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

TerminatedPhase 2, Phase 3

Sponsor: Pfizer

Conditions: COVID-19

Interventions: PF-07321332, Ritonavir, Placebo, Placebo

Countries: United States, Argentina, Brazil, Bulgaria, Colombia, Czechia, Hungary, Japan

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Locations (225)

Pelham, Alabama, United States
Mesa, Arizona, United States
Scottsdale, Arizona, United States
Tucson, Arizona, United States
Canoga Park, California, United States
El Segundo, California, United States
Fullerton, California, United States
La Palma, California, United States
Long Beach, California, United States
Redondo Beach, California, United States
Sacramento, California, United States
San Francisco, California, United States
West Hills, California, United States
Colorado Springs, Colorado, United States
Bradenton, Florida, United States
Brandon, Florida, United States
Brandon, Florida, United States
Coral Gables, Florida, United States
Cutler Bay, Florida, United States
Cutler Bay, Florida, United States
DeBary, Florida, United States
Hialeah, Florida, United States
Hialeah, Florida, United States
Hialeah, Florida, United States
Hialeah Gardens, Florida, United States
Lutz, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
+ 195 more on CT.gov