Secutrelvir for High-Risk COVID-19 Patients

A Study of Secutrelvir in Participants With Coronavirus Disease 2019 (COVID-19) Who Are at High Risk for Progression to Severe Disease

Recruiting Phase 3 Interventional Study
SARS-CoV-2
Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
12 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
2,000 (estimated)
Sponsor
Shionogi · Industry
Who this trial is looking for

This trial is looking for teenagers and adults who have mild COVID-19 symptoms and are at high risk of getting severely ill. Participants will take secutrelvir and help researchers understand how well it works and its safety.

Are You a Good Fit for This Trial?
Rules you out Long COVID-19Severe immunocompromised conditions

You may be able to join if

  • I am 12 to 17 years old and weigh at least 40 kg, or I am 18 years or older.
  • I have risk factors that may lead to severe COVID-19.
  • I have at least one mild COVID-19 symptom that has lasted in the last 24 hours.
  • I have a confirmed COVID-19 infection within the last 72 hours.
  • I am willing to participate within 72 hours of when my symptoms started.
  • I use contraception according to local regulations if I can become pregnant.
  • I had a negative urine pregnancy test within 24 hours before the treatment.
  • I cannot take other available COVID-19 antiviral medications.

You may not be able to join if

  • I need to be hospitalized for more than 24 hours for any reason.
  • I had a respiratory infection other than COVID-19 in the last 14 days.
  • I have a history of liver problems like cirrhosis.
  • My lab tests show abnormal liver function.
  • I had suspected or confirmed COVID-19 unrelated to this episode in the last 6 months.
  • I have an ongoing or active infection other than COVID-19.
  • I am currently severely immunocompromised.
  • I received any COVID-19 antiviral treatments in the last 30 days.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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About This Trial

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.

Trial Locations
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Eligibility Criteria
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 ti…
Contacts

Shionogi Clinical Trials Administrator Clinical Support Help Line

1-800-849-9707

Shionogiclintrials-admin@shionogi.co.jp

CONTACT