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Evaluation of Protease Inhibition for COVID-19 in Standard-Risk Patients (EPIC-SR). | Clinical Trials | Clareo Health

TERMINATEDPHASE2/PHASE3

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

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

NCT05011513•Pfizer

View on ClinicalTrials.gov

Summary

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.

Detailed Description

Throughout the study period, provision will be made to allow study visits to be conducted at a participant's home or at another non-clinic location, if available. The total study duration is up to 24 weeks.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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
+4 more criteria

Locations (225)

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

Key Dates

Start Date

August 25, 2021

Primary Completion Date

July 25, 2022

Completion Date

July 25, 2022

Last Updated

August 14, 2023

Enrollment

1,440

ACTUAL participants

Conditions

COVID-19

Interventions

PF-07321332

DRUG

Ritonavir

DRUG

Placebo

DRUG

Placebo

DRUG

Improving Post COVID-19 Syndrome With Hyperbaric Oxygen Treatments

NCT06082518

Post COVID-19 ConditionPost-COVID-19 Syndrome+4 more

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RECRUITINGPHASE1

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 14, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Improving Post COVID-19 Syndrome With Hyperbaric Oxygen Treatments

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