PF-07304814 for Inpatients With COVID-19 (An ACTIV-3/TICO Treatment Trial)
Condition: COVID-19
MeSH terms: COVID-19
Intervention: PF-07304814; Placebo; Remdesivir
Intervention description: PF-07304814 is a phosphate ester prodrug of PF-00835231 (active moiety), a potent and selective inhibitor of the SARS-CoV-2 3CLpro.; Commercially available 0.9% sodium chloride solution; Antiviral agent
Intervention MeSH terms: Remdesivir
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 58.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: COVID-19; COVID 19; Coronaviridae Infections; Coronavirus Infections; RNA Virus Infections; Virus Diseases; Nidovirales Infections; SARS-CoV-2; SARS Coronavirus; ACTIV-3; ACTIV3; TICO

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.
    

Eligibility 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.