COVID-19
Conditions
Interventions
PF-07321332 (tablet)/Ritonavir (capsule) or placebo (tablet or capsule) every 12 hours for 5 days (10 doses total)
Sponsors
Kawai Norisuke
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: *Confirmed SARS-CoV-2 infection within 5 days prior to randomization *Initial onset of COVID-19 signs/symptoms within 5 days prior to the day of randomization and at least 1 of the specified COVID-19 signs/symptoms present on the day of randomization *Fertile participants must agree to use a highly effective method of contraception *Has at least 1 characteristic or underlying medical condition associated with an increased risk of developing severe illness from COVID-19
Exclusion criteria
Exclusion criteria: *History of or need for hospitalization for the medical treatment of COVID-19 *Prior to current disease episode, any confirmed SARS-CoV-2 infection *Known medical history of active liver disease *Receiving dialysis or have known moderate to severe renal impairment *Known human immunodeficiency virus (HIV) infection with a viral load greater than 400 copies/mL or taking prohibited medications for HIV treatment *Suspected or confirmed concurrent active systemic infection other than COVID-19 *History of hypersensitivity or other contraindication to any of the components of the study intervention *Current or expected use of any medications or substances that are highly dependent on CYP3A4 for clearance or are strong inducers of CYP3A4 *Has received or is expected to receive convalescent COVID-19 plasma *Has received or is expected to receive any dose of a SARS-CoV-2 vaccine before the Day 34 visit *Participating in another interventional clinical study with an investigational compound or device, including those for COVID-19 through the long-term follow-up visit *Known prior participation in this trial or other trial involving PF-07321332 *Oxygen saturation of <92% on room air, or on their standard home oxygen supplementation for those who regularly receive chronic supplementary oxygen for an underlying lung condition *Females who are pregnant or breastfeeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of participants with COVID-19 related hospitalization or death from any cause [ Time Frame: Day 1 through Day 28 ] | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)of PF-07321332/ritonavir relative to placebo [ Time Frame: Day 1 through Day 34 ] 2.Incidence of Treatment-emergent Adverse Events (TEAEs) of PF-07321332/ritonavir relative to placebo of PF-07321332/ritonavir relative to placebo [ Time Frame: Day 1 through Day 34 ] 3.Duration of each targeted COVID-19 sign/symptom [ Time Frame: Day 1 through Day 28 ] 4.Severity of each targeted COVID-19 sign/symptom [ Time Frame: Day 1 through Day 28 ] 5.Proportion of participants with death (all cause) [ Time Frame: Day 1 through Week 24 ] 6.To determine the pharmacokinetics (PK) in plasma and whole blood of PF-07321332 [ Time Frame: Day 1 through Day 5 ] 7.Viral titers measured by Reverse Transcription Polymerase Chain Reaction (RT-PCR) in nasal swabs [ Time Frame: Day 1 through Day 14 ] 8.Number of COVID-19 related medical visits other than hospitalization [ Time Frame: Day 1 through Day 34 ] 9.Number of days in hospital and intensive care unit for the treatment of COVID-19 [ Time Frame: Day 1 through Day 34 ] | — |
Countries
Argentina, Brazil, Bulgaria, Columbia, Czech Republic, Holland, Hungary, India, Japan, Korea, Malaysia, Mexico, Peru, Poland, Puerto Rico, Russian Federation, South Africa, Spain, Taiwan, Turkey, Ukraine, United States
Contacts
Public ContactClinical Trials Information Desk
Pfizer R&D Japan G.K.
Outcome results
None listed