A Phase 3 interventional study of Secutrelvir and Placebo in COVID-19, sponsored by Shionogi. Recruiting at 1 site in Japan. Open to participants aged 12 Years to 74 Years. Per ClinicalTrials.gov, last updated 2026-09-02.
Sponsored by Shionogi · Phase 3, Interventional, and Treatment
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.
7,990 studies on the registry are indexed under COVID-19; 466 are open to participants now.
This study's planned enrollment of 1,200 is above the median of 102 across 4,364 interventional studies indexed under COVID-19.
Browse COVID-19 studies →Shionogi is the lead sponsor of 105 studies on the registry; 10 are open to participants now.
Of its 39 completed or terminated interventional studies of FDA-regulated products, 21 (54%) have results posted.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Key Exclusion Criteria:
Note: Other protocol-defined inclusion and exclusion criteria may apply.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive secutrelvir administered orally.
Drug: Secutrelvir
Participants will receive placebo administered orally.
Drug: Placebo
Secutrelvir will be administered orally as a tablet.
Also known as: S-892216
Placebo will be administered orally as a tablet.
Time to First Resolution of 14 Protocol-defined Symptoms of COVID-19 Through Day 21
Symptoms will be assessed by the investigator via a participant daily electronic diary.
Time frame: Baseline through Day 21
Time to Sustained Resolution of 14 Protocol-defined Symptoms of COVID-19 Through Day 28
Symptoms will be assessed by the investigator via a participant daily electronic diary.
Time frame: Baseline through Day 28
Time to Sustained Resolution of 14 Protocol-defined Symptoms of COVID-19 Through Day 21
Symptoms will be assessed by the investigator via a participant daily electronic diary.
Time frame: Baseline through Day 21
Time to First Resolution of 14 Protocol-defined Symptoms of COVID-19 Symptoms Through Day 28
Symptoms will be assessed by the investigator via a participant daily electronic diary.
Time frame: Baseline through Day 28
Time to First Alleviation of 14 Protocol-defined Symptoms of COVID-19 Through Day 21
Symptoms will be assessed by the investigator via a participant daily electronic diary.
Time frame: Baseline through Day 21
Time to Sustained Alleviation of 14 Protocol-defined Symptoms of COVID-19 Through Day 21
Symptoms will be assessed by the investigator via a participant daily electronic diary.
Time frame: Baseline through Day 21
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
Time to First Resolution of Fever Based on Body Temperature
Symptoms will be assessed by the investigator via a participant daily electronic diary.
Time frame: Baseline through Day 28
Time to Sustained Resolution of Fever Based on Body Temperature
Symptoms will be assessed by the investigator via a participant daily electronic diary
Time frame: Baseline through Day 28
Change From Baseline in SARS-CoV-2 Viral RNA Level
Time frame: Baseline through Day 28
Percentage of Participants With All-cause Hospitalization
Time frame: Baseline through Day 21
Percentage of Participants With All-cause Death
Time frame: Baseline through Day 21
Plasma Concentration of Secutrelvir and Its Metabolites
Time frame: Days 4 and 8
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Time frame: Baseline through Day 28
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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