COVID-19Phase 2NCT06928051

A Study of S-892216 in Participants With COVID-19

A Phase 2 study testing S-892216 in people with COVID-19, run by Shionogi at 57 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The primary objective of this study is to investigate the antiviral effect of S-892216 in participants with coronavirus disease 2019 (COVID-19) due to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. Read more about this study

Who is it for?: Ages 18 to 64 years
Conditions the study is for: COVID-19
What is being tested?: S-892216
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 282 participants
Where: 57 sitesin 2 countries
Study dates: 6 Jun 2025to 22 Sep 2025
Phase: Phase 2
Are there results?: None posted in the registry

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 18 to 64 years
All sexes
No healthy volunteers
Adult

Who may be able to join

Must weigh ≥40 kilograms
Must have at least 2 COVID-19 signs/symptoms of mild or higher severity, or at least 1 sign/symptom of moderate or higher severity, within the 72 hours prior to randomization, and the symptoms must still be present in the 24 hours prior to randomization
Documentation of laboratory-confirmed active SARS-CoV-2 infection, as determined by a nucleic acid (for example, qRT-PCR) or antigen test from any respiratory tract specimen (for example, oropharyngeal, NP or nasal swab, or saliva), or any other SARS-CoV-2 test approved according to local regulations, collected ≤72 hours (3 days) prior to randomization
Oxygen saturation (SpO2) of ≥92% on room air adjusted for altitude and obtained at rest by study staff within the 24 hours prior to randomization. For a potential participant who regularly receives chronic supplementary oxygen for an underlying lung condition, SpO2 measured while on standard home oxygen supplementation level must be ≥92%.
Capable and willing to complete an electronic participant diary
Contraceptive use by female participants should be consistent with local regulations regarding the use of contraceptive methods for those participating in clinical studies. Note: The investigational medication may lead to an increase or decrease of sex hormone levels; therefore, hormonal contraception must not be used alone and must be combined with a barrier method.

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A woman of childbearing potential must have a negative urine pregnancy test within the 24 hours before the first dose of investigational intervention
Must be randomized ≤72 hours from onset of COVID-19 symptoms (defined as the time point when at least 1 of the COVID-19 symptoms occurs)
Agrees to not participate in another clinical trial for the treatment of COVID-19 or SARS-CoV-2 during the study period unless meeting hospitalization criteria or reaching Day 28, whichever is earliest

Who cannot join

High risk of progression to severe COVID-19, as defined in the protocol
Documented respiratory infection (for example, influenza, respiratory syncytial virus) other than COVID-19 within the 14 days prior to the screening visit
Known current renal impairment deﬁned as estimated glomerular filtration rate <60 milliliters/minute/1.73 meters squared or requiring dialysis
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 the 6 months prior to the screening visit):
Total bilirubin ≥2 × upper limit of normal (ULN) (except for Gilbert's syndrome)

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Aspartate aminotransferase or alanine aminotransferase ≥2 × ULN
A QT interval corrected using Fridericia's formula at the screening visit:
For males: >450 milliseconds (msec)
For females: >470 msec
History of hospitalization for the current SARS-CoV-2 infection or anticipated need for hospitalization within 24 hours after randomization
History of cancer except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years
Women with a history of osteoporosis
Received or expected to receive any dose of a SARS-CoV-2 vaccine within 14 days of randomization or during the study through day 28
Received or expected to receive any other COVID-19-specific treatment, including outpatient remdesivir, Paxlovid, molnupiravir, monoclonal antibodies, ensitrelvir, and convalescent plasma for the current COVID-19 infection
Exposed to an investigational drug within 30 days or 5 half-lives of the drug prior to the screening visit
Note: Other protocol-defined inclusion/exclusion criteria may apply.

Trial locations and contacts

57 sites in 2 countries.

Country

City, postcode or hospital

57 sites in 2 countries

Japan36 sites

Japanese Site 10
Multiple Locations
Japanese Site 11
Multiple Locations
Japanese Site 12
Multiple Locations
Japanese Site 13
Multiple Locations
Japanese Site 14
Multiple Locations
Japanese Site 15
Multiple Locations
Japanese Site 16
Multiple Locations
Japanese Site 17
Multiple Locations
Japanese Site 18
Multiple Locations
Japanese Site 19
Multiple Locations
Japanese Site 1
Multiple Locations
Japanese Site 20
Multiple Locations
Japanese Site 21
Multiple Locations
Japanese Site 22
Multiple Locations
Japanese Site 23
Multiple Locations
Japanese Site 24
Multiple Locations
Japanese Site 25
Multiple Locations
Japanese Site 26
Multiple Locations
Japanese Site 27
Multiple Locations
Japanese Site 28
Multiple Locations
Japanese Site 29
Multiple Locations
Japanese Site 2
Multiple Locations
Japanese Site 30
Multiple Locations
Japanese Site 31
Multiple Locations
Japanese Site 32
Multiple Locations
Japanese Site 33
Multiple Locations
Japanese Site 34
Multiple Locations
Japanese Site 35
Multiple Locations
Japanese Site 36
Multiple Locations
Japanese Site 3
Multiple Locations
Japanese Site 4
Multiple Locations
Japanese Site 5
Multiple Locations
Japanese Site 6
Multiple Locations
Japanese Site 7
Multiple Locations
Japanese Site 8
Multiple Locations
Japanese Site 9
Multiple Locations

