EPIC-HR: Study of Oral PF-07321332/Ritonavir Compared With Placebo in Nonhospitalized High Risk Adults With COVID-19

Pfizer logo

Pfizer

Status and phase

Completed
Phase 3
Phase 2

Conditions

COVID-19

Treatments

Drug: Placebo
Drug: PF-07321332
Drug: Ritonavir

Study type

Interventional

Funder types

Industry

Identifiers

NCT04960202
C4671005
2021-002895-38 (EudraCT Number)
EPIC-HR (Other Identifier)

Details and patient eligibility

About

The purpose of this study is to determine whether PF-07321332/ritonavir is safe and effective for the treatment of adults who are ill with COVID-19 and do not need to be in the hospital, but are at an increased risk of developing severe illness. Throughout the study period, provision will be made to allow study visits to be conducted at a participant's home or another non-clinic location if available. The total study duration is up to 24 weeks.

Enrollment

2,246 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Confirmed SARS-CoV-2 infection within 5 days prior to randomization
  • Initial onset of COVID-19 signs/symptoms within 5 days prior to the day of randomization and at least 1 of the specified COVID-19 signs/symptoms present on the day of randomization
  • Fertile participants must agree to use a highly effective method of contraception
  • Has at least 1 characteristic or underlying medical condition associated with an increased risk of developing severe illness from COVID-19

Exclusion criteria

  • History of or need for hospitalization for the medical treatment of COVID-19
  • Prior to current disease episode, any confirmed SARS-CoV-2 infection
  • Known medical history of active liver disease
  • Receiving dialysis or have known moderate to severe renal impairment
  • Known human immunodeficiency virus (HIV) infection with a viral load greater than 400 copies/mL or taking prohibited medications for HIV treatment
  • Suspected or confirmed concurrent active systemic infection other than COVID-19
  • History of hypersensitivity or other contraindication to any of the components of the study intervention
  • Current or expected use of any medications or substances that are highly dependent on CYP3A4 for clearance or are strong inducers of CYP3A4
  • Has received or is expected to receive convalescent COVID-19 plasma
  • Has received or is expected to receive any dose of a SARS-CoV-2 vaccine before the Day 34 visit
  • Participating in another interventional clinical study with an investigational compound or device, including those for COVID-19 through the long-term follow-up visit
  • Known prior participation in this trial or other trial involving PF-07321332
  • Oxygen saturation of <92% on room air, or on their standard home oxygen supplementation for those who regularly receive chronic supplementary oxygen for an underlying lung condition
  • Females who are pregnant or breastfeeding

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

2,246 participants in 2 patient groups, including a placebo group

PF-07321332/ritonavir
Experimental group
Description:
Orally administered PF-07321332+ritonavir
Treatment:
Drug: Ritonavir
Drug: PF-07321332
Placebo
Placebo Comparator group
Description:
Orally administered placebo
Treatment:
Drug: Placebo

Trial documents
2

Trial contacts and locations

201

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Data sourced from clinicaltrials.gov

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