Secutrelvir for nonhospitalized COVID-19 in teens and adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Participants with COVID-19 who are not in hospital and within 48 hours of symptom onset are randomized to receive either secutrelvir or a placebo. The trial focuses on age groups 12–17 (with weight conditions) and 18–74 irrespective of weight, assessing whether the treatment helps resolve symptoms sooner. It is a Phase 3, randomized, controlled study sponsored by Shionogi at a Japanese site with multiple locations. The primary comparison is time to resolution of clinical symptoms, with safety monitoring ongoing.

Why it matters

Who can join: the full rules

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.

Where it's running

• Japanese Site 1
  Multiple Locations, Japan Recruiting

Study contacts

• Study coordinator: Shionogi Clinical Trials Administrator Clinical Support Help Line
• Email: Shionogiclintrials-admin@shionogi.co.jp
• Phone: 1-800-849-9707

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.