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AN INTERVENTIONAL EFFICACY AND SAFETY, PHASE 2/3, DOUBLE-BLIND, 2 ARM STUDY TO INVESTIGATE ORALLY ADMINISTERED PF 07321332/RITONAVIR COMPARED WITH PLACEBO IN NONHOSPITALIZED SYMPTOMATIC ADULT PARTICIPANTS WITH COVID-19 WHO ARE AT LOW RISK OF PROGRESSING TO SEVERE ILLNESS

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AN INTERVENTIONAL EFFICACY AND SAFETY, PHASE 2/3, DOUBLE-BLIND, 2 ARM STUDY TO INVESTIGATE ORALLY ADMINISTERED PF 07321332/RITONAVIR COMPARED WITH PLACEBO IN NONHOSPITALIZED SYMPTOMATIC ADULT PARTICIPANTS WITH COVID-19 WHO ARE AT LOW RISK OF PROGRESSING TO SEVERE ILLNESS

Status: Discontinued
Phase of Trial: Phase II/III

Latest Information Update: 27 Dec 2023

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At a glance

  • Drugs Nirmatrelvir+ritonavir (Primary) ; Ritonavir (Primary)
  • Indications COVID 2019 infections
  • Focus Registrational; Therapeutic Use
  • Acronyms EPIC-SR
  • Sponsors Pfizer

    • Most Recent Events

    • 22 Dec 2023 Results of viral RNA shedding data from two phase 2/3 trials EPIC-HR & EPIC-SR assessing the role of nirmatrelvir/ritonavir treatment in COVID-19 rebound published in the Morbidity and Mortality Weekly Report.
    • 30 Nov 2023 This trial has been completed in Spain (End Date: 25 Jul 2022), according to European Clinical Trials Database record.
    • 25 May 2023 According to a Pfizer media release, based on the data from this study the company received the U.S. Food and Drug Administration's (FDA) approval for PAXLOVID™ (nirmatrelvir tablets and ritonavir tablets) for the treatment of mild-to-moderate COVID-19 in adults who are at high risk for progression to severe COVID-19, including hospitalization or death
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