Principal Investigator
Enrollment Status
Clinical Trial ID
Clinical Trial 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
Funding Agency/Sponsor
Industry
Disease
Other
Enrollment Eligibility
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