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A PHASE 2/3, RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY, PLACEBO CONTROLLED STUDY TO EVALUATE THE SAFETY AND EFFICACY OF 2 REGIMENS OF ORALLY ADMINISTERED PF-07321332/RITONAVIR IN PREVENTING SYMPTOMATIC SARS-COV-2 INFECTION IN ADULT HOUSEHOLD CONTACTS OF INDIVIDUALS WITH SARS-COV-2 INFECTION

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A PHASE 2/3, RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY, PLACEBO CONTROLLED STUDY TO EVALUATE THE SAFETY AND EFFICACY OF 2 REGIMENS OF ORALLY ADMINISTERED PF-07321332/RITONAVIR IN PREVENTING SYMPTOMATIC SARS-COV-2 INFECTION IN ADULT HOUSEHOLD CONTACTS OF INDIVIDUALS WITH SARS-COV-2 INFECTION

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 24 Jul 2024

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At a glance

  • Drugs Nirmatrelvir+ritonavir (Primary)
  • Indications SARS-CoV-2 acute respiratory disease
  • Focus Registrational; Therapeutic Use
  • Acronyms EPIC-PEP
  • Sponsors Pfizer

    • Most Recent Events

    • 16 Mar 2023 According to a Pfizer media release, the target Prescription Drug User Fee Act (PDUFA) action date for a decision by the FDA is May 2023
    • 16 Mar 2023 According to a Pfizer media release, the U.S. Food and Drug Administration's (FDA) Antimicrobial Drugs Advisory Committee (AMDAC) voted 16 to 1 that available data support the safety and effectiveness of PAXLOVID (nirmatrelvir tablets and ritonavir tablets) for the treatment of mild-to-moderate COVID-19. The AMDAC based its vote on the totality of scientific and real-world evidence shared by Pfizer, including safety and efficacy data from the EPIC clinical development program.
    • 06 Jul 2022 Status changed from recruiting to completed.

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