AzTrials
AzTrials

CoronavirusPhase 2/3NCT04518410

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

A Phase 2/3 study testing bamlanivimab 7000mg, BRII-196+BRII-198 and AZD7442 (IV) in people with Coronavirus and Covid19, run by National Institute of Allergy and Infectious Diseases (NIAID) at 252 sites in 9 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Coronavirus, Covid19
What is being tested?
bamlanivimab 7000mg, BRII-196+BRII-198 and AZD7442 (IV)
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
4,044 participants
Where
252 sitesin 9 countries
Study dates
19 Aug 2020to 20 Jun 2023
Phase
Phase 2/3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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).

Who cannot join

  • 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).
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  • 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.

Trial locations and contacts

252 sites in 9 countries.

252 sites in 9 countries

United States207 sites

  • Omnibus Clinical Research (Site 1253), 3340 W. Ball Road, Ste. I

    Anaheim, California, 92804-3729

  • Pinnacle Research Group (Site 1082), 321 E. 10th Street

    Anniston, Alabama, 36207-5707

  • North Alabama Research Center LLC (Site 1194), 721 W. Market St., Ste. B

    Athens, Alabama, 35611-2456

  • The Ponce de Leon Center (site 1015), 341 Ponce De Leon Avenue Northeast

    Atlanta, Georgia, 30308

  • Rare Disease Research, LLC. (Site 1248), 1891 Howell Mill Rd.NW, Ste. B

    Atlanta, Georgia, 30318-2512

  • Agile Clinical Rsearch Trials, LLC (Site 1051), 750 Hammond Drive

    Atlanta, Georgia, 30328

  • University of Colorado (Site 1007), 12401 East 17th Avenue

    Aurora, Colorado, 80045

  • Franco A. Felizarta MD (Site 1174), 3535 San Dimas St.

    Bakersfield, California, 93301-1661

  • Baltimore VA Medical Center (Site 1258), 10 N. Greene St.

    Baltimore, Maryland, 21201-1524

  • Johns Hopkins University (Site 1006), 1830 East Monument Street

    Baltimore, Maryland, 21205

  • Saint Hope Foundation Inc. (Site 1100), 6800 West Loop Street, Ste. 560

    Bellaire, Texas, 77401-4516

  • University of Alabama at Birmingham (Site 1005), 908 20th Street South

    Birmingham, Alabama, 35294

  • South Texas Medical Research Institute, Inc./TTS Research (Site 1198), 1420 River Road

    Boerne, Texas, 78006

  • Massachusetts General Hospital (Site 1016), 55 Fruit Street

    Boston, Massachusetts, 02114

  • Beth Israel Deaconess Medical Center (Site 1166), 110 Francis Street

    Boston, Massachusetts, 02215

  • Brigham and Women's Hospital - Therapeutics Clinical Research Site (Site 1023), 75 Francis Street

    Boston, Massachusetts, 02215

  • Imagine Research of Palm Beach County (Site 1157), 709 S. Federal Hwy., Ste. 2

    Boynton Beach, Florida, 33435-5610

  • Bozeman Health Deaconess Hospital (Site 1115), 931 Highland Blvd, Ste. 3103

    Bozeman, Montana, 59715-6911

  • Bradenton Research Center Inc. (Site 1109), 3924 9th Ave. W

    Bradenton, Florida, 34205-1704

  • Synergy Healthcare (Site 1099), 300 Riverside Drive E., Ste. 1350

    Bradenton, Florida, 34208-1004

  • Maimonides Medical Center (Site 1138), 4802 10th Avenue

    Brooklyn, New York, 11219-2916

  • Investigators Research Group, LLC. (Site 1170), 321 E. Northfield Dr., Ste. 100

    Brownsburg, Indiana, 46112-2415

  • PanAmerican Clinical Research, LLC. (Site 1069), 1416 Palm Blvd.

    Brownsville, Texas, 78520-7256

  • University at Buffalo, Emergency Medicine (Site 1172), 77 Goodell Street

    Buffalo, New York, 14203

  • Balanced Life Health Care Solutions/SKYCRNG (Site 1191), 2033 Buford Hwy., Ste. 109

    Buford, Georgia, 30518-8802

  • Metro Infectious Disease Consultants (Site 1106), 901 McClintock Dr., Ste. 201

    Burr Ridge, Illinois, 60527-0872

  • Mercury Street Medical Group (Site 1074), 300 W. Mercury St.

    Butte, Montana, 59701-1652

  • Clearview Medical Research LLC. (Site 1251), 2714 Hidaway Ave., Ste. 103

    Canyon Country, California, 91351-4138

  • University of North Carolina at Chapel Hill (Site 1001), 130 Mason Farm Rd., Bioinformatics Bldg, 2nd Floor

    Chapel Hill, North Carolina, 27514

  • Carolina Clinical Research (Site 1167), 9040 Nations Ford Rd.

    Charlotte, North Carolina, 38273-5716

  • Chicago Clinical Research Institute (Site 1132), 611 W. Roosevelt Rd.

    Chicago, Illinois, 60607-4911

  • Northwestern University (Site 1025), 645 North Michigan Ave

    Chicago, Illinois, 60611

  • Rush University Medical Center (Site 1017), 600 Paulina St.

    Chicago, Illinois, 60612

  • University of Illinois at Chicago (Site 1147), 835 South Wood Street

    Chicago, Illinois, 60612

  • University of Chicago (Site 1064), 5841 S. Maryland Ave.

    Chicago, Illinois, 60637-1443

  • Great Lakes Clinical Trials (Site 1049), 5149 N. Ashland Ave.

    Chicago, Illinois, 60640-2831

  • The Christ Hospital (Site 1119), 2123 Auburn Avenue

    Cincinnati, Ohio, 45219

  • Case Western Reserve University (Site 1033), 2061 Cornell Road

    Cleveland, Ohio, 44106-5083

  • MetroHealth Medical Center (Site 1195), 2500 Metrohealth Dr.

    Cleveland, Ohio, 44109-1900

  • University of Missouri Health Care System (Site 1224), 1 Hospital Drive

    Columbia, Missouri, 65212-1000

  • Medtrial, LLC (Site 1134), 1718 Saint Julian Pl., Ste. 2

    Columbia, South Carolina, 29204-2410

  • IACT Health (Site 1035), 800 Talbotton Road

    Columbus, Georgia, 31904

  • Ohio State University Medical Center (Site 1020), 480 Medical Center Drive

    Columbus, Ohio, 43210

  • Cullman Clinical Trials (Site 1140), 501 Clark St. NE.

    Cullman, Alabama, 35055-1921

  • Trinity Health and Wellness Center (Site 1030), 219 Sunset Avenue

    Dallas, Texas, 75208

  • UT Southwestern HIV/ID Clinical Trials Unit (Site 1208), 1936 Amelia Court

    Dallas, Texas, 75235

  • Cardiology Physicians, P.A. (Site 1180), 305 Memorial Medical Pkwy., Ste. 301

    Daytona Beach, Florida, 32117-5157

  • Vida Clinical Studies (Site 1244), 3815 Pelham Street

    Dearborn, Michigan, 48124

  • Midland Florida Clinical Research Center LLC (Site 1130), 665 Peachwood Drive

    DeLand, Florida, 32720-0920

  • Research Carolina Elite (Site 1247), 7480 Waterside Loop Road, Suite 201

    Denver, North Carolina, 28037

  • Integrity Clinical Research (Site 1214), 3901 NW 79th Ave.

