Study of Secutrelvir in Participants With COVID-19

ConditionCOVID-19

Trial statusRecruiting

Trial phasePhase 3

Trial typeInterventional

Biological sexAll

Age12-74

SponsorShionogi

About this trial

The main purpose of this study is to compare secutrelvir to placebo with respect to resolution of clinical symptoms in nonhospitalized participants with Coronavirus Disease 2019 (COVID-19) starting intervention within 48 hours of COVID-19 symptom onset.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

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

1,200 Participants

are divided into 2 treatment groups

Group A: SecutrelvirExperimental treatment 1 intervention

Group B: PlaceboPlacebo comparator 1 intervention