5 indicates death
Thru Day 28
Cumulative Incidence of Death Due to Any Cause or Hospitalization Due to Any Cause (Phase 3)
Time Frame: Thru Day 28
Hospitalization defined as ≥24 hours of acute care in a hospital or similar acute care facility, including Emergency Rooms or temporary facilities instituted to address medical needs of those with severe COVID-19. An event is defined as first occurrence of hospitalization/death (i.e. if subject has multiple hospitalizations, only the first hospitalization is counted as an event). Therefore, an event can only occur once for a subject. Results are presented as number of events.
Thru Day 28

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Level of SARS-CoV-2 RNA From NP Swabs (Phase 2)
Time Frame: Thru Day 14
Measured from staff-collected NP swabs
Thru Day 14
Level of SARS-CoV-2 RNA From NP Swabs (Phase 3)
Time Frame: Day 3
Measured from staff-collected NP swabs
Day 3
Duration of Targeted Clinical COVID-19 Symptoms (Phases 2 and 3)
Time Frame: Thru Day 28
Duration defined as the number of days from start of investigational agent to the first of four consecutive days when all symptoms scored as absent. Targeted symptoms are: Feeling feverish; cough, shortness of breath or difficulty breathing; sore throat; body pain or muscle pain/aches; fatigue (low energy); headache, chills, nasal obstruction or congestion (stuffy nose); nasal discharge (runny nose); nausea or vomiting; and diarrhea. Each symptom is scored daily by the participant as absent (score 0), mild (1), moderate (2) or severe (3)
Thru Day 28
COVID-19 Symptom Severity Ranking (Phases 2 and 3)
Time Frame: From Day 0 thru Day 28

Symptoms scored daily as absent (score 0), mild (score 1), moderate (score 2) or severe (score 3). Symptoms: feeling feverish, cough, shortness of breath/difficulty breathing at rest/with activity, sore throat, body pain/muscle pain/aches, fatigue, headache, chills, nasal obstruction/congestion, nasal discharge, nausea, vomiting, and diarrhea. Subjects alive and never hospitalized through Day 28: Symptom Severity Ranking=subject-specific AUC (area under curve) joining daily total symptom score associated with COVID-19 disease, over time (through Day 28, counting Day 0 as first day), calculated by trapezoidal rule and rescaled for time by dividing by the total number of trapezoids. Subjects who died within Day 28: Assigned severity score 42; Subjects alive but remaining hospitalized at Day 28: Assigned severity score 41; Subjects alive but no longer hospitalized at Day 28: Assigned severity score 40.

Calculated Severity Score=scale of 0 to 42. Higher value=worse health condition.
From Day 0 thru Day 28
Proportion of Participants With ≥1 Worsening Symptom of COVID-19 (Phases 2 and 3)
Time Frame: Thru Day 28
Progression of one or more COVID-19-associated symptoms to a worse status than recorded in study diary at study entry, prior to start of investigational product or placebo
Thru Day 28
COVID-19 Symptom Duration (Phase 3)
Time Frame: Thru Day 28

Bamlanivimab arm:

Symptom duration=max. duration (days) across targeted symptoms including: feeling feverish, cough, shortness of breath/difficulty breathing at rest/with activity, sore throat, body pain/muscle pain/aches, fatigue, headache, chills, nasal obstruction/congestion, nasal discharge, nausea, vomiting, and diarrhea. Subjects who die on/before day 28 assigned symptom duration 29 days.

No scale. Min. value: 0 Days, Max. Value 29 Days. Higher value=worse health condition.

Non-Bamlanivimab arms:

13 symptoms (as for Bamlanivimab) scored daily as absent (score 0), mild (score 1), moderate (score 2) or severe (score 3). Symptom duration=time (days) from Day 0 (pre-treatment) to first of two consecutive days when all symptoms scored moderate/severe at Day 0 (pre-treatment) are scored mild/absent, AND all symptoms scored mild/absent at Day 0 (pre-treatment) are scored absent.

No scale. Min. value: 0 Days, Max. Value 26 Days. Higher value=worse health condition.
Thru Day 28
Quantification of SARS-CoV-2 RNA (Phase 3)
Time Frame: Day 3

Measured as Detected or Undetected from staff-collected NP (nasopharyngeal) swabs. Lower Limit of Detection is 1.4 (log 10 copies/ml).