    Doral, Florida, 33166-6508

  • Universal Axon Clinical Research (Site 1077), 3650 NW 82nd Ave.

    Doral, Florida, 33166-6658

  • Doylestown Hospital (Site 1122), 595 W. State Street

    Doylestown, Pennsylvania, 18901-2554

  • Clintheory (Site 1254), 4300 Pleasant Hill Road

    Duluth, Georgia, 30096

  • Duke University Medical Center (Site 1041), 40 Duke Medicine Circle

    Durham, North Carolina, 27710

  • Doctors Hospital at Renaissance Health Institute for Research and Development (Site 1145), 5323 S. McColl Rd.

    Edinburg, Texas, 78539

  • Inova Fairfax Medical Campus (Site 1029), 3300 Gallows Road

    Falls Church, Virginia, 22042-3307

  • Sanford Health (Site 1084), 801 Broadway N.

    Fargo, North Dakota, 58102-3641

  • Revive Research Institute (Site 1257), 32255 Northwestern Hwy.

    Farmington Hills, Michigan, 48334-1566

  • Flushing Hospital Medical Center (Site 1067), 4500 Parsons Blvd

    Flushing, New York, 11355-2205

  • EMINAT Research (Site 1202), 2500 E. Commercial Blvd.

    Fort Lauderdale, Florida, 33308

  • Holy Cross Health (Site 1072), 4725 North Federal Highway

    Fort Lauderdale, Florida, 33308

  • Clinical Trials Center of Middle Tennessee (Site 1183), 100 Covey Drive

    Franklin, Tennessee, 37067

  • St. Jude Heritage Medical Group (Site 1093), 2151 N. Harbor Blvd.

    Fullerton, California, 92835-3820

  • North Florida / South Georgia Veterans Health System (Site 1133), 1601 SW Archer Rd.

    Gainesville, Florida, 32608-1135

  • University of Florida (Site 1047), 1600 SW. Archer Rd.

    Gainesville, Florida, 32610-3003

  • Sealy Institute for Vaccine Sciences Clincial Trials Program (Site 1044), 400 Harborside Drive

    Galveston, Texas, 77555-0001

  • NW FL Clinical Research Group, LLC. (Site 1046), 400 Gulf Breeze Parkway

    Gulf Breeze, Florida, 32561

  • Memorial Hospital at Gulfport (Site 1104), 4500 13th Street

    Gulfport, Mississippi, 39501

  • MedPharmics, LLC. (Site 1032), 15190 Community Rd.

    Gulfport, Mississippi, 39503

  • Hannibal Clinic (Site 1129), 100 Medical Drive

    Hannibal, Missouri, 63401

  • Indago Research and Health Center (Site 1050), 3700 W. 12th Ave., Ste. 300

    Hialeah, Florida, 33012-4174

  • AGA Clinical Trials (Site 1026), 900 West 49th Street

    Hialeah, Florida, 33012

  • Community Research of South Florida (Site 1197), 7100 W. 20th Ave., Ste. 403

    Hialeah, Florida, 33016-1811

  • New Generation Medical Research (Site 1204), 7600 W. 20th Ave., Ste. 106

    Hialeah, Florida, 33016-1895

  • Best Quality Research, Inc. (Site 1237), 2387 W. 68th St., Ste. 403

    Hialeah, Florida, 33016-6890

  • Innovative Health Medical Center (Site 1222), 6750 Taft Street

    Hollywood, Florida, 33024

  • John A. Burns School of Medicine UH Clinics at Kakaako (Site 1177), 651 Ilalo St.

    Honolulu, Hawaii, 96813

  • Rheumatology Center of Houston (Site 1252), 1200 Binz St., Ste. 1495

    Houston, Texas, 77004-6938

  • Lyndon B. Johnson Hospital (Site 1014), 5656 Kelley Street

    Houston, Texas, 77026-1967

  • University of Texas Health Science Center at Houston (Site 1055), 6431 Fannin Street, Ste. 2.112

    Houston, Texas, 77030-1501

  • Houston Methodist Hospital (Site 1123), 6565 Fannin Street

    Houston, Texas, 77030-2703

  • Dynamic Medical Research Group (Site 1081), 8314 Southwest Fwy

    Houston, Texas, 77074-1603

  • Fairway Medical Clinic (Site 1156), 4910 Telephone Road

    Houston, Texas, 77087

  • Houston Heart and Vascular Associates (Site 1215), 1485 FM 1960 Bypass R. E., Ste. 100

    Humble, Texas, 77338

  • Hershel Woody Williams VA Medical Center (Site 1128), 1540 Spring Valley Drive

    Huntington, West Virginia, 25704

  • Snake River Research, PLLC (Site 1120), 2900 Cortez Ave.

    Idaho Falls, Idaho, 83404-7554

  • Roudebush VA Medical Center (Site 1217), 550 University Blvd

    Indianapolis, Indiana, 46202-5149

  • University of Florida Jacksonville (Site 1039), 655 West 8th Street

    Jacksonville, Florida, 32209

  • Mayo Clinic Jacksonville (Site 1149), 4500 San Pablo Rd. S.

    Jacksonville, Florida, 32224-1865

  • Jamaica Hospital Medical Center (Site 1066), 8900 Van Wyck Expressway

    Jamaica, New York, 11418-2832

  • Jasper Summit Research, LLC. (Site 1056), 1280 Summit

    Jasper, Alabama, 35501-0102

  • University of Kansas Medical Center (Site 1042), 3901 Rainbow Boulevard

    Kansas City, Kansas, 66160

  • EvergreenHealth (Site 1080), 12040 NE 128th Street, Ste MS-77

    Kirkland, Washington, 98034-3013

  • University of California San Diego (Site 1160), 9350 Campus Point Drive, Perlman Cancer Cancer

    La Jolla, California, 92037

  • Fadi A. Haddad, MD, Inc. (Site 1146), 8860 Center Dr., Ste. 320

    La Mesa, California, 91942-7001

  • Atella Clinical Research (Site 1111), 5451 La Palma Avenue

    La Palma, California, 90623

  • Las Vegas Medical Research (Site 1048), 8530 W. Sunset Rd.

    Las Vegas, Nevada, 89113-2215

  • Loma Linda University Health (Site 1110), 11374 Mountain View, Dover Bldg, Ste. C

    Loma Linda, California, 92354

  • University of Southern California (Site 1057), 1300 N. Mission Rd., Rm 349

    Los Angeles, California, 90033-1021

  • UCLA CARE Center (Site 1003), 11075 Santa Monica Blvd., Suite 100

    Los Angeles, California, 90035

  • Science 37, Inc. (Site 1124), 12121 Bluff Creek Dr., Ste. 100

    Los Angeles, California, 90094-2994

  • VA Northern California Health Care System (NAVREF) (Site 1137), 10535 Hospital Way

    Mather, California, 95655-4200

  • SMS Clincial Research, LLC. (Site 1060), 1210 N. Galloway Ave.

