Ireland
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Recruiting Phase 3

Study of Secutrelvir in Participants With COVID-19

NCT07746544 · tracked via the Priya Life Science Japan tracker
Sponsor
Phase
Phase 3
Started
2026-08-05
Last updated
2026-09-02

Condition(s) studied

COVID-19

Investigational drug(s) / intervention(s)

Secutrelvir →Placebo

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

Sex
ALL
Min age
12 Years
Max age
74 Years
Healthy volunteers
No
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)

FacilityCityRegionStatus
Japanese Site 1 Multiple Locations Japan Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07746544 on ClinicalTrials.gov ↗ ← All trials in Japan