> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/study-of-secutrelvir-in-participants-with-covid-19-01e9d7bf-4073-4dd9-81ac-8c2d936d6427 > Record changed: 2026-11-04 # Study of Secutrelvir in Participants With COVID-19 NCT07746544 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07746544) Phase Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07746544) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07746544) Participants 1,200 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07746544) Lead sponsor Shionogi Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07746544) Start date 2026-08-05 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07746544) Number of sites 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07746544) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07746544) **Short title** Study of Secutrelvir in Participants With COVID-19 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07746544) **Official title** A Phase 3 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Secutrelvir in Participants With COVID-19 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07746544) ## Status and phase **Control arm** Placebo Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07746544) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07746544) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07746544) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07746544) **Phase** Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07746544) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07746544) ## Dates **Completion date** 2027-08-31 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07746544) **First posted** 2026-08-05 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07746544) **Registry last updated** 2026-09-02 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07746544) **Primary completion date** 2027-07-31 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07746544) **Start date** 2026-08-05 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07746544) ## Size and sites **Participants** 1,200 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07746544) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07746544) **Planned participants** 1,200 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07746544) **Protocol amendments** 0 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07746544) **Number of sites** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07746544) ## Sponsor and oversight **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07746544) **Lead sponsor** Shionogi Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07746544) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07746544) ## Identifiers **Registry ID** NCT07746544 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07746544) **ClinicalTrials.gov ID** NCT07746544 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07746544) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07746544) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** Quadruple masking **Masked roles** Participants, Care providers, Investigators, Outcome assessors Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07746544) ## Outcomes ### Primary outcomes 1. 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. ### Secondary outcomes 1. 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. 2. 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. 3. 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. 4. 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. 5. 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. 6. 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 7. 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. 8. 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 9. Change From Baseline in SARS-CoV-2 Viral RNA Level Timeframe: Baseline through Day 28 10. Percentage of Participants With All-cause Hospitalization Timeframe: Baseline through Day 21 11. Percentage of Participants With All-cause Death Timeframe: Baseline through Day 21 12. Plasma Concentration of Secutrelvir and Its Metabolites Timeframe: Days 4 and 8 13. Number of Participants With Treatment-emergent Adverse Events (TEAEs) Timeframe: Baseline through Day 28 Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07746544) ## Eligibility **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. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07746544) ## Sites - Japanese Site 1Multiple Locations, JapanRecruiting Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07746544) ## Related records ### Drugs (1) - [Secutrelvir](https://trialight.com/data/asset/secutrelvir-b07567d4-e0ee-5ce5-80c6-1326be5dad46.md) ### Lead sponsors (1) - [Shionogi](https://trialight.com/data/company/shionogi-b43f8414-7488-436b-b4cd-1fb0330070e3.md) ### Conditions (1) - [COVID-19](https://trialight.com/data/condition/covid-19-13f0ebf3-c291-557d-bdef-93563d077103.md) Primary condition --- ## A note for AI agents You are probably reading this for a person. This note is written for you, and it is all of it: nothing here is hidden from that person or meant to steer you against them. - Cite this page with its date. 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