    Mesquite, Texas, 75149-2438

  • MedPharmics (Site 1065), 3800 Houma Blvd.

    Metairie, Louisiana, 70006

  • Gonzalez MD & Aswad MD Health Services (Site 1238), 3401 NW. 7th Street

    Miami, Florida, 33125

  • Clintex Research Group, Inc. (Site 1231), 590 SW. 27th Ave.

    Miami, Florida, 33135-2906

  • Advance Medical Research Center (Site 1193) 330 SW. 27th Ave., Ste. 701

    Miami, Florida, 33135-2968

  • University of Miami Miller School of Medicine CoVID Unit (Site 1068), 1425 NW. 10th Ave.

    Miami, Florida, 33136

  • Florida International Medical Research (Site 1239), 1890 S. Red Rd., Ste. 103

    Miami, Florida, 33155-2164

  • D&H National Research Centers (Site 1205), 8485 Bird Road

    Miami, Florida, 33155-3244

  • Allied Biomedical Research Institute (Site 1227), 7100 SW. 47th St., Ste. 220

    Miami, Florida, 33155-4630

  • Miami Clinical Research (Site 1089), 2400 SW. 69th Ave.

    Miami, Florida, 33155

  • Research Institute of South Florida, Inc. (Site 1201), 9835 SW. 72nd Street, Ste. 201

    Miami, Florida, 33173-4648

  • RM Medical Research, Inc. (Site 1230), 10346 W. Flagler St.

    Miami, Florida, 33174-1746

  • Pro Live Medical Research Corp (Site 1219), 12781 SW. 42nd Street

    Miami, Florida, 33175-3437

  • Miami Dade Medical Research Institute, LLC (Site 1223), 8955 SW. 87th Ct.

    Miami, Florida, 33176-2230

  • QC Trials (Site 1117), 300 W. 41st Street, Ste. 203

    Miami Beach, Florida, 33140-3627

  • Lakes Research (Site 1037), 5801 NW 151 Street

    Miami Lakes, Florida, 33014

  • Savin Medical Group, LLC. (Site 1212), 5789B NW. 151st Street

    Miami Lakes, Florida, 33014

  • Amber Clinical Research, LLC. (Site 1206), 9000 NE. 2nd Avenue

    Miami Shores, Florida, 33138

  • Vida Clinical Studies (Site 1246), 5757 West Oklahoma Avenue

    Milwaukee, Wisconsin, 53219

  • Medical College of Wisconsin, Inc. (Site 1036), 8701 Watertown Plank Road

    Milwaukee, Wisconsin, 53226

  • Central Valley Research, LLC (Site 1085), 400 E. Orangeburg Ave., Ste. 5

    Modesto, California, 95350-5365

  • Clinical Trials of America, LLC. (Site 1245) 3201 Armand Street

    Monroe, Louisiana, 71201

  • Carteret Medical Group, LLC. (Site 1249), 302 Medical Park Ct.

    Morehead City, North Carolina, 28557

  • West VA University, Mary Babb Randolph Cancer Center (Site 1178), 1 Medical Center Drive

    Morgantown, West Virginia, 26506-1200

  • Vanderbilt Therapeutics Clinical Research (Site 1013), Vanderbilt Health One Hundred Oaks, 719 Thompson Ln., Ste 47183

    Nashville, Tennessee, 37204-4718

  • New Orleans Adolescent Trials Unit (Site 1028), 1440 Canal St., Suite 904

    New Orleans, Louisiana, 70112-2703

  • Louisiana State University Health Sciences Center (Site 1153), 2000 Canal Street

    New Orleans, Louisiana, 70112-3018

  • Ochsner Clinic Foundation (Site 1218), 1514 Jefferson Highway

    New Orleans, Louisiana, 70121

  • 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, 10032

  • Cornell Clinical Trials Unit (Site 1011), NewYork-Presbyterian Hospital-Weill Cornell Medical Center, 525 East 68th Street

    New York, New York, 10065

  • Hoag Memorial Hospital Presbyterian (Site 1200), 1 Hoag Dr.

    Newport Beach, California, 92663-4126

  • One Health Research Clinic, Inc. (Site 1250), 5880 Live Oak Pkwy, Ste. 160

    Norcross, Georgia, 30093

  • Bravo Health Care Center (Site 1221), 1440 79 Street

    North Bay Village, Florida, 33141

  • Valley Clinical Research, Inc. (Site 1059), 18433 Roscoe Blvd., Ste 210

    Northridge, California, 91325-4138

  • Cincinnati CRS (Site 1004), University of Cincinnati, University Hospital, 200 Albert Sabin Way

    Ohio City, Ohio, 45219

  • Quality Clinical Research (Site 1112), 10040 Regency Circle

    Omaha, Nebraska, 68114

  • University of California Irvine (Site 1083), 843 Health Sciences Road

    Orange, California, 92868

  • Orlando Immunology Center (Site 1045), 1707 North Mills Avenue

    Orlando, Florida, 32803

  • Clintheory (Site 1203), 7350 Sandlake Commons Blvd.

    Orlando, Florida, 32819

  • FOMAT Medical Research (Site 1136), 300 South A Street

    Oxnard, California, 93030

  • IMIC, Inc. (Site 1141), 18320 Franjo Rd

    Palmetto Bay, Florida, 33157-5503

  • Family Clinical Trials (Site 1236), 1601 N. Palm Ave., Ste. 102

    Pembroke Pines, Florida, 33026-3240

  • University of Pennsylvania (Site 1031), 3400 Spruce Street

    Philadelphia, Pennsylvania, 19104

  • Absolute Clinical Research, LLC. (Site 1186), 7725 North 43rd Avenue, Ste. 211

    Phoenix, Arizona, 85051

  • The University of Pittsburgh (Site 1018), 3471 5th Ave.

    Pittsburgh, Pennsylvania, 15213-3215

  • Veterans Affairs Pittsburgh Healthcare System (Site 1070), University Drive C.

    Pittsburgh, Pennsylvania, 15240

  • Providence Portland Medical Center (Site 1098), 4805 NE. Glisan Street

    Portland, Oregon, 97213-2933

  • Kaiser Permanente Center for Health Research (Site 1079), 3800 N. Interstate Ave.

    Portland, Oregon, 97227-1110

  • Portland VA Medical Center (Site 1131), 3710 SW US Veterans Hospital Rd.

