COVID-19Phase 3NCT07746544
Study of Secutrelvir in Participants With COVID-19
A Phase 3 study testing Secutrelvir in people with COVID-19, run by Shionogi at 1 site in Japan.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 74 years
- Conditions the study is for
- COVID-19
- 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
- 1,200 participants
- Where
- 1 siteJapan
- Study dates
- 5 Aug 2026to 31 Aug 2027
- 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 to 74 years
- 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 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Shionogi Clinical Trials Administrator Clinical Support Help Line contact
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
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.
- Conditions
- COVID-19
- Being tested
- Secutrelvir, Placebo
- Keywords
- S-892216, SARS-CoV-2, Mpro, Main Protease, Nonstructural Protein 5, nsp5
- 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 administered orally. Receives: Drug: Secutrelvir |
| Placebo | Placebo comparator | Participants will receive placebo administered orally. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline through Day 21
Secondary outcomes (13)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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
Measured: Baseline through Day 28
Change From Baseline in SARS-CoV-2 Viral RNA Level
Measured: Baseline through Day 28
Percentage of Participants With All-cause Hospitalization
Measured: Baseline through Day 21
Percentage of Participants With All-cause Death
Measured: Baseline through Day 21
Plasma Concentration of Secutrelvir and Its Metabolites
Measured: Days 4 and 8
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Measured: Baseline through Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2026
- Study start5 Aug 2026
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shionogi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07746544
- Sponsor's protocol ID
- 2512T1631
- Status last verified
- Aug 2026
- First submitted
- 17 Jul 2026
- Last updated
- 2 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 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
- ClinicalTrials.gov ID
- NCT07746544
- Acronym / sponsor ID
- 2512T1631
- Conditions
- COVID-19
- Keywords
- S-892216, SARS-CoV-2, Mpro, Main Protease, Nonstructural Protein 5, nsp5
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- ShionogiIndustry (pharma, biotech, devices)
- Study start
- 5 Aug 2026 (actual)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 5 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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Secutrelvir | Experimental | Drug: SecutrelvirParticipants will receive secutrelvir administered orally. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants will receive placebo administered orally. |
Who may qualify
- Ages
- 12 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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 (11 listed)
- 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.
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
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.
13 secondary outcomes
Time to Sustained Resolution of 14 Protocol-defined Symptoms of COVID-19 Through Day 28
Time frame: Baseline through Day 28
Time to Sustained Resolution of 14 Protocol-defined Symptoms of COVID-19 Through Day 21
Time frame: Baseline through Day 21
Time to First Resolution of 14 Protocol-defined Symptoms of COVID-19 Symptoms Through Day 28
Time frame: Baseline through Day 28
Time to First Alleviation of 14 Protocol-defined Symptoms of COVID-19 Through Day 21
Time frame: Baseline through Day 21
Time to Sustained Alleviation of 14 Protocol-defined Symptoms of COVID-19 Through Day 21
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
Time frame: Baseline through Day 28
Time to Sustained Resolution of Fever Based on Body Temperature
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
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 2 Sep 2026.
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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
1 site in 1 country: 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 COVID-19, run by Shionogi at 1 site in Japan.
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 5 inclusion and 11 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 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. 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?
Time to First Resolution of 14 Protocol-defined Symptoms of COVID-19 Through Day 21 (time frame: Baseline through Day 21). 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 2 Sep 2026.