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

Pfizer

Status and phase: Terminated; Phase 3; Phase 2

Conditions: COVID-19

Treatments: Drug: Placebo; Drug: Ritonavir; Drug: PF-07321332

Study type: Interventional

Funder types: Industry

Identifiers

NCT05011513

C4671002

EPIC-SR (Other Identifier)

2021-002857-28 (EudraCT Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,440 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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
• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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1,440 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

Drug: Placebo