EPIC-HR: Study of Oral PF-07321332/Ritonavir Compared With Placebo in Nonhospitalized High Risk Adults With COVID-19
- Conditions
- COVID-19
- Registration Number
- JPRN-jRCT2031210267
- Lead Sponsor
- Kawai Norisuke
- Brief Summary
Treatment with nirmatrelvir/ritonavir was efficacious in reducing the incidence of COVID-19-related hospitalization or death from any cause in nonhospitalized symptomatic adult participants with COVID-19 who were at increased risk of progression to severe disease. Treatment with nirmatrelvir/ritonavir was safe and well tolerated.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 2246
*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
*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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method