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A Study of S-892216 in Participants With COVID-19 | Clinical Trials | Clareo Health

COMPLETEDPHASE2

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

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

NCT06928051•Shionogi

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.

Eligibility

Age

18 - 64 years

Sex

ALL

Healthy Volunteers

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

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
+6 more criteria

Locations (57)

Healthstar Research

Hot Springs, Arkansas, United States

Invictus Clinical Research Group LLC

Coconut Creek, Florida, United States

Hope Clinical Trials

Coral Gables, Florida, United States

Advanced Research for Health Improvement LLC

Immokalee, Florida, United States

LCC Medical Research

Miami, Florida, United States

CCM Clinical Research Group

Miami, Florida, United States

Global Health Clinical Trials

Miami, Florida, United States

Continental Clinical Research

Miami, Florida, United States

Entrust Clinical Research

Miami, Florida, United States

Kendall South Medical Center Inc

Miami, Florida, United States

Key Dates

Start Date

June 6, 2025

Primary Completion Date

September 22, 2025

Completion Date

September 22, 2025

Last Updated

September 30, 2025

Enrollment

282

ACTUAL participants

Conditions

COVID-19

Interventions

S-892216

DRUG

Placebo

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 30, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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