PF-07304814 for Inpatients With COVID-19 (An ACTIV-3/TICO Treatment Trial)
COVID-19
About this trial
This is an interventional treatment trial for COVID-19 focused on measuring COVID-19, COVID 19, Coronaviridae Infections, Coronavirus Infections, RNA Virus Infections, Virus Diseases, Nidovirales Infections, SARS-CoV-2, SARS Coronavirus, ACTIV-3, ACTIV3, TICO
Eligibility Criteria
Inclusion Criteria: Refer to the master protocol (NCT04501978) Exclusion Criteria: Refer to the master protocol (NCT04501978) Additional Exclusion Criteria: Participants with moderate to severe hepatic impairment (i.e. Child-Pugh class B or C) or acute liver failure. Participants receiving any medications or substances that are strong inhibitors or inducers of cytochrome P450 (CYP) 3A4 (see Section H6.3.4). Patients will be excluded if taking drugs which have a narrow therapeutic window that are substrates of CYP3A4, including but not limited to: astemizole, cisapride, cyclosporine, dihydroergotamine, ergotamine, pimozide, quinidine, sirolimus, tacrolimus, and terfenadine. Pregnant women Nursing mothers 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. 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. Patients with a history of deep vein thrombosis or pulmonary thrombotic embolism*. Prior to the initial futility assessment which is performed when approximately 150 patients have been enrolled on PF-07304814 and 150 on placebo, patients with a history of deep vein thrombosis or pulmonary embolism will be excluded. These patients will be eligible for the trial if the initial futility assessment is passed by this agent, and if risk-benefit is favorable based on an assessment of available data that is reviewed by the independent DSMB. These data will include treatment comparisons of thromboembolic events and coagulation markers, and any additional data from studies carried out by Pfizer.
Sites / Locations
- Velocity Chula Vista (Site 080-034), 752 Medical Center Ct., Ste. 304
- Cedars-Sinai Medical Center (Site 208-002), 8700 Beverly Blvd.
- Sacramento VA Medical Center (Site 074-023), 10535 Hospital Way
- Hoag Memorial Hospital Presbyterian (Site 080-026), One Hoag Drive
- Palo Alto VAMC (Site 074-005), 3801 Miranda Avenue
- UC Davis Health (Site 203-004), 2315 Stockton Blvd.
- VA San Diego Healthcare System (Site 074-016), 3350 La Jolla Village Drive
- San Francisco VAMC (Site 074-002), 4150 Clement St.
- National Jewish Health / St. Joseph Hospital (Site 204-003), 1400 Jackson Street
- West Haven VA Medical Center (Site 025-007), 950 Campbell Avenue
- MedStar Health Research Institute (Site 009-021), MedStar Washington Hospital Center, 110 Irving St., NW.
- Bay Pines VAMC (Site 074-004), 10000 Bay Pines Blvd., Bldg. 100, Room 5B-104
- Hillsborough County Health Department, University of South Florida (Site 032-001)
- Lutheran Medical Group (Site 301-010), 7916 W. Jefferson Boulevard
- Ochsner Clinic Foundation (Site 301-015), 1514 Jefferson Highway
- Massachusetts General Hospital (Site 202-002), 55 Fruit Street
- Beth Israel Deaconess Medical Center (Site 202-001), 330 Brookline Ave.
- Henry Ford Health System, Henry Ford Hospital (Site 014-001), 2799 W. Grand Blvd.
- Dartmouth-Hitchcock Medical Center/Mary Hitchcock Memorial Hospital (Site 301-024), One Medical Center Drive
- Duke University Hospital (Site 301-006), 2301 Erwin Road
- Portland VA Healthcare System (Site 074-024), 3710 SW. US Veterans Hospital Road
- Rhode Island Hospital (Site 080-036), 593 Eddy Street
- The Miriam Hospital (Site 080-039), 164 Summit Ave.
- Ralph H. Johnson VA Medical Center (Site 074-015), 109 Bee Street
- MUSC Research Nexus Clinic (Site 210-002), 96 Jonathan Lucas St., CSB 214
- MUSC Health Florence Medical Center (Site 210-006), 805 Pamplico Highway
- Parkland Health and Hospital Systems (Site 084-002), 5200 Harry Hines Blvd
- UT Southwestern Medical Center (Site 084-001), 1936 Amelia Court, 2nd Floor
- Baylor, Scott and White Health (Site 301-003), Baylor University Medical Center, 3500 Gaston Ave.
- University of Utah Hospital (Site 211-002), 419 Wakara Way, Suite 207
- West Virginia University (Site 301-023), One Medical Center Drive
- Aalborg Hospital (Site 625-005), Hobrovej 18
- Aarhus Universitetshospital, Skejby (Site 625-002), Department of Infectious Diseases, Palle Juul-Hensens Boulevard 99
- Righospitalet (Site 625-006), Blegdamsvej 9,
- Bispebjerg Hospital (Site 625-013), Bispebjerg Bakke 23
- Herlev/Gentofte Hospital (Site 625-012), Medicinsk Afdeling, Herlev Ringvej 75
- Nordsjællands Hospital (Site 625-009), Dyrehavevej 29
- Kolding Sygehus (Site 625-011), Medicinsk Afdeling, Sygehusvej 24
- Odense University Hospital (Site 625-004), Infektionsmedicinsk Forskningsenhed, J.B. Winsløwsgade 4
- Zealand University Hospital, Roskilde (Site 625-010), Sygehusvej 10
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
PF-07304814 plus SOC
Placebo plus SOC
PF-07304814 250 mg per day for 5 days; administered as a constant rate IV infusion Remdesivir is provided to all study participants as SOC unless contraindicated for an individual patient; administered by IV infusion
Placebo administered by IV infusion Remdesivir is provided to all study participants as SOC unless contraindicated for an individual patient; administered by IV infusion