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 Infectio
- Conditions
- COVID-19
- Registration Number
- JPRN-jRCT2031210349
- Lead Sponsor
- Kawai Norisuke
- Brief Summary
The 5-day and 10-day regimens of nirmatrelvir/ritonavir vs placebo showed a risk reduction of 29.8% and 35.5%, respectively, for symptomatic RT-PCR or RAT confirmed SARS-CoV-2 infection through Day 14 in participants who had a negative RT-PCR result at baseline and were household contacts of an individual with symptomatic COVID-19. The 5-day and 10-day regimens of nirmatrelvir/ritonavir was safe and well-tolerated.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 2957
*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
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method