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

ConditionSARS-CoV-2
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age12+
SponsorShionogi

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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).

Total bilirubin ≥2*upper limit of normal (ULN) (except for Gilbert's syndrome)

Trial design

Treatments tested in this trial

  • Secutrelvir
  • Placebo

Treatment groups

2,000 Participants
are divided into 2 treatment groups

Sponsors and collaborators