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NCT07743580
A Study of Secutrelvir in Participants With Coronavirus Disease 2019 (COVID-19) Who Are at High Risk for Progression to Severe Disease
Conditions: SARS-CoV-2
Sex: All
Ages: 12 Years – N/A
Healthy volunteers: No
Phase: PHASE3
Enrollment: 2000
Sponsor: Shionogi
Location: Hope Clinical Trials - 3970 W Flagler St. Coral Gables Florida
Summary
The primary purpose of this study is to evaluate the efficacy and safety of secutrelvir in symptomatic nonhospitalized adult and adolescent participants with COVID-19 who are at high risk for progression to severe disease.
Eligibility Criteria
Key Inclusion Criteria:
* Must be 12 to \24 hours hospitalization for any medical procedure through Day 28.
* Documented respiratory infection (for example, influenza, respiratory syncytial virus) other than COVID-19 within the 14 days prior to the screening visit.
* Known history of cirrhosis or liver decompensation (including ascites, variceal bleeding, or hepatic encephalopathy).
* Known history of any of the following abnormalities in the following clinical laboratory tests (within 6 months prior to the screening visit):
* Total bilirubin ≥2\*upper limit of normal (ULN) (except for Gilbert's syndrome)
* Aspartate aminotransferase or alanine aminotransferase ≥3\*ULN
* Suspected or confirmed COVID-19 unrelated to the current episode within 6 months prior to randomization or, for moderately immunocompromised participants, within 3 months prior to randomization.
* Suspected or confirmed concurrent active systemic infection other than COVID-19 that may interfere with the evaluation of response to the investigational intervention.
* Ongoing long COVID-19 or post-acute sequelae of COVID-19 diagnosis.
* Current severely immunocompromised conditions.
* Received any other COVID-19-specific therapies within the following timeframes:
* Antiviral agents (for example, remdesivir, nirmatorelvir/ritonavir, molnupiravir, ensitrelvir) within 30 days or 5 half-lives (whichever is longer) prior to randomization
* Anti-SARS-CoV-2 monoclonal antibodies and COVID-19 convalescent plasma within 6 months prior to randomization
Note: Other protocol-define criteria apply
Source: ClinicalTrials.gov (NCT07743580). StuddyBuddy aggregates publicly available trial information.