Recruiting
Phase 3
Study of Secutrelvir in Participants With COVID-19
Condition(s) studied
COVID-19
Investigational drug(s) / intervention(s)
Secutrelvir: Secutrelvir will be administered orally as a tablet.
Placebo: Placebo will be administered orally as a tablet.
Study summary
The main purpose of this study is to compare secutrelvir to placebo with respect to resolution of clinical symptoms in nonhospitalized participants with Coronavirus Disease 2019 (COVID-19) starting intervention within 48 hours of COVID-19 symptom onset.
Eligibility
Key Inclusion Criteria:
* Must be 12 to \< 18 years of age (where permitted by local regulation) with a body weight ≥ 40 kilograms (kg), or ≥ 18 and \< 75 years of age regardless of body weight, at the time of signing the informed consent form (ICF).
* Must have ≥ 1 of the protocol-defined COVID-19 symptoms of moderate or severe, present within 24 hours prior to randomization.
* Confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection as determined by any SARS-CoV-2 test, collected ≤ 48 hours prior to randomization.
* Must be randomized within 48 hours of COVID-19 symptom onset, defined as the time when the first COVID-19 symptom occurs.
* Agrees not to participate in another clinical study for the treatment of COVID-19 until completion of the study.
Key Exclusion Criteria:
* Current need or anticipated need for hospitalization within 24 hours, due to signs of severe COVID-19 illness or due to other medical conditions requiring hospitalization in the opinion of the site investigator.
* Documented respiratory infection (for example, influenza, respiratory syncytial virus infection) other than COVID 19 within 14 days prior to the screening visit.
* Known history of cirrhosis or liver decompensation (including ascites, variceal bleeding, or hepatic encephalopathy).
* Suspected or confirmed COVID-19 outside of the current episode within 3 months of 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 or postacute sequelae of COVID (PASC) diagnosis.
* Current severely immunocompromised conditions.
* Received or expected to receive any other COVID-19-specific therapies.
* Have previously received secutrelvir.
* Exposed to an investigational drug within 30 days or 5 half-lives (whichever is longer) prior to the screening visit.
Note: Other protocol-defined inclusion and exclusion criteria may apply.
Primary outcome measure(s)
- Time to First Resolution of 14 Protocol-defined Symptoms of COVID-19 Through Day 21 — Baseline through Day 21
Symptoms will be assessed by the investigator via a participant daily electronic diary.
Trial sites (1)
| Facility | City | Region | Status |
| Japanese Site 1 |
Multiple Locations |
Japan |
Recruiting |
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