ACTIV-3: Therapeutics for Inpatients With COVID-19

Completed · Phase 3 · Has a placebo group

Conditions studied: Covid19

In brief

This study looks at the safety and effectiveness of different drugs in treating COVID-19 in people who have been hospitalized with the infection. Participants in the study will be treated with either a study drug plus current standard of care (SOC), or with placebo plus current SOC.

Key facts

Study ID

NCT04501978

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

2753

Starts

2020-08-04

Expected to finish

2023-07-14

Last updated by the study team

2023-08-25

Who can join

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

You may qualify if…

• Signed informed consent.
• Positive test for COVID-19 and progressive disease suggestive of ongoing COVID-19 infection.
• Symptoms of COVID-19 for ≤ 12 days.
• Require admission to hospital for acute medical care (not for purely public health or quarantine purposes).

You may not qualify if…

• Patients who have received plasma from a person who recovered from COVID-19 or who have received neutralizing monoclonal antibodies at any time prior to hospitalization.
• Patients not willing to abstain from participation in other COVID-19 treatment trials until after Day 5 of the study. Co-enrollment in certain trials that compare recommended Standard of Care treatments may be allowed, based on the opinion of the study leadership team.
• Any condition which, in the opinion of the responsible investigator, participation would not be in the best interest of the participant or that could prevent, limit, or confound the protocol-specified assessments.
• Patients considered unable to participate in study procedures.
• Women of child-bearing potential who are not already pregnant at study entry and who are unwilling to acknowledge strong advice to abstain from sexual intercourse with men or practice appropriate contraception through 18 months of the study.
• Women of child-bearing potential who are unwilling to acknowledge the strong advice to abstain from sexual intercourse with men or practice appropriate contraception through 5 weeks of the study (PF-07304814 investigational agent).
• Pregnant women (PF-07304814 investigational agents).
• Nursing mothers (PF-07304814 investigational agents).
• Men who are unwilling to acknowledge the strong advice to abstain from sexual intercourse with women of child-bearing potential or to use barrier contraception through 18 months of the study.
• Men who are unwilling to acknowledge the strong advice to abstain from sexual intercourse with women of child-bearing potential or to use barrier contraception through 5 weeks of the study (PF-07304814 investigational agent).
• Presence at study enrollment of any of the following:
• stroke
• meningitis
• encephalitis
• myelitis
• myocardial ischemia
• myocarditis
• pericarditis
• symptomatic congestive heart failure
• arterial or deep venous thrombosis or pulmonary embolism
• Current or imminent requirement for any of the following:
• invasive mechanical ventilation
• ECMO (extracorporeal membrane oxygenation)
• Mechanical circulatory support
• vasopressor therapy

Where it is running

• Southern Arizona VA Healthcare System (Site 074-009), 3601 S. 6th Ave. — Tucson, Arizona, United States
• Velocity Chula Vista (Site 080-034), 752 Medical Center Ct., Ste. 304 — Chula Vista, California, United States
• Community Regional Medical Center (Site 203-005), 2823 Fresno Street — Fresno, California, United States
• Velocity San Diego (Site 080-035), 5565 Grossmont Center Drive, Building 2, Suite 1 — La Mesa, California, United States
• VA Loma Linda Healthcare System (Site 074-017), 11201 Benton Street — Loma Linda, California, United States
• VA Long Beach Healthcare System (Site 074-026), 5901 East 7th Street (09/151-M2) — Long Beach, California, United States
• Keck Hospital of USC (Site 301-020), 1500 San Pablo Street — Los Angeles, California, United States
• Cedars-Sinai Medical Center (Site 208-002), 8700 Beverly Blvd. — Los Angeles, California, United States
• Ronald Reagan UCLA Medical Center (Site 203-002), 757 Westwood Plaza — Los Angeles, California, United States
• Sacramento VA Medical Center (Site 074-023), 10535 Hospital Way — Mather, California, United States
• Hoag Memorial Hospital Presbyterian (Site 080-026), One Hoag Drive — Newport Beach, California, United States
• Palo Alto VAMC (Site 074-005), 3801 Miranda Avenue — Palo Alto, California, United States
• UC Davis Health (Site 203-004), 2315 Stockton Blvd. — Sacramento, California, United States
• VA San Diego Healthcare System (Site 074-016), 3350 La Jolla Village Drive — San Diego, California, United States
• UCSF Medical Center at Mount Zion (Site 203-007), 1600 Divisadero St. — San Francisco, California, United States
• San Francisco VAMC (Site 074-002), 4150 Clement St. — San Francisco, California, United States
• UCSF Medical Center (Site 203-001), Moffitt-Long Hospital, 505 Parnassus Ave. — San Francisco, California, United States
• Stanford University Hospital & Clinics (Site 203-003), 300 Pasteur Dr. — Stanford, California, United States
• Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center (Site 066-002), 1124 W. Carson Street, CDCRC Building — Torrance, California, United States
• University of Colorado Hospital (Site 204-001), 12605 E. 16th Avenue — Aurora, Colorado, United States
• Denver Public Health (Site 017-004), 660 Bannock St., MC2600 (Infectious Disease Clinic) — Denver, Colorado, United States
• National Jewish Health / St. Joseph Hospital (Site 204-003), 1400 Jackson Street — Denver, Colorado, United States
• West Haven VA Medical Center (Site 025-007), 950 Campbell Avenue — West Haven, Connecticut, United States
• MedStar Georgetown University Hospital (Site 067-001), 3800 Reservoir Road NW — Washington D.C., District of Columbia, United States
• Banner University Medical Center Tucson (Site 206-004), 1625 N. Campbell Avenue — Tucson, Arizona, United States

Full record on ClinicalTrials.gov

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