PF-07304814 for Inpatients With COVID-19 (An ACTIV-3/TICO Treatment Trial)

• Status: Suspended
• Trial end date: 2023-06-30
• Target enrollment: 0
• Participant gender: All

Summary

This study looks at the safety and effectiveness of PF-07304814 in treating COVID-19 in people who have been hospitalized with the infection. Participants in the study will be treated with either PF-07304814 plus current standard of care (SOC), or with placebo plus current SOC. This is ACTIV-3/TICO Treatment Trial H6.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Minnesota
• Collaborators: AIDS Clinical Trials Group; Cardiothoracic Surgical Trials Network (CTSN); International Network for Strategic Initiatives in Global HIV Trials (INSIGHT); Kirby Institute; Medical Research Council; National Heart, Lung, and Blood Institute (NHLBI); Pfizer; Prevention and Early Treatment of Acute Lung Injury (PETAL); University of Copenhagen; US Department of Veterans Affairs; Washington D.C. Veterans Affairs Medical Center
• Treatments: Remdesivir

Criteria

Inclusion Criteria: Refer to the master protocol (NCT04501978)

Exclusion Criteria: Refer to the master protocol (NCT04501978)

Additional Exclusion Criteria:

1. Participants with moderate to severe hepatic impairment (i.e. Child-Pugh class B or C) or acute liver failure.

2. Participants receiving any medications or substances that are strong inhibitors or inducers of cytochrome P450 (CYP) 3A4 (see Section H6.3.4).

3. 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.

4. Pregnant women

5. Nursing mothers

6. 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.

7. 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.

8. 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.