Study of Secutrelvir in Participants With COVID-19
- 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.
- Short title
- Study of Secutrelvir in Participants With COVID-19
- Official title
- A Phase 3 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Secutrelvir in Participants With COVID-19
- Control arm
- Placebo
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Completion date
- 2027-08-31
- First posted
- 2026-08-05
- Registry last updated
- 2026-09-02
- Primary completion date
- 2027-07-31
- Start date
- 2026-08-05
- Participants
- 1,200
- Participant count basis
- Estimated
- Planned participants
- 1,200
- Protocol amendments
- Number of sites
- Registry sponsor category
- Industry
- Lead sponsor
- Shionogi
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT07746544
- ClinicalTrials.gov ID
- NCT07746544
- Registry record
- Open registry record
- Allocation
- Randomised
- Model
- Parallel groups
- Purpose
- Treatment
- Masking
- Quadruple masking
- Masked roles
- Participants, Care providers, Investigators, Outcome assessors
Time to First Resolution of 14 Protocol-defined Symptoms of COVID-19 Through Day 21
Timeframe: Baseline through Day 21
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 28
Timeframe: 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
Timeframe: 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
Timeframe: 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
Timeframe: 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
Timeframe: 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
Timeframe: Baseline, Day 8
Time to First Resolution of Fever Based on Body Temperature
Timeframe: 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
Timeframe: 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
Timeframe: Baseline through Day 28
Percentage of Participants With All-cause Hospitalization
Timeframe: Baseline through Day 21
Percentage of Participants With All-cause Death
Timeframe: Baseline through Day 21
Plasma Concentration of Secutrelvir and Its Metabolites
Timeframe: Days 4 and 8
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Timeframe: Baseline through Day 28
- Sex
- All
- Age groups
- Children, Adults, Older adults
- Minimum age
- 12 Years
- Maximum age
- 74 Years
- Healthy volunteers
- No
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 exclusion criteria may apply.
- Japanese Site 1Multiple Locations, JapanRecruiting
Related records
Drugs (1)
Lead sponsors (1)
Conditions (1)
- COVID-19 Primary condition