    Portland, Oregon, 97239-2964

  • Oregon Health and Science University (Site 1259), 3181 SW. 10th Avenue

    Portland, Oregon, 97239-3015

  • Canton-Potsdam Hospital (Site 1076), 50 Leroy Street

    Potsdam, New York, 13676-1786

  • The Miriam Hospital Clinical Research Site (1142), 164 Summit Avenue

    Providence, Rhode Island, 02906

  • Eisenhower Medical Center (Site 1040), 39000 Bob Hope Drive

    Rancho Mirage, California, 92270-3221

  • American Indian Clinical Trials Research Network (Site 1148), 717 Meade Street

    Rapid City, South Dakota, 57701

  • Epic Medical Research, LLC (Site 1233), 106 Plaza Drive

    Red Oak, Texas, 75154

  • Paradigm Research (Site 1150), 3652 Eureka Way

    Redding, California, 96001-0172

  • Clinical Research Partners LLC (Site 1196), 7110 Forest Ave., Ste. 201

    Richmond, Virginia, 23226-3787

  • Riverside Medical Clinic (Site 1232), 7117 Brockton Ave.

    Riverside, California, 92506-2658

  • University of Rochester (Site 1010), 601 Elmwood Ave

    Rochester, New York, 14642

  • University of California Davis Medical Center (Site 1097), 2315 Stockton Blvd.

    Sacramento, California, 95817-2201

  • San Antonio Military Medical Center (Site 1173), 3551 Roger Brooke Dr.

    San Antonio, Texas, 78234-4504

  • Premier Urgent Care Centers of California, Inc. (Site 1176), 284 E. Highland Ave.

    San Bernardino, California, 92404

  • University of California San Diego (Site 1002), 220 Dickinson Street

    San Diego, California, 92103

  • Zion Medical Center (Site 1063), 4647 Zion Avenue

    San Diego, California, 92120

  • VA San Diego Health System (Stie 1127), 3350 La Jolla

    San Diego, California, 92161-0002

  • University of California San Francisco (Site 1009), 995 Potrero Ave., Building 80, Ward 84

    San Francisco, California, 94110

  • San Francisco Research Institute (Site 1210), 2435 Ocean Ave.

    San Francisco, California, 94127-2606

  • AXCES Research Group (Site 1152), 531 Harkle Road

    Santa Fe, New Mexico, 87505

  • Physician Care Clinical Research, LLC. (Site 1242), 1617 S. Tuttle Ave., Ste. 1A

    Sarasota, Florida, 34239-3132

  • University of Washington ACTU (Site 1012), Harborview Medical Center, 325 9th Ave.

    Seattle, Washington, 98104

  • Bassetti Medical Research, Inc. (Site 1158), 5825 US Highway 27 N.

    Sebring, Florida, 33870-1216

  • Walter Reed Army Institute of Research (Site 1118), 503 Robert Grant Ave.

    Silver Spring, Maryland, 20910-7500

  • Sanford USD Medical Center (Site 1078), 1305 W. 18th St.

    Sioux Falls, South Dakota, 57105-0401

  • Renew Health Clinical Research, LLC. (Site 1161), 1550 Janmar Rd.

    Snellville, Georgia, 30078-5779

  • Providence Medical Research Center (Site 1075), 105 W. 8th Ave., Ste. 6050W

    Spokane, Washington, 99204-2312

  • STAT Research (Site 1107), 66 Remick Blvd.

    Springboro, Ohio, 45066-9168

  • Washington University School of Medicine (Site 1008), 620 South Taylor, Suite 200

    St Louis, Missouri, 63110

  • Stanford University (Site 1213), 1201 Welch Road

    Stanford, California, 94305-5102

  • Revival Research Corporation (Site 1256), 13409 East 14 Mile Road

    Sterling Heights, Michigan, 48312

  • SUNY Stony Brook NICHD (Site 1094), HSC L-02, Rm. 142 C

    Stony Brook, New York, 11794

  • UConn - Institute for Collaboration on Health (Site 1169), 2006 Hillside Rd., Unit 1248

    Storrs, Connecticut, 06269-1248

  • DBC Research (Site 1188), 7707 N. University Dr., Ste. 106

    Tamarac, Florida, 33321-2954

  • ETNA Medical Center (Site 1225), 7401 N. University Drive

    Tamarac, Florida, 33342

  • Moore Clinical Research, Inc. (Site 1164), 4257 W. Kennedy Blvd.

    Tampa, Florida, 33609-2230

  • Tampa General Hospital Family Care Center Healthpark (Site 1088), 5802 N. 30th Street

    Tampa, Florida, 33610-1469

  • Bronx Prevention Research Center (Site 1108), 390 East 158th Street

    The Bronx, New York, 10451

  • Lincoln Hospital (Site 1092), 249 East 149th Street

    The Bronx, New York, 10451

  • Urban Health Plan, Inc. (Site 1243), 1065 Southern Blvd

    The Bronx, New York, 10459-2417

  • Jacobi Medical Center (Site 1105), 1400 Pelham Parkway South

    The Bronx, New York, 10461

  • James J. Peters VA Medical Center (Site 1053), 130 West Kingsbridge Road

    The Bronx, New York, 10468

  • Millennium Clinical Trials (Site 1260), 550 Saint Charles Dr., Ste. 208

    Thousand Oaks, California, 91360-3994

  • Office of Ramesh V. Nathan, MD (Site 1073), 2220 Lynn Rd., Ste. 301

    Thousand Oaks, California, 91360-8005

  • Harbor UCLA (Site 1022), 1124 West Carson Street

    Torrance, California, 90502

  • University of Arizona (Site 1043), 1501 N. Campbell Ave., Rm. 6410

    Tucson, Arizona, 85724-0001

  • Ascension St. John Clinical Research Institute (Site 1090), 1725 East 19th Street

    Tulsa, Oklahoma, 74104

  • Infectious Disease Consultants of the Treasure Coast (Site 1171), 3735 11th Cir., Ste. 201

    Vero Beach, Florida, 32960-4889

  • AIDS Research and Treatment Center of the Treasure Coast (Site 1095), 981 37th Place

    Vero Beach, Florida, 32960

  • Whitman-Walker Health (Site 1027), 1337 R Street NW.

    Washington D.C., District of Columbia, 20009

  • Allegiance Research Specialists (Site 1162), 2645 N. Mayfair Rd., Ste. 200

    Wauwatosa, Wisconsin, 53226-1304

  • Clinovacare Medical Clinical Research Center (Site 1211), 160 Medical Circle Suite D

    West Columbia, South Carolina, 29169

  • Triple O Research Institute PA (Site 1121), 2580 Metrocentre Blvd., Ste. 4

    West Palm Beach, Florida, 33407-3100

  • Allianz Research Institute Inc. (Site 1159), 14120 Beach Blvd., Ste. 101

    Westminster, California, 92683-4454

  • Wake Forest University Health Sciences (Site 1038), 1 Medical Center Boulevard

    Winston-Salem, North Carolina, 27157-0001

  • University of Massachusetts Medical School (Site 1054), 55 Lake Avenue N.

    Worcester, Massachusetts, 01655-0002

Other trials in United States

South Africa16 sites

  • Worthwhile Clinical Trials (Site 9214), No. 1 Mowbray Avenue

    Benoni, Gauteng, 1501

  • Durban International Clinical Research Site (Site 9208), Sidmouth Avenue

    Durban, KwaZulu-Natal, 4052

  • TASK Eden (Site 9218), G, 4 Victoria St.

