Evaluation of Protease Inhibition for COVID-19 in Standard-Risk Patients (EPIC-SR).
- Conditions
- COVID-19
- Registration Number
- JPRN-jRCT2031210274
- Lead Sponsor
- Kawai Norisuke
- Brief Summary
irmatrelvir/ritonavir reduced the time to sustained alleviation of all targeted signs and symptoms through Day 28, but the difference was not statistically significant and the study primary objective was not met; the secondary analysis results were not statistically significant despite some positive results. The antiviral effect of nirmatrelvir/ritonavir was demonstrated by a significant reduction of SARS-CoV-2 viral load compared with placebo at Day 5. Nirmatrelvir/ritonavir was safe and well tolerated.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 1288
* Confirmed SARS-CoV-2 infection 5 days prior to randomization
* Initial onset of COVID-19 signs/symptoms within 5 days of randomization
* Fertile participants must agree to use a highly effective method of contraception
*Has at least one 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 diagnosis of SARS-CoV-2 infection (reinfection)
*Known medical history of liver disease
*Receiving dialysis or have known renal impairment
*Known Human Immunodeficiency Virus (HIV) infection with viral load > 400 copies/ml or taking prohibited medications for HIV treatment
*Suspected or confirmed concurrent active systemic infection other than COVID-19
*Current or expected use of any medications or substances that are highly dependent on Cytochrome P450 3A4 (CYP3A4) for clearance or are strong inducers of CYP3A4
*Has received or is expected to receive monoclonal antibody treatment or convalescent COVID-19 plasma
*Has received any SARS-CoV-2 vaccine within 12 months of screening.
*Participating in another interventional clinical study with an investigational compound or device, including those for COVID-19
*Known prior participation in this trial or other trial involving PF-07321332
*Oxygen saturation of < 92% on room air
*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