Evaluation of Protease Inhibition for COVID-19 in Standard-Risk Patients (EPIC-SR).

Stopped early · Phase 2/Phase 3 · Has a placebo group

Conditions studied: COVID-19

In brief

The primary hypothesis to be tested is whether or not there is a difference in time to sustained alleviation of all targeted COVID-19 signs and symptoms through Day 28 between PF-07321332/ritonavir and placebo.

Key facts

Study ID

NCT05011513

Run by

Pfizer

People needed

1440

Starts

2021-08-25

Expected to finish

2022-07-25

Last updated by the study team

2023-08-14

Who can join

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

You may qualify if…

• Confirmed SARS-CoV-2 infection 5 days prior to randomization
• Initial onset of COVID-19 signs/symptoms within 5 days of randomization
• Fertile participants must agree to use a highly effective method of contraception

You may not qualify if…

• Has at least one underlying medical condition associated with an increased risk of developing severe illness from COVID-19
• History of or need for hospitalization for the medical treatment of COVID-19
• Prior diagnosis of SARS-CoV-2 infection (reinfection)
• Known medical history of liver disease
• Receiving dialysis or have known renal impairment
• Known Human Immunodeficiency Virus (HIV) infection with viral load > 400 copies/ml or taking prohibited medications for HIV treatment
• Suspected or confirmed concurrent active systemic infection other than COVID-19
• Current or expected use of any medications or substances that are highly dependent on Cytochrome P450 3A4 (CYP3A4) for clearance or are strong inducers of CYP3A4
• Has received or is expected to receive monoclonal antibody treatment or convalescent COVID-19 plasma
• Has received any SARS-CoV-2 vaccine within 12 months of screening
• Participating in another interventional clinical study with an investigational compound or device, including those for COVID-19
• Known prior participation in this trial or other trial involving PF-07321332
• Oxygen saturation of < 92% on room air
• Females who are pregnant or breastfeeding

Where it is running

• Cahaba Research Inc — Pelham, Alabama, United States
• The Institute for Liver Health dba Arizona Clinical Trials — Mesa, Arizona, United States
• Matrix Mobile Health Clinic #49, #35, and #62 — Scottsdale, Arizona, United States
• The Institute for Liver Health dba Arizona Clinical Trials — Tucson, Arizona, United States
• Hope Clinical Research — Canoga Park, California, United States
• Lightship — El Segundo, 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
• South Bay Clinical Research Institute — Redondo Beach, California, United States
• Benchmark Research — Sacramento, California, United States
• Optimus Medical Group — San Francisco, California, United States
• Hope Clinical Research (COVID Satellite Site) — West Hills, California, United States
• Future Innovative Treatments, LLC — Colorado Springs, Colorado, United States
• Synergy Healthcare — Bradenton, Florida, United States
• TrueBlue Clinical Research — Brandon, 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
• Omega Research Orlando, LLC — DeBary, 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
• Unlimited Medical Research Group, LLC — Hialeah Gardens, Florida, United States
• MOORE Clinical Research, Inc. — Brandon, Florida, United States

Full record on ClinicalTrials.gov

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