Secutrelvir for high-risk COVID-19 patients who are not in hospital

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

This is a Phase 3 interventional trial evaluating the safety and efficacy of secutrelvir versus placebo in symptomatic, nonhospitalized participants aged 12 and up who have confirmed SARS-CoV-2 infection and risk factors for progression. Participants are randomized within 72 hours of symptom onset and will receive either secutrelvir or placebo. The study focuses on those with mild to moderate symptoms to see if the treatment can prevent progression to severe disease. Key eligibility requires recent infection, mild symptoms, and age-appropriate weight or age criteria, with efforts to minimize time from symptom onset to randomization. The trial is sponsored by Shionogi and conducted at three clinical sites in Florida.

Why it matters

Who can join: the full rules

Key Inclusion Criteria:

* Must be 12 to \<18 years of age (where permitted by local regulations) with a body weight ≥40 kilograms, or ≥18 years of age regardless of body weight, at the time of signing the informed consent form.
* Presence of risk factors for progression to severe COVID-19 at the time of screening.
* Must have ≥1 COVID-19 signs/symptoms that are at least mild in severity, and the symptoms must still be present in the 24 hours prior to randomization.
* Confirmed SARS-CoV-2 infection, as determined by any SARS-CoV-2 test (for example, quantitative reverse transcription polymerase chain reaction, antigen test) approved according to local regulations, of any respiratory tract specimen (for example, oropharyngeal, nasopharyngeal or nasal swab, or saliva), collected ≤72 hours prior to randomization.
* Must be randomized within 72 hours of symptom onset, defined as the time when the first COVID-19 symptom occurs.
* Contraceptive use by women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
* A women of childbearing potential must have a negative urine pregnancy test within 24 hours prior to receiving the investigational intervention.
* Unable or unwilling to take other locally available COVID-19 antivirals (for example, nirmatrelvir/ritonavir, molnupiravir, remdesivir, ensitrelvir).

Key Exclusion Criteria:

* Planned \>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

Where it's running

• Las Mercedes Medical Research
  Hialeah, Florida, United States Recruiting
• Continental Clinical Research, LLC
  Miami, Florida, United States Recruiting
• Oceanic Research Group
  North Miami Beach, Florida, United States Recruiting
• Velocity Clinical Research
  Cincinnati, Ohio, United States Recruiting
• Abe Shun Naika Clinic
  Kasugai-Shi, Aiti, Japan Recruiting
• Chiba Aoba Municipal Hospital
  Chiba, Chiba, Japan Recruiting

+1 more sites. See ClinicalTrials.gov for the full list.

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.