Other trials in Japan

United States21 sites

PanAmerican Clincal Research
Brownsville, Texas, 78520
Invictus Clinical Research Group LLC
Coconut Creek, Florida, 33073
Hope Clinical Trials
Coral Gables, Florida, 33134
Alina Clinical Trials LLC
Dallas, Texas, 75209
Care United Research, LLC
Forney, Texas, 75126
Healthstar Research
Hot Springs, Arkansas, 71913
Advanced Research for Health Improvement LLC
Immokalee, Florida, 34142
Frontier Clinical Research LLC
Kingwood, West Virginia, 26537
Balanced Life Health Care Solutions
Lawrenceville, Georgia, 30046
LCC Medical Research
Miami, Florida, 33126
CCM Clinical Research Group
Miami, Florida, 33133
Global Health Clinical Trials
Miami, Florida, 33135
Continental Clinical Research
Miami, Florida, 33144
Entrust Clinical Research
Miami, Florida, 33176
Kendall South Medical Center Inc
Miami, Florida, 33185
Palm Springs Community Health Center
Miami Lakes, Florida, 33014
Quality Research of South Florida
Miami Lakes, Florida, 33016
Oceane7 Medical & Research Center, Inc.
Miami Lakes, Florida, 33144
Combined Research Orlando Phase I-IV LLC
Orlando, Florida, 32807
Clinical Research Partners LLC
Richmond, Virginia, 23226
Global Clinical Professionals
St. Petersburg, Florida, 33705

Other trials in United States

About this study

Official title: Phase 2 Study of S-892216 in Participants Infected With SARS-CoV-2

Conditions: COVID-19
Being tested: S-892216, Placebo
Keywords: S-892216, Mpro, Main Protease, Nonstructural Protein 5, nsp5, Protease Inhibitor
Medical subject headings: COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

S-892216Drug
S-892216 will be administered orally as a tablet.
PlaceboDrug
Placebo will be administered orally as a tablet.

Study groups in NCT06928051
Study group	Role	What they receive
S-892216: Dose 1	Experimental	Participants will receive S-892216. Receives: Drug: S-892216; Drug: Placebo
S-892216: Dose 2	Experimental	Participants will receive S-892216. Receives: Drug: S-892216
S-892216: Dose 3	Experimental	Participants will receive S-892216. Receives: Drug: S-892216
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.

Change From Baseline in SARS-CoV-2 Viral RNA Level on Day 4 as Assessed by Quantitative Reverse-transcription Polymerase Chain Reaction (qRT-PCR) of Nasopharyngeal (NP) Swabs
Measured: Baseline through Day 4

Secondary outcomes (9)

Time to the First Negative SARS CoV-2 Viral RNA qRT-PCR Result
Measured: Baseline through Day 28
Time to the First SARS CoV-2 Viral RNA Viral RNA Level Less Than the Lower Limit of Quantitation (LLOQ)
Measured: Baseline through Day 28
Number of Participants With a Positive SARS CoV-2 Viral RNA qRT-PCR Test
Measured: Baseline, Days 2, 4, 6, 10, 14, 21, and 28
Change From Baseline in SARS CoV-2 Viral RNA Level
Measured: Baseline, Days 2, 6, 10, 14, 21, and 28
Area Under the Curve of Change From Baseline in SARS-CoV-2 Viral RNA Level Through Day 4 and Day 6
Measured: Baseline through Day 4 and Day 6
Time to Sustained (2 Consecutive Days) Resolution of COVID-19 Symptoms
Measured: Baseline through Day 28
Time to First Resolution of COVID-19 Symptoms
Measured: Baseline through Day 28
Time to Return to Pre-COVID-19 Health
Measured: Baseline through Day 28
Plasma Concentration of S-892216
Measured: Days 2, 6, and 10

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

6 Jun 202522 Sep 2025

First posted15 Apr 2025
Study start6 Jun 2025
Primary completion22 Sep 2025
Study completion22 Sep 2025

