SARS-CoV-2Phase 3NCT07743580
A Study of Secutrelvir in Participants With Coronavirus Disease 2019 (COVID-19) Who Are at High Risk for Progression to Severe Disease
A Phase 3 study testing Secutrelvir in people with SARS-CoV-2, run by Shionogi at 51 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- SARS-CoV-2
- What is being tested?
- Secutrelvir
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2,000 participants
- Where
- 51 sitesin 3 countries
- Study dates
- 14 Sep 2026to 31 Dec 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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
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- 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
Trial locations and contacts
51 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
Shionogi Clinical Trials Administrator Clinical Support Help Line contact
51 sites in 3 countries
Japan35 sites, 35 recruiting
- Recruiting
Toda Internal Medicine & Neurology
Akashi-Shi, Hyôgo, 674-0081
- Recruiting
Yujin Suto
Annaka-Shi, Gunma, 379-0116
- Recruiting
Chiba Aoba Municipal Hospital
Chiba, Chiba, 206-0852
- Recruiting
Tokyo Center Clinic
Chuo-Ku, Tokyo, 103-0027
- Recruiting
Nishikasai ekimae Clinic
Edogawa-ku, Tokyo, 134-0088
- Recruiting
Shinozuka Hospital
Fujioka-Shi, Gunma, 375-0017
- Recruiting
NHO Fukuoka Hospital
Fukuoka, Fukuoka, 811-1351
- Recruiting
Tomita Internal Medicine Clinic
Fukuoka, 810-0033
- Recruiting
Terada Clinic Respiratory Medicine and General Practice
Himeji-shi, Hyôgo, 670-0849
- Recruiting
Abe Shun Naika Clinic
Kasugai-Shi, Aiti, 815-0074
- Recruiting
Hosoda Clinic
Katsushika-ku, Tokyo, 124-0021
- Recruiting
Sugiura Clinic
Kawaguchi-shi, Saitama, 332-0012
- Recruiting
Sato Clinic
Kawasaki-shi, Kanagawa, 150-0013
- Recruiting
Shinjo Terasu Clinic
Kawasaki-shi, Kanagawa, 211-0044
- Recruiting
Morishita Ekimae Clinic
Koto-ku, Tokyo, 135-0004
- Recruiting
Shizuka Medical Clinic
Koyagimachi, Gunma, 370-0071
- Recruiting
Kikuchi Clinic
Maebashi, Gunma, 370-3573
- Recruiting
Hirano Clinic
Morioka, Iwate, 020-0132
- Recruiting
Shizuka Medicine Clinic
Musashino, Tokyo, 370-0071
- Recruiting
Nogata Clinic
Nakano-ku, Tokyo, 165-0027
- Not yet recruiting
Japan Community Health Care Organization Nihonmatsu Hospital
Nihommatsu, Fukushima, 964-8501
- Recruiting
NHO Nagasaki Medical Cente
Omura-Shi, Nagasaki, 856-8562
- Recruiting
Miura Ken Clinic
Ōta-ku, Tokyo, 114-0046
- Recruiting
Saga Memorial Hospital,
Saga, Saga-ken, 849-0917
- Recruiting
Shibasaki Internal Medicine and Pediatrics Clinic
Sendai, Miyagi, 980-0871
- Recruiting
Matsuo Kenko Clinic
Sendai, Miyagi, 981-0907
- Recruiting
Yotsuya Naika
Shibuya-Ku, Tokyo, 160-0017
- Recruiting
Omi Medical Center
Shiga, Kusatsu, 525-8585
- Recruiting
Medical Corporation Shirayurikai Swing Nozaki Clinic
Shinjuku-Ku, Tokyo, 180-0022
- Recruiting
Tsuchiura Beryl Clinic
Takasaki-shi, Gunma, 300-0062
- Recruiting
Okura ENT Clinic
Toshima-ku, Tokyo, 170-0005
- Recruiting
Sekino Hospital
Toshima-Ku, Tokyo, 171-0014
- Recruiting
Takeuchi Clinic
Toyama, Toyama, 939-8272
- Recruiting
Kamezawa Clinic
Tsuchiura-Shi, Ibaraki, 486-0817
- Recruiting
University of Tsukuba Hospital
Tsukuba, Ibaraki, 305-8576
United States11 sites, 11 recruiting
- Not yet recruiting
Hometown Urgent Care and Research
Cincinnati, Ohio, 45215-1170
- Recruiting
Velocity Clinical Research
Cincinnati, Ohio, 45246
- Not yet recruiting
Hope Clinical Trials - 3970 W Flagler St.
Coral Gables, Florida, 33134-1642
- Recruiting
Las Mercedes Medical Research
Hialeah, Florida, 33012
- Recruiting
Continental Clinical Research, LLC
Miami, Florida, 33144-4273
- Not yet recruiting
Reed Medical Research
Miami, Florida, 33176-8709
- Not yet recruiting
Kendall South Medical Center Inc.
Miami, Florida, 33185-5948
- Recruiting
Oceanic Research Group
North Miami Beach, Florida, 33169-5513
- Not yet recruiting
Global Clinical Professionals
St. Petersburg, Florida, 33705
- Not yet recruiting
New Tampa Health
Tampa, Florida, 33603-3402
- Not yet recruiting
Research Bay, Inc.
