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

Completed · Phase 2/Phase 3 · Has a placebo group

Conditions studied: COVID-19

In brief

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.

Key facts

Study ID

NCT04960202

Run by

Pfizer

People needed

2091

Starts

2021-07-16

Expected to finish

2022-04-25

Last updated by the study team

2025-07-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• The Institute for Liver Health dba Arizona Clinical Trials — Mesa, Arizona, United States
• The Institute for Liver Health dba Arizona Clinical Trials — Tucson, Arizona, United States
• Hope Clinical Research — Canoga Park, California, United States
• Ascada Research — Fullerton, California, United States
• Atella Clinical Research LLC. — La Palma, California, United States
• Ark Clinical Research — Long Beach, California, United States
• American Institute of Research — Los Angeles, California, United States
• South Bay Clinical Research Institute — Redondo Beach, California, United States
• Hope Clinical Research (COVID Satellite Site) — West Hills, California, United States
• Future Innovative Treatments, LLC — Colorado Springs, Colorado, United States
• Xera Med Research — Boca Raton, Florida, United States
• MOORE Clinical Research, Inc. — Brandon, Florida, United States
• Innovative Research of West Florida, Inc. — Clearwater, Florida, United States
• Herco Medical and Research Center Inc — Coral Gables, Florida, United States
• Advance Clinical Research Group — Cutler Bay, Florida, United States
• Beautiful Minds Clinical Research Center — Cutler Bay, Florida, United States
• Qway Research — Hialeah, Florida, United States
• Eastern Research Inc — Hialeah, Florida, United States
• Inpatient Research Clinic — Hialeah, Florida, United States
• Doral Medical Research LLC. — Hialeah, Florida, United States
• Doral Medical Research,LLC — Hialeah, Florida, United States
• Unlimited Medical Research Group, LLC — Hialeah Gardens, Florida, United States
• Advanced Pulmonary Research Institute — Loxahatchee Groves, Florida, United States
• Angels Clinical Research Institute — Miami, Florida, United States
• Cahaba Research Inc — Pelham, Alabama, United States

Full record on ClinicalTrials.gov

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