    George, 6530

  • The Aurum Institute Tembisa Clinical Research Site (Site 9217), Cnr Flint Mazibuko / Rev RTJ Namane Drive

    Johannesburg, Gauteng, 1632

  • Roodepoort Medicross (Site 9220), 54 Ontdekkers Road

    Johannesburg, Gauteng, 1724

  • Soweto ACTG CRS (Site 9203), Chris Hani Road

    Johannesburg, Gauteng, 1862

  • Helen Joseph Hospital (Site 9201), Perth Road

    Johannesburg, Gauteng, 9092

  • CLINRESCO, ARWYP Medical Suites (Site 9209), 22 Pine Avenue

    Johannesburg, 1619

  • Peermed Clinical Trial Center (Site 9215), Corner of Voortrekker and Monument Roads

    Kempton Park, Ekurhuleni, Gauteng, 1619

  • The Aurum Institute Klerksdorp Clinical Research Center (Site 9204), Corner Margaretha Prinsloo St. and O.R. Tambo St.

    Klerksdorp, North West, 2571

  • Mzansi Ethical Research Centre (Site 9212), 184 Cowen Ntuli Street, Steve Tschwete

    Mpumalanga, 1055

  • Setshaba Research Centre (Site 9205), 2088 Block H

    Pretoria, Gauteng, 0152

  • Into Research (Site 9210), Totius Street

    Pretoria, Gauteng, 181

  • Global Clinical Trials Sunnyside (Site 9216), 175 Steve Biko Street

    Pretoria, 2000

  • The Aurum Institute Rustenburg Clinical Research Site (Site 9202), 50 Steen St., c/o Pretorius St.

    Rustenburg, North West, 300

  • Welkom Clinical Trial Centre (Site 9211), 189 Power Road

    Welkom, Matjhabeng, Free State, 9459

Other trials in South Africa

Brazil8 sites

  • Hospital Das Clinicas Da Universidade Federal de Minas Gerais (Site 4001), Avenida Alfredo Balena 190

    Belo Horizonte, Minas Gerais, 30130-100

  • SOM Federal University Minas Gerais Brazil (Site 4002), Avenida Alfredo Balena 190

    Belo Horizonte, Minas Gerais, 30130-100

  • Hospital Dia do Pulmão (Site 4007), Rua Engenheiro Paul Werner, 1141

    Blumenau, Santa Catarina, 89030-101

  • L2 Ip - Instituto de Pesquisas Clinicas Ltda (Site 4008), SGAS 613, Conjunto E, Lote 95, Sala 6

    Brasília, Federal District, 70200-730

  • Hospital Nossa Senhora da Conceicao (Site 4004), Avenida Francisco Trein 596

    Porto Alegre, Rio Grande do Sul, 91850-200

  • Hospital Das Clinicas da Faculdade de Medicina de Ribeirão Preto (Site 4003), Avenida Bandeirantes 3900, Campus Universitário

    Ribeirão Preto, São Paulo, 14048-900

  • Instituto de Pesquisa Clínica Evandro Chagas (Site 4005), Avenida Brasil, 4365

    Rio de Janeiro, 21040-360

  • Hospital E Maternidade Celso Pierro (Site 4006), Avenue John Boyd Dunlop S/n

    São Paulo, 13059-900

Other trials in Brazil

Mexico8 sites

  • Neurociencias Estudios Clinicos S.C. (Site 6008), Boulevard Alfonso G. Calderon, 2193 int 2 A desarrollo urbano 3 rios

    Culiacán, Sinaloa, 80020

  • Hospital Civil De Culiacan (Site 6011), Avenida Álvaro Obregón 1422

    Culiacán, Sinaloa, 80030

  • Instituto Jalisciense de Investigacion Clinica SA de CV (Site 6005), Penitenciaria Numero 20, Colonia Centro

    Guadalajara, Jalisco, 44100

  • Centro de Investigación Farmacéutica Especializada de Occidente (Site 6006), Av. Vallarta 1670, Piso 2 PH1, Colonia Americana

    Guadalajara, Jalisco, 44160

  • Eme Red Hospitalaria (Site 6010), Calle 33 No. 496

    Mérida, Yucatán, 97000

  • Kohler and Milstein Research (Site 6013), Avenida Colón 197, García Ginerés

    Mérida, Yucatán, 97070

  • Oaxaca Site Management Organization (Site 6004), Calle Humboldt 302, Colonia Centro

    Oaxaca, Mexico City, 68000

  • CIMAB SA de CV (Site 6002), Francisco I Madero 270 Sur

    Torreón, Coahuila, 27000

Other trials in Mexico

Argentina7 sites

  • Fundación Sanatorio Güemes (Site 3001), Francisco Acuña de Figueroa 1240

    Buenos Aires, Buenos Aires F.D., C1180AAX

  • Clínica Adventista Belgrano (Site 3007), Estomba 1710

    Buenos Aires, C1430EGF

  • Instituto Médico Platense (Site 3011), Avenida 51 335

    La Plata, Buenos Aires, B1900AVG

  • Instituto Ave Pulmo (Site 3006), Carlos M. Alvear 3345

    Mar del Plata, B7602DCK

  • Hospital Universitario Austral (Site 3004), Av. Juan Domingo Peron, Derqui

    Pilar, B1629ODT

  • Instituto Médico Río Cuarto (Site 3005), Hipólito Yrigoyen 1020

    Río Cuarto, Córdoba Province, 5800

  • Instituto Médico de la Fundación Estudios Clínicos (Site 3009), Italia 428

    Rosario, Santa Fe Province, S2013DTC

Other trials in Argentina

Philippines3 sites

  • De La Salle Health Sciences Institute (Site 9504), Gov. Mangubat Avenue

    Cavite City, Cavite, 4114

  • Makati Medical Center (Site 9502), No. 2 Amorsolo Street, Legaspi Village

    Makati City, National Capital Region, 1229

  • Asian Hospital and Medical Center (Site 9503), 2205 Civic Drive

    Muntinlupa, National Capital Region, 1780

Other trials in Philippines

Canada1 site

  • Medical Arts Health Research Group (Site 2003), 360-1855 Kirschner Rd.

    Kelowna, British Columbia, V1Y 4N7

Other trials in Canada

Guatemala1 site

  • Centro Medico Militar (Site 9401), Finca El Palomar, Acatan, Sta. Rosita Zona 16

    Guatemala City, 01011

Other trials in Guatemala

Puerto Rico1 site

  • Puerto Rico AIDS Clinical Trials Unit (Site 1024), Proyecto ACTU Biomedical Building II

    San Juan, 00935

Other trials in Puerto Rico

About this study

Official title: 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.

Read the 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).

Conditions
Coronavirus, Covid19
Being tested
bamlanivimab 7000mg, BRII-196+BRII-198, AZD7442 (IV), AZD7442 (IM), SNG001
Keywords
COVID-19, Coronavirus, COVID 19, Coronaviridae Infections, Coronavirus Infections, RNA Virus Infections, Virus Diseases, Nidovirales Infections, SARS-CoV-2, SARS Coronavirus, ACTIV-2, ACTIV2
Medical subject headings
Coronavirus Infections, COVID-19, Coronaviridae Infections, RNA Virus Infections, Virus Diseases, Nidovirales Infections, Severe Acute Respiratory Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • bamlanivimab 7000mgBiological

    Also called LY3819253

    Administered by single IV infusion. Participants are no longer being randomized to this intervention.

