COVID-19 COVID-19
Conditions
Interventions
Secutrelvir tablet 40 mg,Placebo
Experimental Drug,Placebo Comparator Drug
Secutrelvir,Placebo
Sponsors
Shionogi & Co., Ltd.
Eligibility
Sex/Gender
All
Age
12 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Must be 12 to less than 18 years of age with a body weight more than or equal to 40 kilograms, or more than or equal to 18 and less than 75 years of age regardless of body weight, at the time of signing the informed consent form (ICF)., 2. Must have more than or equal to 1 of the following COVID-19 symptoms of moderate or severe, present within 24 hours prior to randomization: a. Shortness of breath or difficulty breathing b. Cough c. Sore throat d. Stuffy or runny nose e. Chills f. Fatigue g. Body pain or muscle pain or aches h. Headache i. Nausea j. Vomiting k. Diarrhea, 3. Must have body temperature greater than or equal to 37.0 Celsius degree per axillary thermometer at the screening visit., 4. Confirmed SARS-CoV-2 infection as determined by any SARS-CoV-2 test approved according to local regulations from any respiratory tract specimen, collected more than or equal to 48 hours prior to randomization., 5. Must be randomized within 48 hours of COVID-19 symptom onset, defined as the time when the first COVID-19 symptom occurs., 6. Male or female
Exclusion criteria
Exclusion criteria: 1. Documented respiratory infection other than COVID-19 within 14 days prior to the screening visit., 2. Known history of cirrhosis or liver decompensation (including ascites, variceal bleeding, or hepatic encephalopathy)., 3. Suspected or confirmed COVID-19 outside of the current episode within 3 months of randomization., 4. Current severely immunocompromised conditions, 5. Received or expected to receive any other COVID-19-specific therapies within the following timeframes: a. Antiviral agents within 30 days or 5 half-lives (whichever is longer) prior to screening through day 28. b. Anti-SARS-CoV-2 monoclonal antibodies (mAbs) and COVID-19 convalescent plasma within 6 months prior to screening through day 28, 6. Received or expected to receive any of the following drugs within 14 days prior to screening through 24 hours after administration of the investigational intervention: a. Strong CYP3A inducer b. Products containing St. John's wort, 7. Received or expected to receive any of the following drugs on the day of screening through 24 hours after administration of the investigational intervention: a. P-glycoprotein (P-gp) substrate with a narrow therapeutic index
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| First resolution of 14 COVID-19 symptoms Through Day 21 Time to first resolution of 14 COVID-19 symptoms through Day 21 | — |
Secondary
| Measure | Time frame |
|---|---|
| Sustained resolution of 14 COVID-19 symptoms Through Day 28 Time to sustained resolution of 14 COVID-19 symptoms through Day 28,SARS-CoV-2 viral RNA level Day 1, Day 4, Day 8, Day 14, Day 21 and Day 28 Change from baseline in SARS-CoV-2 viral RNA level at each time point,Pharmacokinetics of secutrelvir and its metabolites Day 4 and Day 8 Plasma concentrations of secutrelvir and its metabolites on days 4 and 8,Safety and tolerability following administration of investigational intervention Through Day 28 Adverse events, laboratory tests, vital sign measurements (body temperature, systolic/diastolic blood pressure, pulse rate, and respiratory rate), and peripheral oxygen saturation (SpO2) | — |
Countries
Thailand
Contacts
Public ContactSho Okuda
Shionogi & Co., Ltd.
Outcome results
None listed