A Study of PF-07321332/Ritonavir in Non-hospitalized Low-Risk Adult Participants With COVID-19

• Status: Recruiting
• Trial end date: 2022-02-28
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer
• Treatments: Ritonavir

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 received or is expected to receive any COVID-19 vaccine, except for participants with an underlying medical condition associated with an increased risk of developing severe illness from COVID-19. Participants with these conditions who are fully vaccinated are considered to be at lower risk of developing severe disease and are therefore considered eligible.

• 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

• Is expected to receive a SARS-CoV-2 vaccine between screening and the study Day 34 visit

• 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