Non-Bamlanivimab Agent arms:

Measured as below Lower Limit of Quantification (LLoQ) or at/above LLoQ from staff-collected NP (nasopharyngeal) swabs. Lower Limit of Quantification is 2 (log 10 copies/ml).
Day 3
Cumulative Incidence of Death From Any Cause or Hospitalization Due to Any Cause (Phase 2)
Time Frame: Thru Day 28
Hospitalization defined as ≥24 hours of acute care in a hospital or similar acute care facility, including Emergency Rooms or temporary facilities instituted to address medical needs of those with severe COVID-19. An event is defined as first occurrence of hospitalization/death (i.e. if subject has multiple hospitalizations, only the first hospitalization is counted as an event). Therefore, an event can only occur once for a subject. Results are presented as number of events.
Thru Day 28
Cumulative Incidence of Death From Any Cause, or Hospitalization Due to Any Cause Related to COVID-19 (Phase 3)
Time Frame: Thru Day 28
Hospitalizations due to any cause deemed unrelated to COVID-19 are excluded. Hospitalization defined as ≥24 hours of acute care in a hospital or similar acute care facility, including Emergency Rooms or temporary facilities instituted to address medical needs of those with severe COVID-19. An event is defined as first occurrence of hospitalization/death (i.e. if subject has multiple hospitalizations, only the first hospitalization is counted as an event). Therefore, an event can only occur once for a subject. Results are presented as number of events.
Thru Day 28
Time to Self-reported Return to Usual Health (a) (Phases 2 and 3)
Time Frame: Thru Day 28

Defined as the number of days from start of investigational treatment until the first of two consecutive days that a participant reported return to usual (pre-COVID-19) health as recorded in a participant's study diary.

Not analyzed for Bamlanivimab Phase 2 and Phase 3 arms.
Thru Day 28
Cumulative Incidence of Death Due to Any Cause or Hospitalization Due to Any Cause (Phases 2 and 3)
Time Frame: Day 0 thru Week 24
Hospitalization defined as ≥24 hours of acute care in a hospital or similar acute care facility, including Emergency Rooms or temporary facilities instituted to address medical needs of those with severe COVID-19. An event is defined as first occurrence of hospitalization/death (i.e. if subject has multiple hospitalizations, only the first hospitalization is counted as an event). Therefore, an event can only occur once for a subject. Results are presented as number of events.
Day 0 thru Week 24
Cumulative Incidence of Death Due to Any Cause or Hospitalization Due to Any Cause (Phases 2 and 3)
Time Frame: Day 0 thru Week 72
Not applicable to Bamlanivimab arms as these were only 24 week-long studies. Hospitalization defined as ≥24 hours of acute care in a hospital or similar acute care facility, including Emergency Rooms or temporary facilities instituted to address medical needs of those with severe COVID-19. An event is defined as first occurrence of hospitalization/death (i.e. if subject has multiple hospitalizations, only the first hospitalization is counted as an event). Therefore, an event can only occur once for a subject. Results are presented as number of events.
Day 0 thru Week 72
Oxygen Saturation Level (Phases 2 and 3)
Time Frame: Thru Day 28
Measured by pulse oximeter and categorized as <96% versus ≥96%. Analysis not performed for Bamlanivimab arms.
Thru Day 28
AUC of SARS-CoV-2 RNA From Site-collected NP Swabs (Phase 2)
Time Frame: Thru Day 14

Measured by area under the curve (AUC) and above assay lower limit of quantification of quantitative SARS-CoV-2 RNA over time.

Not analyzed for Bamlanivimab arms.
Thru Day 14
Proportion of Participants With New Adverse Event (AE) ≥ Grade 2 (Phases 2 and 3)
Time Frame: Thru Day 28
Thru Day 28
Proportion of Participants With New Adverse Event (AE) ≥ Grade 2 (Phases 2 and 3)
Time Frame: Thru Week 24
Thru Week 24
Proportion of Participants With New Adverse Event (AE) ≥ Grade 3 (Phases 2 and 3)
Time Frame: Thru Week 24
Thru Week 24
Time to Self-reported Return to Usual Health (b) (Phases 2 and 3)
Time Frame: Thru Day 28

Defined as the number of days from start of investigational treatment until the first of four consecutive days that a participant reported return to usual (pre-COVID-19) health as recorded in a participant's study diary.

Not collected for Bamlanivimab Phase 2 and Phase 3 arms.
Thru Day 28

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborators

Bristol-Myers Squibb
Eli Lilly and Company
AstraZeneca
SAb Biotherapeutics, Inc.
Synairgen Research Ltd.
Brii Biosciences Limited
Sagent Pharmaceuticals
Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections

Investigators

  • Study Chair: David Smith, MD, MAS, University of California, San Diego

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 19, 2020

Primary Completion (Actual)

April 7, 2022

Study Completion (Actual)

June 20, 2023

Study Registration Dates

First Submitted

August 17, 2020

First Submitted That Met QC Criteria

August 18, 2020

First Posted (Actual)

August 19, 2020

Study Record Updates

Last Update Posted (Actual)

August 2, 2024

Last Update Submitted That Met QC Criteria

August 1, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A5401/ACTIV-2
  • 38742 (Other Identifier: DAIDS-ES)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Individual patient level data are available from ACTIV-2 clinical trial in accessclinicaldata@NIAID, a NIAID cloud-based secure controlled access data platform that enables sharing of and access to data sets from clinical trials for basic and clinical research and requires a data access request and a signed data use agreement.

IPD Sharing Access Criteria

NIAID OCICB requires a Data Use Agreement be signed by investigators seeking to obtain the PUD.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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