A Study of a Potential Oral Treatment to Prevent COVID-19 in Adults Who Are Exposed to Household Member(s) With a Confirmed Symptomatic COVID-19 Infection
- Conditions
- COVID-19
- Registration Number
- jRCT2031210349
- Lead Sponsor
- Pfizer Japan Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 2880
*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
*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
Study & Design
- Study Type
- Interventional
- Study Design
- parallel assignment
- Primary Outcome Measures
Name Time Method 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 Day 1 through Day 14 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
- Secondary Outcome Measures
Name Time Method Proportion of participants with symptomatic, RT-PCR or Rapid Antigen Test confirmed SARS-CoV-2 infection Day 1 through Day 14 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 Day 1 through Day 28 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 COVID-19 related hospitalization or death from any cause by Day 28.
Proportion of participants with symptomatic or asymptomatic RT-PCR or Rapid Antigen Test confirmed SARS-CoV-2 infection Day 1 through Day 14 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.
Time to RT-PCR confirmed SARS-CoV-2 infection 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 Day 1 through Day 28 Of the participants who have a negative RT-PCR result at baseline: 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 Day 1 through Day 28 Of the participants who have a negative RT-PCR result at baseline: 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 Of the participants who have a negative RT-PCR result at baseline: Pharmacokinetics of PF-07321332 (Day 1 post dose and Day 5 pre dose).
All cause mortality in participants Day 1 through Day 38 Of the participants who have a negative RT-PCR result at baseline: All cause mortality in participants from Day 1 through Day 38.
Viral titers measured via RT-PCR in nasal swabs Day 1 through Day 14 Of the participants who have a negative RT-PCR result at baseline: 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 Day 1 through Day 28 Of the participants who have a negative RT-PCR result at baseline: 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 Day 1 through Day 28 Of the participants who have a negative RT-PCR result at baseline: Number of COVID-19 related medical visits from Day 1 through Day 28.
Percentage of participants who experience adverse events Day 1 through Day 38 Percentage of participants who experience adverse events from Day 1 through Day 38.