First-In-Human Study To Evaluate Safety, Tolerability, And Pharmacokinetics of PF-07304814 In Hospitalized Participants With COVID-19.
Study Type/Phase: 1b
The purpose of this study is to evaluate the safety, effectiveness, and dosing of an investigational drug called PF-07304814 for SARS-CoV-2 infection. This is a Phase 1 trial that will occur in two parts. A Phase 1 trial is the first time the investigational drug will be used in humans and there is no evidence it is effective in treating SARS-CoV-2. During Part 1 of this study, subjects will be administered the drug intravenously over a period of 24 hours to determine an appropriate dosing of the drug. This will be followed by Part 2, an extended infusion, where the drug will be administered intravenously over 5 days based on the determined dosage in Part 1.
There remains an urgent need for additional safe and effective therapeutic interventions for COVID-19 that shortens time to clinical recovery and prevents the progression of infection to more serious disease and death. The function of PF-07304814 is to inhibit the activity of an enzyme (SARS 3CL protease) that is essential in the life cycle of SARS-CoV-2, thus preventing viral replication. This drug has not been approved by the U.S. Food and Drug Administration (FDA) for the treatment of COVID-19. Subjects will be followed for at least 28 days post treatment. Participants may be asked to provide biological samples including blood, urine, nasal, and saliva swabs for study analysis which may provide a greater understanding of the study intervention.
Speak with your doctor to determine whether you meet the following criteria for participation in this study.
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For more information about this clinical trial, including trial status, eligibility and full trial listing, visit www.clinicaltrials.gov.