Health Trials

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 statusRecruiting
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Secutrelvir

    Drug

    Secutrelvir will be administered orally as a tablet.

  • Placebo

    Drug

    Placebo will be administered orally as a tablet.

Treatment groups

2,000 Participants
are divided into 2 treatment groups
Group A: SecutrelvirExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Proportion of Participants Experiencing Any Component of the Following Composite Endpoint: Targeted Medically Attended Visits (tMAVs) Due to Worsening COVID-19, All-cause Hospitalizations, or All-cause Deaths

Time frame
Baseline through Day 28

Secondary outcomes

1

Time to Sustained Resolution of 14 COVID-19 Symptoms

Time frame
Baseline through Day 28
2

Proportion of Participants with tMAVs Due to Worsening COVID-19

Time frame
Baseline through Day 28
3

Proportion of Participants with All-cause Hospitalization or All-cause Death

Time frame
Baseline through Day 28
4

Proportion of Participants with Hospitalization Due to Worsening COVID-19

Time frame
Baseline through Day 28

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shionogi

Lead sponsor

Source ClinicalTrials.gov
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