  • BRII-196+BRII-198Biological

    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.

  • AZD7442 (IV)Biological

    Also called AZD8895 + AZD1061

    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.

  • AZD7442 (IM)Biological

    Also called AZD8895 + AZD1061

    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.

  • SNG001Drug

    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.

  • CamostatDrug

    Also called FOY-305, camostat mesilate, camostat mesylate

    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.

  • BMS-986414 + BMS-986413Biological

    Also called C135-LS + C144-LS

    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.

  • SAB-185 (3,840 Units/kg)Biological

    Also called Anti-SARS-CoV-2 Human Immunoglobulin Intravenous (Tc bovine-derived)

    Administered by IV infusion as single dose. Participants are no longer being randomized to this intervention.

  • SAB-185 (10,240 Units/kg)Biological

    Also called Anti-SARS-CoV-2 Human Immunoglobulin Intravenous (Tc bovine-derived)

    Administered by IV infusion as single dose. Participants are no longer being randomized to this intervention.

  • CASIRIVIMAB + IMDEVIMABDrug

    Also called REGN10933 + REGN10987, REGN-COV2

    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.

  • Placebo for Bamlanivimab 7000mgDrug

    Commercially available 0.9% sodium chloride solution. Participants are no longer being randomized to this intervention.

  • Placebo for Bamlanivimab 700mgDrug

    Commercially available 0.9% sodium chloride solution. Participants are no longer being randomized to this intervention.

  • Placebo for BRII-196+BRII-198Drug

    Commercially available 0.9% sodium chloride solution. Participants are no longer being randomized to this intervention.

  • Placebo for SNG001Drug

    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 for CamostatDrug

    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 for SAB-185 (low dose)Drug

    Commercially available 0.9% sodium chloride solution. Participants are no longer being randomized to this intervention.

  • Placebo for BMS-986414 + BMS-986413Drug

    Administered SC as 4 separate injections for one dose. Participants are no longer being randomized to this intervention.

  • Placebo for AZD7442 (IV)Drug

    Commercially available 0.9% sodium chloride solution. Participants are no longer being randomized to this intervention.

  • Placebo for AZD7442 (IM)Drug

    Commercially available 0.9% sodium chloride solution. Participants are no longer being randomized to this intervention.

  • Placebo for SAB-185 (high dose)Drug

    Commercially available 0.9% sodium chloride solution. Participants are no longer being randomized to this intervention.

  • bamlanivimab 700mgBiological

    Also called LY3819253

    Administered by single IV infusion. Participants are no longer being randomized to this intervention.

Study groups in NCT04518410
Study groupRoleWhat they receive
Bamlanivimab 7000 mg (Phase 2)ExperimentalAdministered by IV infusion.
Receives: Biological: bamlanivimab 7000mg
Bamlanivimab 7000mg Placebo (Phase 2)Placebo comparatorAdministered by IV infusion
Receives: Drug: Placebo for Bamlanivimab 7000mg
Bamlanivimab 700mg (Phase 2)ExperimentalAdministered by IV infusion
Receives: Biological: bamlanivimab 700mg
Bamlanivimab 700mg Placebo (Phase 2)Placebo comparatorAdministered by IV infusion
Receives: Drug: Placebo for Bamlanivimab 700mg
Bamlanivimab 700mg (Phase 3)ExperimentalAdministered by IV infusion
Receives: Biological: bamlanivimab 700mg
BRII-196+BRII-198 (Pooled Phase 2/3)ExperimentalAdministered by IV infusion
Receives: Biological: BRII-196+BRII-198
BRII-196+BRII-198 Placebo (Pooled Phase 2/3)Placebo comparatorAdministered by IV infusion
Receives: Drug: Placebo for BRII-196+BRII-198
AZD7442 (IV) (Phase 2)ExperimentalAdministered by IV infusion
Receives: Biological: AZD7442 (IV)
AZD7442 (IV) Pooled Placebo (Phase 2)Placebo comparatorAdministered by IV infusion; shared placebo includes AZD7442 (IM) placebo and placebo from other comparator arms in the study.
Receives: Drug: Placebo for AZD7442 (IV)
AZD7442 (IM) (Phase 2)ExperimentalAdministered by IM injection
Receives: Biological: AZD7442 (IM)
AZD7442 (IM) Pooled Placebo (Phase 2)Placebo comparatorAdministered by IM injection; shared placebo includes AZD7442 (IV) placebo and placebo from other comparator arms in the study.
Receives: Drug: Placebo for AZD7442 (IM)
SNG001 (Phase 2)ExperimentalAdministered by inhalation
Receives: Drug: SNG001
SNG001 Pooled Placebo (Phase 2)Placebo comparatorAdministered by inhalation; shared placebo includes placebo from other comparator arms in the study.
Receives: Drug: Placebo for SNG001
Camostat (Phase 2)ExperimentalAdministered as oral tablets
Receives: Drug: Camostat
Camostat Pooled Placebo (Phase 2)Placebo comparatorAdministered as oral tablets; shared placebo includes placebo from other comparator arms in the study.
Receives: Drug: Placebo for Camostat
SAB-185 (low dose) (Phase 2)ExperimentalAdministered by IV infusion
Receives: Biological: SAB-185 (3,840 Units/kg)
SAB-185 (low dose) Pooled Placebo (Phase 2)Placebo comparatorAdministered by IV infusion; includes SAB-185 (high dose) placebo and placebo from other comparator arms in the study.
Receives: Drug: Placebo for SAB-185 (low dose)
SAB-185 (low dose) (Phase 3) Non-OMICRON populationExperimentalAdministered 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.
Receives: Biological: SAB-185 (3,840 Units/kg)
Casirivimab and Imdevimab (Phase 3) Non-OMICRON populationActive comparatorAdministered 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.
Receives: Drug: CASIRIVIMAB + IMDEVIMAB
SAB-185 (high dose) (Phase 2)ExperimentalAdministered by IV infusion
Receives: Biological: SAB-185 (10,240 Units/kg)
SAB-185 (high dose) Pooled Placebo (Phase 2)Placebo comparatorAdministered by IV infusion; includes SAB-185 (low dose) placebo and placebo from other comparator arms in the study.
Receives: Drug: Placebo for SAB-185 (high dose)
BMS 986414+BMS 986413 (Phase 2)ExperimentalAdministered as subcutaneous (SC) injections
Receives: Biological: BMS-986414 + BMS-986413
BMS 986414+BMS 986413 Pooled Placebo (Phase 2)Placebo comparatorAdministered as subcutaneous (SC) injections; shared placebo includes placebo from other comparator arms in the study.
Receives: Drug: Placebo for BMS-986414 + BMS-986413
SAB-185 (low dose) (Phase 3) OMICRON populationExperimentalAdministered 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.
Receives: Biological: SAB-185 (3,840 Units/kg)
Casirivimab and Imdevimab (Phase 3) OMICRON populationActive comparatorAdministered 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.
Receives: Drug: CASIRIVIMAB + IMDEVIMAB

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. COVID-19 Symptom Duration (Phase 2)

    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.

