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

Completed · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Coronavirus, Covid19

In brief

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.

Key facts

Study ID

NCT04518410

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

4044

Starts

2020-08-19

Expected to finish

2023-06-20

Last updated by the study team

2024-08-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• North Alabama Research Center LLC (Site 1194), 721 W. Market St., Ste. B — Athens, Alabama, United States
• University of Alabama at Birmingham (Site 1005), 908 20th Street South — Birmingham, Alabama, United States
• Cullman Clinical Trials (Site 1140), 501 Clark St. NE. — Cullman, Alabama, United States
• Jasper Summit Research, LLC. (Site 1056), 1280 Summit — Jasper, Alabama, United States
• Absolute Clinical Research, LLC. (Site 1186), 7725 North 43rd Avenue, Ste. 211 — Phoenix, Arizona, United States
• University of Arizona (Site 1043), 1501 N. Campbell Ave., Rm. 6410 — Tucson, Arizona, United States
• Omnibus Clinical Research (Site 1253), 3340 W. Ball Road, Ste. I — Anaheim, California, United States
• Franco A. Felizarta MD (Site 1174), 3535 San Dimas St. — Bakersfield, California, United States
• Clearview Medical Research LLC. (Site 1251), 2714 Hidaway Ave., Ste. 103 — Canyon Country, California, United States
• St. Jude Heritage Medical Group (Site 1093), 2151 N. Harbor Blvd. — Fullerton, California, United States
• University of California San Diego (Site 1160), 9350 Campus Point Drive, Perlman Cancer Cancer — La Jolla, California, United States
• Fadi A. Haddad, MD, Inc. (Site 1146), 8860 Center Dr., Ste. 320 — La Mesa, California, United States
• Atella Clinical Research (Site 1111), 5451 La Palma Avenue — La Palma, California, United States
• Loma Linda University Health (Site 1110), 11374 Mountain View, Dover Bldg, Ste. C — Loma Linda, California, United States
• University of Southern California (Site 1057), 1300 N. Mission Rd., Rm 349 — Los Angeles, California, United States
• UCLA CARE Center (Site 1003), 11075 Santa Monica Blvd., Suite 100 — Los Angeles, California, United States
• Science 37, Inc. (Site 1124), 12121 Bluff Creek Dr., Ste. 100 — Los Angeles, California, United States
• VA Northern California Health Care System (NAVREF) (Site 1137), 10535 Hospital Way — Mather, California, United States
• Central Valley Research, LLC (Site 1085), 400 E. Orangeburg Ave., Ste. 5 — Modesto, California, United States
• Hoag Memorial Hospital Presbyterian (Site 1200), 1 Hoag Dr. — Newport Beach, California, United States
• Valley Clinical Research, Inc. (Site 1059), 18433 Roscoe Blvd., Ste 210 — Northridge, California, United States
• University of California Irvine (Site 1083), 843 Health Sciences Road — Orange, California, United States
• FOMAT Medical Research (Site 1136), 300 South A Street — Oxnard, California, United States
• Eisenhower Medical Center (Site 1040), 39000 Bob Hope Drive — Rancho Mirage, California, United States
• Pinnacle Research Group (Site 1082), 321 E. 10th Street — Anniston, Alabama, United States

Full record on ClinicalTrials.gov

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