COVID-19
Conditions
Keywords
S-892216, SARS-CoV-2, Mpro, Main Protease, Nonstructural Protein 5, nsp5
Brief summary
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.
Interventions
DRUGSecutrelvir
Secutrelvir will be administered orally as a tablet.
DRUGPlacebo
Placebo will be administered orally as a tablet.
Sponsors
Shionogi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
12 Years to 74 Years
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * 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. * Agrees not to participate in another clinical study for the treatment of COVID-19 until completion of the study. Key
Exclusion criteria
* 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. * Suspected or confirmed concurrent active systemic infection other than COVID-19 that may interfere with the evaluation of response to the investigational intervention. * Ongoing long COVID or postacute sequelae of COVID (PASC) diagnosis. * Current severely immunocompromised conditions. * Received or expected to receive any other COVID-19-specific therapies. * Have previously received secutrelvir. * Exposed to an investigational drug within 30 days or 5 half-lives (whichever is longer) prior to the screening visit. Note: Other protocol-defined inclusion and
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to First Resolution of 14 Protocol-defined Symptoms of COVID-19 Through Day 21 | Baseline through Day 21 | Symptoms will be assessed by the investigator via a participant daily electronic diary. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Sustained Resolution of 14 Protocol-defined Symptoms of COVID-19 Through Day 28 | Baseline through Day 28 | Symptoms will be assessed by the investigator via a participant daily electronic diary. |
| Time to Sustained Resolution of 14 Protocol-defined Symptoms of COVID-19 Through Day 21 | Baseline through Day 21 | Symptoms will be assessed by the investigator via a participant daily electronic diary. |
| Time to First Resolution of 14 Protocol-defined Symptoms of COVID-19 Symptoms Through Day 28 | Baseline through Day 28 | Symptoms will be assessed by the investigator via a participant daily electronic diary. |
| Time to First Alleviation of 14 Protocol-defined Symptoms of COVID-19 Through Day 21 | Baseline through Day 21 | Symptoms will be assessed by the investigator via a participant daily electronic diary. |
| Time to Sustained Alleviation of 14 Protocol-defined Symptoms of COVID-19 Through Day 21 | Baseline through Day 21 | Symptoms will be assessed by the investigator via a participant daily electronic diary. |
| Area Under The Curve (AUC) of Change From Baseline in Protocol-defined 14 COVID 19 Symptoms Total Score at Day 8 | Baseline, Day 8 | — |
| Time to First Resolution of Fever Based on Body Temperature | Baseline through Day 28 | Symptoms will be assessed by the investigator via a participant daily electronic diary. |
| Time to Sustained Resolution of Fever Based on Body Temperature | Baseline through Day 28 | Symptoms will be assessed by the investigator via a participant daily electronic diary |
| Change From Baseline in SARS-CoV-2 Viral RNA Level | Baseline through Day 28 | — |
| Percentage of Participants With All-cause Hospitalization | Baseline through Day 21 | — |
| Percentage of Participants With All-cause Death | Baseline through Day 21 | — |
| Plasma Concentration of Secutrelvir and Its Metabolites | Days 4 and 8 | — |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Baseline through Day 28 | — |
Countries
Japan
Contacts
CONTACTShionogi Clinical Trials Administrator Clinical Support Help Line
Outcome results
None listed