COVID-19
Conditions
Interventions
Participants will receive study drug every 12 hours in one of the following regimen:
PF-07321332/ritonavir from Day 1 to Day 5, followed by placebo from Day 6 to Day 10
or
PF-07321332/ritonavir from D
Sponsors
Kawai Norisuke
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: *Participants who have a negative screening SARS-CoV-2 rapid antigen test result and who are asymptomatic household contacts to an individual who is symptomatic and tested positive for SARS CoV-2 within 96 hours of randomization of the participant. *Fertile participants must agree to use a highly effective method of contraception
Exclusion criteria
Exclusion criteria: *History of SARS-CoV-2 infection in the past 6 months *Experiencing measured fever (>38 degrees) or other signs or symptoms consistent with COVID-19 *Known medical history of active liver disease *Chronic Kidney Disease or have known moderate to severe renal impairment *Known human immunodeficiency virus (HIV) infection with a viral load greater than 400 copies/mL within the last 6 months or taking prohibited medications for HIV treatment *Suspected or confirmed concurrent active systemic infection *Active cancer requiring treatment with prohibited medication *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 approved, authorized, or investigational anti-SARS-CoV-2 mAb, convalescent plasma, other drugs for treatment of COVID-19, or other anti-SARS-CoV-2 biologic products within 6 months of screening *Has received any SARS-CoV-2 vaccine within 6 months prior to screening or is expected to receive a SARS-CoV-2 vaccine or other approved, authorized, or investigational postexposure prophylaxis treatments through Day 38 *Participating in another interventional clinical study with an investigational compound or device, including those for COVID-19 *Known or prior participation in this trial or another trial involving PF-07321332 *Females who are pregnant or breastfeeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of participants who have a negative reverse transcription polymerase chain reaction (RT-PCR) result at baseline who develop a symptomatic, RT-PCR or rapid antigen test confirmed SARS-CoV-2 infection. [ Time Frame: Day 1 through Day 14 ] | — |
Secondary
| Measure | Time frame |
|---|---|
| *Percentage of participants who experience adverse events from Day 1 through Day 38. Of the participants who have a negative RT-PCR result at baseline and who are at increased risk of severe COVID-19 illness: *Proportion of participants with symptomatic, RT-PCR or Rapid Antigen Test confirmed SARS-CoV-2 infection from Day 1 through Day 14. *Proportion of participants with COVID-19 related hospitalization or death from any cause by Day 28. In participants by RT-PCR status at enrolment: *Proportion of participants with symptomatic or asymptomatic RT-PCR or Rapid Antigen Test confirmed SARS-CoV-2 infection from Day 1 through Day 14. Of the participants who have a negative RT-PCR result at baseline: *Time to RT-PCR confirmed SARS-CoV-2 infection from Day 1 through Day 14 *Compare the duration of COVID-19 related signs and symptoms from Day 1 through Day 28. *Compare the severity of COVID-19 related signs and symptoms from Day 1 through Day 28. *Pharmacokinetics of PF-07321332 (Day 1 post dose and Day 5 pre dose). *All cause mortality in participants from Day 1 through Day 38. *Viral titers measured via RT-PCR in nasal swabs from Day 1 through Day 14. *Number of days of hospital and ICU stay in participants with COVID-19 related hospitalization from Day 1 through Day 28. *Number of COVID-19 related medical visits from Day 1 through Day 28. | — |
Countries
Argentina, Brazil, Bulgaria, Columbia, Czech Republic, Hungary, Japan, Malaysia, Mexico, Poland, Puerto Rico, Republic of Korea, Russian Federation, South Africa, Spain, Taiwan, Thailand, Turkey, Ukraine, United States
Contacts
Public ContactClinical Trials Information Desk
Pfizer R&D Japan G.K.
Outcome results
None listed