> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-of-secutrelvir-in-participants-with-coronavirus-74e62cd0-8421-47a8-9f73-8651dfcd4e2c > Record changed: 2026-11-04 # A Study of Secutrelvir in Participants With Coronavirus Disease 2019 (COVID-19) Who Are at High Risk for Progression to Severe Disease NCT07743580 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07743580) Phase Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07743580) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07743580) Participants 2,000 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07743580) Lead sponsor Shionogi Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07743580) Start date 2026-09-14 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07743580) Number of sites 47 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07743580) ## Title and summary **Summary** The primary purpose of this study is to evaluate the efficacy and safety of secutrelvir in symptomatic nonhospitalized adult and adolescent participants with COVID-19 who are at high risk for progression to severe disease. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07743580) **Short title** A Study of Secutrelvir in Participants With Coronavirus Disease 2019 (COVID-19) Who Are at High Risk for Progression to Severe Disease Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07743580) **Official title** A Phase 3 Randomized, Double-blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Secutrelvir in Participants With COVID-19 Who Are at High Risk for Progression to Severe Disease Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07743580) ## Status and phase **Control arm** Placebo Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07743580) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07743580) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07743580) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07743580) **Phase** Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07743580) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07743580) ## Dates **Completion date** 2028-12-31 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07743580) **First posted** 2026-08-04 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07743580) **Registry last updated** 2026-10-26 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07743580) **Primary completion date** 2028-06-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07743580) **Start date** 2026-09-14 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07743580) ## Size and sites **Participants** 2,000 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07743580) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07743580) **Planned participants** 2,000 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07743580) **Protocol amendments** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07743580) **Number of sites** 47 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07743580) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07743580) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07743580) **Lead sponsor** Shionogi Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07743580) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07743580) ## Identifiers **Registry ID** NCT07743580 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07743580) **ClinicalTrials.gov ID** NCT07743580 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07743580) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07743580) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** Double masking **Masked roles** Participants, Investigators Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07743580) ## Outcomes ### Primary outcomes 1. Proportion of Participants Experiencing Any Component of the Following Composite Endpoint: Targeted Medically Attended Visits (tMAVs) Due to Worsening COVID-19, All-cause Hospitalizations, or All-cause Deaths Timeframe: Baseline through Day 28 ### Secondary outcomes 1. Time to Sustained Resolution of 14 COVID-19 Symptoms Timeframe: Baseline through Day 28 2. Proportion of Participants with tMAVs Due to Worsening COVID-19 Timeframe: Baseline through Day 28 3. Proportion of Participants with All-cause Hospitalization or All-cause Death Timeframe: Baseline through Day 28 4. Proportion of Participants with Hospitalization Due to Worsening COVID-19 Timeframe: Baseline through Day 28 5. Time to First Resolution of 14 COVID-19 Symptoms Timeframe: Baseline through Day 28 6. Time to Sustained Alleviation of 14 COVID 19 Symptoms Timeframe: Baseline through Day 28 7. Time to Sustained Resolution of Each of the 14 COVID-19 Symptoms Timeframe: Baseline through Day 28 8. Time to First Alleviation of 14 COVID-19 Symptoms Timeframe: Baseline through Day 28 9. Change from Baseline in Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Viral Ribonucleic Acid (RNA) Level Timeframe: Baseline through Day 28 10. Number of Participants Returning to Usual Health Timeframe: Baseline through Day 28 11. Number of Participants Returning to Usual Activity Timeframe: Baseline through Day 28 12. Number of Participants Reporting No Symptoms Timeframe: Baseline through Day 28 13. Change from Baseline in EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) Score Timeframe: Baseline through Day 28 14. Plasma Concentration of Secutrelvir and Secutrelvir Metabolites Timeframe: Day 4, Day 8 15. Number of Participants with Treatment-emergent Adverse Events Timeframe: Baseline through Week 24 Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07743580) ## Eligibility **Sex** All **Age groups** Children, Adults, Older adults **Minimum age** 12 Years **Healthy volunteers** No Key Inclusion Criteria: - Must be 12 to <18 years of age (where permitted by local regulations) with a body weight ≥40 kilograms, or ≥18 years of age regardless of body weight, at the time of signing the informed consent form. - Presence of risk factors for progression to severe COVID-19 at the time of screening. - Must have ≥1 COVID-19 signs/symptoms that are at least mild in severity, and the symptoms must still be present in the 24 hours prior to randomization. - Confirmed SARS-CoV-2 infection, as determined by any SARS-CoV-2 test (for example, quantitative reverse transcription polymerase chain reaction, antigen test) approved according to local regulations, of any respiratory tract specimen (for example, oropharyngeal, nasopharyngeal or nasal swab, or saliva), collected ≤72 hours prior to randomization. - Must be randomized within 72 hours of symptom onset, defined as the time when the first COVID-19 symptom occurs. - Contraceptive use by women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. - A women of childbearing potential must have a negative urine pregnancy test within 24 hours prior to receiving the investigational intervention. - Unable or unwilling to take other locally available COVID-19 antivirals (for example, nirmatrelvir/ritonavir, molnupiravir, remdesivir, ensitrelvir). Key Exclusion Criteria: - Planned >24 hours hospitalization for any medical procedure through Day 28. - Documented respiratory infection (for example, influenza, respiratory syncytial virus) other than COVID-19 within the 14 days prior to the screening visit. - Known history of cirrhosis or liver decompensation (including ascites, variceal bleeding, or hepatic encephalopathy). - Known history of any of the following abnormalities in the following clinical laboratory tests (within 6 months prior to the screening visit): - Total bilirubin ≥2\*upper limit of normal (ULN) (except for Gilbert's syndrome) - Aspartate aminotransferase or alanine aminotransferase ≥3\*ULN - Suspected or confirmed COVID-19 unrelated to the current episode within 6 months prior to randomization or, for moderately immunocompromised participants, within 3 months prior to 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-19 or post-acute sequelae of COVID-19 diagnosis. - Current severely immunocompromised conditions. - Received any other COVID-19-specific therapies within the following timeframes: - Antiviral agents (for example, remdesivir, nirmatorelvir/ritonavir, molnupiravir, ensitrelvir) within 30 days or 5 half-lives (whichever is longer) prior to randomization - Anti-SARS-CoV-2 monoclonal antibodies and COVID-19 convalescent plasma within 6 months prior to randomization Note: Other protocol-define criteria apply Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07743580) ## Sites - Hope Clinical Trials - 3970 W Flagler St.Coral Gables, United StatesNot yet recruiting - Continental Clinical Research, LLCMiami, United StatesRecruiting - Reed Medical ResearchMiami, United StatesNot yet recruiting - Kendall South Medical Center Inc.Miami, United StatesNot yet recruiting - Global Clinical ProfessionalsSt. Petersburg, United StatesNot yet recruiting - New Tampa HealthTampa, United StatesNot yet recruiting - Research Bay, Inc.Tampa, United StatesNot yet recruiting - Hometown Urgent Care and ResearchCincinnati, United StatesNot yet recruiting - Velocity Clinical ResearchCincinnati, United StatesRecruiting - Medical Center Unimed EOODSevlievo, BulgariaNot yet recruiting - Medichi Sofia - Medical Center OODSofia, BulgariaNot yet recruiting - MCpulmo-2018 LtdHaskovo, BulgariaNot yet recruiting - Medical Center Medconsult Pleven - Lovech BranchLovech, BulgariaNot yet recruiting - Medical Center Medconsult Pleven OODPleven, BulgariaNot yet recruiting - Abe Shun Naika ClinicKasugai-Shi, JapanRecruiting - Chiba Aoba Municipal HospitalChiba, JapanRecruiting - NHO Fukuoka HospitalFukuoka, JapanRecruiting - Japan Community Health Care Organization Nihonmatsu HospitalNihommatsu, JapanNot yet recruiting - Shinozuka HospitalFujioka-Shi, JapanRecruiting - Shizuka Medical ClinicKoyagimachi, JapanRecruiting - Kikuchi ClinicMaebashi, JapanRecruiting - Tsuchiura Beryl ClinicTakasaki-shi, JapanRecruiting - Toda Internal Medicine & NeurologyAkashi-Shi, JapanRecruiting - Terada Clinic Respiratory Medicine and General PracticeHimeji-shi, JapanRecruiting - Kamezawa ClinicTsuchiura-Shi, JapanRecruiting And 22 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07743580) ## 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. Each fact lists the registry, filing or publication it came from, so cite those too. - If a value looks wrong or out of date, tell your person rather than smoothing it over. 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