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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 282 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06928051
Sponsor's protocol ID: 2314T1621
Status last verified: Mar 2026
First submitted: 9 Apr 2025
Last updated: 21 Sep 2026
Results posted: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All COVID-19 trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase 2 Study of S-892216 in Participants Infected With SARS-CoV-2
ClinicalTrials.gov ID: NCT06928051
Acronym / sponsor ID: 2314T1621
Conditions: COVID-19
Keywords: S-892216, Mpro, Main Protease, Nonstructural Protein 5, nsp5, Protease Inhibitor
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 282 participants (actual)
Lead sponsor: ShionogiIndustry (pharma, biotech, devices)
Study start: 6 Jun 2025 (actual)
Primary completion: 22 Sep 2025 (actual)
Study completion: 22 Sep 2025 (actual)
First posted: 15 Apr 2025 (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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 4

Arm	Type	Receives
S-892216: Dose 1	Experimental	Drug: S-892216, Drug: PlaceboParticipants will receive S-892216.
S-892216: Dose 2	Experimental	Drug: S-892216Participants will receive S-892216.
S-892216: Dose 3	Experimental	Drug: S-892216Participants will receive S-892216.
Placebo	Placebo comparator	Drug: PlaceboParticipants will receive placebo.

Who may qualify

Ages: 18 to 64 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (9 listed)

Must weigh ≥40 kilograms
Must have at least 2 COVID-19 signs/symptoms of mild or higher severity, or at least 1 sign/symptom of moderate or higher severity, within the 72 hours prior to randomization, and the symptoms must still be present in the 24 hours prior to randomization
Documentation of laboratory-confirmed active SARS-CoV-2 infection, as determined by a nucleic acid (for example, qRT-PCR) or antigen test from any respiratory tract specimen (for example, oropharyngeal, NP or nasal swab, or saliva), or any other SARS-CoV-2 test approved according to local regulations, collected ≤72 hours (3 days) prior to randomization
Oxygen saturation (SpO2) of ≥92% on room air adjusted for altitude and obtained at rest by study staff within the 24 hours prior to randomization. For a potential participant who regularly receives chronic supplementary oxygen for an underlying lung condition, SpO2 measured while on standard home oxygen supplementation level must be ≥92%.
Capable and willing to complete an electronic participant diary

Key exclusion criteria (17 listed)

High risk of progression to severe COVID-19, as defined in the protocol
Documented respiratory infection (for example, influenza, respiratory syncytial virus) other than COVID-19 within the 14 days prior to the screening visit
Known current renal impairment deﬁned as estimated glomerular filtration rate <60 milliliters/minute/1.73 meters squared or requiring dialysis
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 the 6 months prior to the screening visit):

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
S-892216S-892216 will be administered orally as a tablet.	Drug	S-892216: Dose 1, S-892216: Dose 2, S-892216: Dose 3
PlaceboPlacebo will be administered orally as a tablet.	Drug	Placebo, S-892216: Dose 1

Primary outcome

Change From Baseline in SARS-CoV-2 Viral RNA Level on Day 4 as Assessed by Quantitative Reverse-transcription Polymerase Chain Reaction (qRT-PCR) of Nasopharyngeal (NP) Swabs
Time frame: Baseline through Day 4

9 secondary outcomes

Time to the First Negative SARS CoV-2 Viral RNA qRT-PCR Result
Time frame: Baseline through Day 28
Time to the First SARS CoV-2 Viral RNA Viral RNA Level Less Than the Lower Limit of Quantitation (LLOQ)
Time frame: Baseline through Day 28
Number of Participants With a Positive SARS CoV-2 Viral RNA qRT-PCR Test
Time frame: Baseline, Days 2, 4, 6, 10, 14, 21, and 28
Change From Baseline in SARS CoV-2 Viral RNA Level
Time frame: Baseline, Days 2, 6, 10, 14, 21, and 28
Area Under the Curve of Change From Baseline in SARS-CoV-2 Viral RNA Level Through Day 4 and Day 6
Time frame: Baseline through Day 4 and Day 6
Time to Sustained (2 Consecutive Days) Resolution of COVID-19 Symptoms
Time frame: Baseline through Day 28
Time to First Resolution of COVID-19 Symptoms
Time frame: Baseline through Day 28
Time to Return to Pre-COVID-19 Health
Time frame: Baseline through Day 28
Plasma Concentration of S-892216
Time frame: Days 2, 6, and 10

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 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. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

57 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing S-892216 in people with COVID-19, run by Shionogi at 57 sites in 2 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 9 inclusion and 17 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: finished, as of the sponsor's last update on 21 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 57 sites in Japan, United States. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in SARS-CoV-2 Viral RNA Level on Day 4 as Assessed by Quantitative Reverse-transcription Polymerase Chain Reaction (qRT-PCR) of Nasopharyngeal (NP) Swabs (time frame: Baseline through Day 4). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06928051.

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 21 Sep 2026.