Tampa, Florida, 33607
Bulgaria5 sites, 5 recruiting
- Not yet recruiting
MCpulmo-2018 Ltd
Haskovo, 6300
- Not yet recruiting
Medical Center Medconsult Pleven - Lovech Branch
Lovech, 5500
- Not yet recruiting
Medical Center Medconsult Pleven OOD
Pleven, 5800
- Not yet recruiting
Medical Center Unimed EOOD
Sevlievo, Gabrovo, 5402
- Not yet recruiting
Medichi Sofia - Medical Center OOD
Sofia, Sofia, 1113
About this study
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
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.
- Conditions
- SARS-CoV-2
- Being tested
- Secutrelvir, Placebo
- Keywords
- SARS-CoV-2, COVID-19, Secutrelvir, S-892216
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SecutrelvirDrug
Also called S-892216
Secutrelvir will be administered orally as a tablet.
PlaceboDrug
Placebo will be administered orally as a tablet.
| Study group | Role | What they receive |
|---|---|---|
| Secutrelvir | Experimental | Participants will receive secutrelvir. Receives: Drug: Secutrelvir |
| Placebo | Placebo comparator | Participants will receive placebo. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline through Day 28
Secondary outcomes (15)
Time to Sustained Resolution of 14 COVID-19 Symptoms
Measured: Baseline through Day 28
Proportion of Participants with tMAVs Due to Worsening COVID-19
Measured: Baseline through Day 28
Proportion of Participants with All-cause Hospitalization or All-cause Death
Measured: Baseline through Day 28
Proportion of Participants with Hospitalization Due to Worsening COVID-19
Measured: Baseline through Day 28
Time to First Resolution of 14 COVID-19 Symptoms
Measured: Baseline through Day 28
Time to Sustained Alleviation of 14 COVID 19 Symptoms
Measured: Baseline through Day 28
Time to Sustained Resolution of Each of the 14 COVID-19 Symptoms
Measured: Baseline through Day 28
Time to First Alleviation of 14 COVID-19 Symptoms
Measured: Baseline through Day 28
Change from Baseline in Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Viral Ribonucleic Acid (RNA) Level
Measured: Baseline through Day 28
Number of Participants Returning to Usual Health
Measured: Baseline through Day 28
Number of Participants Returning to Usual Activity
Measured: Baseline through Day 28
Number of Participants Reporting No Symptoms
Measured: Baseline through Day 28
Change from Baseline in EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) Score
Measured: Baseline through Day 28
Plasma Concentration of Secutrelvir and Secutrelvir Metabolites
Measured: Day 4, Day 8
Number of Participants with Treatment-emergent Adverse Events
Measured: Baseline through Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2026
- Study start14 Sep 2026
- Primary completion30 Jun 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SARS-CoV-2Studies of the same condition, open and under way.
- More trials run by ShionogiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shionogi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Shionogi Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07743580
- Sponsor's protocol ID
- 2513T1632
- Status last verified
- Oct 2026
- First submitted
- 30 Jul 2026
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07743580
- Acronym / sponsor ID
- 2513T1632
- Conditions
- SARS-CoV-2
- Keywords
- SARS-CoV-2, COVID-19, Secutrelvir, S-892216
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- ShionogiIndustry (pharma, biotech, devices)
- Study start
- 14 Sep 2026 (actual)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 4 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Secutrelvir | Experimental | Drug: SecutrelvirParticipants will receive secutrelvir. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants will receive placebo. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (14 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SecutrelvirAlso: S-892216Secutrelvir will be administered orally as a tablet. | Drug | Secutrelvir |
| PlaceboPlacebo will be administered orally as a tablet. | Drug | Placebo |
Primary outcome
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
Time frame: Baseline through Day 28
15 secondary outcomes
Time to Sustained Resolution of 14 COVID-19 Symptoms
Time frame: Baseline through Day 28
Proportion of Participants with tMAVs Due to Worsening COVID-19
Time frame: Baseline through Day 28
Proportion of Participants with All-cause Hospitalization or All-cause Death
Time frame: Baseline through Day 28
Proportion of Participants with Hospitalization Due to Worsening COVID-19
Time frame: Baseline through Day 28
Time to First Resolution of 14 COVID-19 Symptoms
Time frame: Baseline through Day 28
Time to Sustained Alleviation of 14 COVID 19 Symptoms
Time frame: Baseline through Day 28
Time to Sustained Resolution of Each of the 14 COVID-19 Symptoms
Time frame: Baseline through Day 28
Time to First Alleviation of 14 COVID-19 Symptoms
Time frame: Baseline through Day 28
Change from Baseline in Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Viral Ribonucleic Acid (RNA) Level
Time frame: Baseline through Day 28
Number of Participants Returning to Usual Health
Time frame: Baseline through Day 28
Number of Participants Returning to Usual Activity
Time frame: Baseline through Day 28
Number of Participants Reporting No Symptoms
Time frame: Baseline through Day 28
Change from Baseline in EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) Score
Time frame: Baseline through Day 28
Plasma Concentration of Secutrelvir and Secutrelvir Metabolites
Time frame: Day 4, Day 8
Number of Participants with Treatment-emergent Adverse Events
Time frame: Baseline through Week 24
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Shionogi Clinical Trials Administrator Clinical Support Help Line contact
Medical Director study director
Shionogi Inc.
51 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Secutrelvir in people with SARS-CoV-2, run by Shionogi at 51 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 51 sites in Japan, United States, Bulgaria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shionogi Clinical Trials Administrator Clinical Support Help Line (1-800-849-9707, Shionogiclintrials-admin@shionogi.co.jp), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: Baseline through Day 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.