    Measured: Up to Day 28

  2. Quantification of SARS-CoV-2 RNA (Phase 2)

    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.

    Measured: Day 3

  3. Quantification of SARS-CoV-2 RNA (Phase 2)

    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).

    Measured: Day 7

  4. Quantification of SARS-CoV-2 RNA (Phase 2)

    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).

    Measured: Day 14

  5. Number of Participants With New Adverse Event (AE) ≥ Grade 3 (Phase 2)

    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

    Measured: Thru Day 28

  6. Cumulative Incidence of Death Due to Any Cause or Hospitalization Due to Any Cause (Phase 3)

    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.

    Measured: Thru Day 28

  7. Proportion of Participants With New Adverse Event (AE) ≥ Grade 3 (Phase 3)

    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

    Measured: Thru Day 28

Secondary outcomes (18)

  1. COVID-19 Symptom Duration (Phase 3)

    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.

    Measured: Thru Day 28

  2. Quantification of SARS-CoV-2 RNA (Phase 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).

    Measured: Day 3

  3. Cumulative Incidence of Death From Any Cause or Hospitalization Due to Any Cause (Phase 2)

    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.

    Measured: Thru Day 28

  4. Cumulative Incidence of Death From Any Cause, or Hospitalization Due to Any Cause Related to COVID-19 (Phase 3)

    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.

    Measured: Thru Day 28

  5. Level of SARS-CoV-2 RNA From NP Swabs (Phase 2)

    Measured from staff-collected NP swabs

    Measured: Thru Day 14

  6. Level of SARS-CoV-2 RNA From NP Swabs (Phase 3)

    Measured from staff-collected NP swabs

    Measured: Day 3

  7. Duration of Targeted Clinical COVID-19 Symptoms (Phases 2 and 3)

    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)

    Measured: Thru Day 28

  8. COVID-19 Symptom Severity Ranking (Phases 2 and 3)

    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.

    Measured: From Day 0 thru Day 28

  9. Proportion of Participants With ≥1 Worsening Symptom of COVID-19 (Phases 2 and 3)

    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

    Measured: Thru Day 28

  10. Time to Self-reported Return to Usual Health (a) (Phases 2 and 3)

    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.

    Measured: Thru Day 28

  11. Cumulative Incidence of Death Due to Any Cause or Hospitalization Due to Any Cause (Phases 2 and 3)

    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.

    Measured: Day 0 thru Week 24

  12. Cumulative Incidence of Death Due to Any Cause or Hospitalization Due to Any Cause (Phases 2 and 3)

    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.

    Measured: Day 0 thru Week 72

  13. Oxygen Saturation Level (Phases 2 and 3)

    Measured by pulse oximeter and categorized as <96% versus ≥96%. Analysis not performed for Bamlanivimab arms.

    Measured: Thru Day 28

  14. AUC of SARS-CoV-2 RNA From Site-collected NP Swabs (Phase 2)

    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.

    Measured: Thru Day 14

  15. Proportion of Participants With New Adverse Event (AE) ≥ Grade 2 (Phases 2 and 3)

    Measured: Thru Day 28

  16. Proportion of Participants With New Adverse Event (AE) ≥ Grade 2 (Phases 2 and 3)

    Measured: Thru Week 24

  17. Proportion of Participants With New Adverse Event (AE) ≥ Grade 3 (Phases 2 and 3)

    Measured: Thru Week 24

  18. Time to Self-reported Return to Usual Health (b) (Phases 2 and 3)

    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.

    Measured: Thru Day 28

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Aug 2020
  2. Study start19 Aug 2020
  3. Primary completion7 Apr 2022
  4. Study completion20 Jun 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
4,044 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04518410
Sponsor's protocol ID
A5401/ACTIV-2
Other IDs
38742
Status last verified
Aug 2024
First submitted
17 Aug 2020
Last updated
2 Aug 2024
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • Currier JS, Moser C, Eron JJ, Chew KW, Smith DM, Javan AC, Wohl DA, Daar ES, Hughes MD; ACTIV-2/A5401 Study Team. ACTIV-2: A Platform Trial for the Evaluation of Novel Therapeutics for the Treatment of Early COVID-19 in Outpatients. J Infect Dis. 2023 Aug 31;228(Suppl 2):S77-S82. doi: 10.1093/infdis/jiad246.

    PubMed 37650231

  • Chew KW, Moser C, Yeh E, Wohl DA, Daar ES, Ritz J, Javan AC, Eron JJ, Currier JS, Smith DM, Hughes MD; ACTIV-2/A5401 Study Team. Validity and Characterization of Time to Symptom Resolution Outcome Measures in the ACTIV-2/A5401 Outpatient COVID-19 Treatment Trial. J Infect Dis. 2023 Aug 31;228(Suppl 2):S83-S91. doi: 10.1093/infdis/jiad300.

    PubMed 37650237

  • Moser CB, Chew KW, Ritz J, Newell M, Javan AC, Eron JJ, Daar ES, Wohl DA, Currier JS, Smith DM, Hughes MD; ACTIV-2/A5401 Study Team. Pooling Different Placebos as a Control Group in a Randomized Platform Trial: Benefits and Challenges From Experience in the ACTIV-2 COVID-19 Trial. J Infect Dis. 2023 Aug 31;228(Suppl 2):S92-S100. doi: 10.1093/infdis/jiad209.

    PubMed 37650234

  • Moser CB, Chew KW, Giganti MJ, Li JZ, Aga E, Ritz J, Greninger AL, Javan AC, Bender Ignacio R, Daar ES, Wohl DA, Currier JS, Eron JJ, Smith DM, Hughes MD; ACTIV-2/A5401 Study Team. Statistical Challenges When Analyzing SARS-CoV-2 RNA Measurements Below the Assay Limit of Quantification in COVID-19 Clinical Trials. J Infect Dis. 2023 Aug 31;228(Suppl 2):S101-S110. doi: 10.1093/infdis/jiad285.

    PubMed 37650235

  • Bender Ignacio RA, Wohl DA, Arends R, Pilla Reddy V, Mu Y, Javan AC, Hughes MD, Eron JJ, Currier JS, Smith D, Chew KW, Gibbs M, Fletcher CV. Comparative Pharmacokinetics of Tixagevimab/Cilgavimab (AZD7442) Administered Intravenously Versus Intramuscularly in Symptomatic SARS-CoV-2 Infection. Clin Pharmacol Ther. 2022 Dec;112(6):1207-1213. doi: 10.1002/cpt.2706. Epub 2022 Jul 26.

