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New COVID pill shows promise in early trial

NCT ID NCT06928051

Disease control Sponsor: Shionogi Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 21, 2026 · Updated 1 time

Summary

This completed Phase 2 study tested an oral antiviral drug called S-892216 in 282 adults with mild-to-moderate COVID-19. Participants took either the drug or a placebo tablet for a short time. The main goal was to see if the drug could lower the amount of virus in the nose and throat by day 4. Researchers also tracked how quickly symptoms improved and when the virus became undetectable.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
S-892216 (oral antiviral tablet)
What this could lead to
If successful, this could provide a new oral treatment option for mild-to-moderate COVID-19, helping reduce viral levels and speed recovery.
What could go wrong
This is a Phase 2 trial with 282 participants, so results are still early. The drug may not show a strong enough antiviral effect or could have side effects not yet fully understood.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

282 people

The number who actually took part.

Started

Jun 2025

Finished

Sep 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 64 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Key Inclusion Criteria: * 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. * 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 Key Exclusion Criteria: * 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) * 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.

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Conditions

The condition(s) this trial relates to.

COVID-19

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

COVID-19

Contacts and locations

Locations

  • Advanced Research for Health Improvement LLC

    Immokalee, Florida, 34142, United States

  • Alina Clinical Trials LLC

    Dallas, Texas, 75209, United States

  • Balanced Life Health Care Solutions

    Lawrenceville, Georgia, 30046, United States

  • CCM Clinical Research Group

    Miami, Florida, 33133, United States

  • Care United Research, LLC

    Forney, Texas, 75126, United States

  • Clinical Research Partners LLC

    Richmond, Virginia, 23226, United States

  • Combined Research Orlando Phase I-IV LLC

    Orlando, Florida, 32807, United States

  • Continental Clinical Research

    Miami, Florida, 33144, United States

  • Entrust Clinical Research

    Miami, Florida, 33176, United States

  • Frontier Clinical Research LLC

    Kingwood, West Virginia, 26537, United States

  • Global Clinical Professionals

    St. Petersburg, Florida, 33705, United States

  • Global Health Clinical Trials

    Miami, Florida, 33135, United States

  • Healthstar Research

    Hot Springs, Arkansas, 71913, United States

  • Hope Clinical Trials

    Coral Gables, Florida, 33134, United States

  • Invictus Clinical Research Group LLC

    Coconut Creek, Florida, 33073, United States

  • Japanese Site 1

    Multiple Locations, Japan

  • Japanese Site 10

    Multiple Locations, Japan

  • Japanese Site 11

    Multiple Locations, Japan

  • Japanese Site 12

    Multiple Locations, Japan

  • Japanese Site 13

    Multiple Locations, Japan

  • Japanese Site 14

    Multiple Locations, Japan

  • Japanese Site 15

    Multiple Locations, Japan

  • Japanese Site 16

    Multiple Locations, Japan

  • Japanese Site 17

    Multiple Locations, Japan

  • Japanese Site 18

    Multiple Locations, Japan

  • Japanese Site 19

    Multiple Locations, Japan

  • Japanese Site 2

    Multiple Locations, Japan

  • Japanese Site 20

    Multiple Locations, Japan

  • Japanese Site 21

    Multiple Locations, Japan

  • Japanese Site 22

    Multiple Locations, Japan

  • Japanese Site 23

    Multiple Locations, Japan

  • Japanese Site 24

    Multiple Locations, Japan

  • Japanese Site 25

    Multiple Locations, Japan

  • Japanese Site 26

    Multiple Locations, Japan

  • Japanese Site 27

    Multiple Locations, Japan

  • Japanese Site 28

    Multiple Locations, Japan

  • Japanese Site 29

    Multiple Locations, Japan

  • Japanese Site 3

    Multiple Locations, Japan

  • Japanese Site 30

    Multiple Locations, Japan

  • Japanese Site 31

    Multiple Locations, Japan

  • Japanese Site 32

    Multiple Locations, Japan

  • Japanese Site 33

    Multiple Locations, Japan

  • Japanese Site 34

    Multiple Locations, Japan

  • Japanese Site 35

    Multiple Locations, Japan

  • Japanese Site 36

    Multiple Locations, Japan

  • Japanese Site 4

    Multiple Locations, Japan

  • Japanese Site 5

    Multiple Locations, Japan

  • Japanese Site 6

    Multiple Locations, Japan

  • Japanese Site 7

    Multiple Locations, Japan

  • Japanese Site 8

    Multiple Locations, Japan

  • Japanese Site 9

    Multiple Locations, Japan

  • Kendall South Medical Center Inc

    Miami, Florida, 33185, United States

  • LCC Medical Research

    Miami, Florida, 33126, United States

  • Oceane7 Medical & Research Center, Inc.

    Miami Lakes, Florida, 33144, United States

  • Palm Springs Community Health Center

    Miami Lakes, Florida, 33014, United States

  • PanAmerican Clincal Research

    Brownsville, Texas, 78520, United States

  • Quality Research of South Florida

    Miami Lakes, Florida, 33016, United States

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