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NCT Number: NCT07746544

Study of Secutrelvir in Participants With COVID-19

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.

Recruiting

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Key information

Age range

12 year–74 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Japanese Site 1

Multiple Locations, Japan

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Secutrelvir

Drug

Secutrelvir will be administered orally as a tablet.

Other names: S-892216

Placebo

Drug

Placebo will be administered orally as a tablet.

Primary outcomes

  1. Time to First Resolution of 14 Protocol-defined Symptoms of COVID-19 Through Day 21

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: Baseline, Day 8

  7. Time to First Resolution of Fever Based on Body Temperature

    Time frame: 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

    Time frame: 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

    Time frame: Baseline through Day 28

  10. Percentage of Participants With All-cause Hospitalization

    Time frame: Baseline through Day 21

  11. Percentage of Participants With All-cause Death

    Time frame: Baseline through Day 21

  12. Plasma Concentration of Secutrelvir and Its Metabolites

    Time frame: Days 4 and 8

  13. Number of Participants With Treatment-emergent Adverse Events (TEAEs)

    Time frame: Baseline through Day 28

Study contacts

Contact information is provided by the study sponsor or research team.

Shionogi Clinical Trials Administrator Clinical Support Help Line

CONTACT

[email protected]

1-800-849-9707

Sponsors and collaborators

Lead sponsor

Shionogi

Industry

Registry information

Official study title

A Phase 3 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Secutrelvir in Participants With COVID-19

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 5, 2026
Registry last updated
Sep 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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