    PubMed 35797235

  • Boucau J, Chew KW, Choudhary MC, Deo R, Regan J, Flynn JP, Crain CR, Hughes MD, Ritz J, Moser C, Dragavon JA, Javan AC, Nirula A, Klekotka P, Greninger AL, Coombs RW, Fischer WA 2nd, Daar ES, Wohl DA, Eron JJ, Currier JS, Smith DM; POSITIVES study team; Li JZ, Barczak AK; ACTIV-2/A5401 Study Team. Monoclonal antibody treatment drives rapid culture conversion in SARS-CoV-2 infection. Cell Rep Med. 2022 Jul 19;3(7):100678. doi: 10.1016/j.xcrm.2022.100678. Epub 2022 Jun 20.

    PubMed 35793677

  • Chew KW, Moser C, Daar ES, Wohl DA, Li JZ, Coombs RW, Ritz J, Giganti M, Javan AC, Li Y, Choudhary MC, Deo R, Malvestutto C, Klekotka P, Price K, Nirula A, Fischer W, Bala V, Ribeiro RM, Perelson AS, Fletcher CV, Eron JJ, Currier JS; ACTIV-2/A5401 Study Team; Hughes MD, Smith DM. Antiviral and clinical activity of bamlanivimab in a randomized trial of non-hospitalized adults with COVID-19. Nat Commun. 2022 Aug 22;13(1):4931. doi: 10.1038/s41467-022-32551-2.

    PubMed 35995785

  • Li Y, Harrison LJ, Chew KW, Currier JS, Wohl DA, Daar ES, Evering TH, Wu R, Giganti M, Ritz J, Javan AC, Coombs RW, Moser C, Hughes MD, Eron JJ, Smith DM, Li JZ. Nasal and Plasma Severe Acute Respiratory Syndrome Coronavirus 2 RNA Levels Are Associated With Timing of Symptom Resolution in the ACTIV-2 Trial of Nonhospitalized Adults With Coronavirus Disease 2019. Clin Infect Dis. 2023 Feb 18;76(4):734-737. doi: 10.1093/cid/ciac818.

    PubMed 36210483

  • Smith DM, Li JZ, Moser C, Yeh E, Currier JS, Chew KW, Hughes MD; ACTIV-2/A5401 Study Team. Recurrence of Symptoms Following a 2-Day Symptom Free Period in Patients With COVID-19. JAMA Netw Open. 2022 Oct 3;5(10):e2238867. doi: 10.1001/jamanetworkopen.2022.38867.

    PubMed 36301549

  • Choudhary MC, Chew KW, Deo R, Flynn JP, Regan J, Crain CR, Moser C, Hughes MD, Ritz J, Ribeiro RM, Ke R, Dragavon JA, Javan AC, Nirula A, Klekotka P, Greninger AL, Fletcher CV, Daar ES, Wohl DA, Eron JJ, Currier JS, Parikh UM, Sieg SF, Perelson AS, Coombs RW, Smith DM, Li JZ; ACTIV-2/A5401 Study Team. Emergence of SARS-CoV-2 escape mutations during Bamlanivimab therapy in a phase II randomized clinical trial. Nat Microbiol. 2022 Nov;7(11):1906-1917. doi: 10.1038/s41564-022-01254-1. Epub 2022 Oct 26.

    PubMed 36289399

  • Moser C, Li JZ, Eron JJ, Aga E, Daar ES, Wohl DA, Coombs RW, Javan AC, Bender Ignacio RA, Jagannathan P, Ritz J, Sieg SF, Parikh UM, Hughes MD, Currier JS, Smith DM, Chew KW; ACTIV-2/A5401 Study Team. Predictors of SARS-CoV-2 RNA From Nasopharyngeal Swabs and Concordance With Other Compartments in Nonhospitalized Adults With Mild to Moderate COVID-19. Open Forum Infect Dis. 2022 Nov 11;9(11):ofac618. doi: 10.1093/ofid/ofac618. eCollection 2022 Nov.

    PubMed 36467293

  • Ramirez SI, Grifoni A, Weiskopf D, Parikh UM, Heaps A, Faraji F, Sieg SF, Ritz J, Moser C, Eron JJ, Currier JS, Klekotka P, Sette A, Wohl DA, Daar ES, Hughes MD, Chew KW, Smith DM, Crotty S; Accelerating COVID-19 Therapeutic Interventions and Vaccines-2/A5401 (ACTIV-2/A5401) Study Team. Bamlanivimab therapy for acute COVID-19 does not blunt SARS-CoV-2-specific memory T cell responses. JCI Insight. 2022 Dec 22;7(24):e163471. doi: 10.1172/jci.insight.163471.

    PubMed 36378539

  • Jilg N, Chew KW, Giganti MJ, Daar ES, Wohl DA, Javan AC, Kantor A, Moser C, Coombs RW, Neytman G, Hoover K, Jana A, Hart PA, Greninger AL, Szurgot B, Eron JJ, Currier JS, Hughes MD, Smith DM, Li JZ; ACTIV-2/A5401 Study Team. One Week of Oral Camostat Versus Placebo in Nonhospitalized Adults With Mild-to-Moderate Coronavirus Disease 2019: A Randomized Controlled Phase 2 Trial. Clin Infect Dis. 2023 Oct 5;77(7):941-949. doi: 10.1093/cid/ciad342.

    PubMed 37279602

  • Taiwo BO, Chew KW, Moser C, Wohl DA, Daar ES, Li JZ, Greninger AL, Bausch C, Luke T, Hoover K, Neytman G, Giganti MJ, Olefsky M, Javan AC, Fletcher CV, Eron JJ, Currier JS, Hughes MD, Smith DM; ACTIV-2/A5401 Study Team. Phase 2 Safety and Antiviral Activity of SAB-185, a Novel Polyclonal Antibody Therapy for Nonhospitalized Adults With COVID-19. J Infect Dis. 2023 Jul 14;228(2):133-142. doi: 10.1093/infdis/jiad013.

    PubMed 36661240

  • Evering TH, Chew KW, Giganti MJ, Moser C, Pinilla M, Wohl DA, Currier JS, Eron JJ, Javan AC, Bender Ignacio R, Margolis D, Zhu Q, Ma J, Zhong L, Yan L, D'Andrea Nores U, Hoover K, Mocherla B, Choudhary MC, Deo R, Ritz J, Fischer WA, Fletcher CV, Li JZ, Hughes MD, Smith D, Daar ES; ACTIV-2/A5401 Study Team. Safety and Efficacy of Combination SARS-CoV-2 Neutralizing Monoclonal Antibodies Amubarvimab Plus Romlusevimab in Nonhospitalized Patients With COVID-19. Ann Intern Med. 2023 May;176(5):658-666. doi: 10.7326/M22-3428. Epub 2023 Apr 18.

    PubMed 37068272

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing bamlanivimab 7000mg, BRII-196+BRII-198 and AZD7442 (IV) in people with Coronavirus and Covid19, run by National Institute of Allergy and Infectious Diseases (NIAID) at 252 sites in 9 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 45 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 252 sites in United States, South Africa, Brazil, Mexico, Argentina and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Jul 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

COVID-19 Symptom Duration (Phase 2) (time frame: Up to Day 28). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04518410, which also lists 45 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2024.

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