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

NCT ID: NCT06928051

Last Updated: 2025-09-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 282 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-06
• Study Completion Date: 2025-09-22

Brief 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.

Conditions

COVID-19

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

S-892216: Dose 1

Participants will receive S-892216.

Group Type: EXPERIMENTAL

S-892216

Intervention Type: DRUG

S-892216 will be administered orally as a tablet.

Placebo

Intervention Type: DRUG

Placebo will be administered orally as a tablet.

S-892216: Dose 2

Participants will receive S-892216.

Group Type: EXPERIMENTAL

S-892216

Intervention Type: DRUG

S-892216 will be administered orally as a tablet.

S-892216: Dose 3

Participants will receive S-892216.

Group Type: EXPERIMENTAL

S-892216

Intervention Type: DRUG

S-892216 will be administered orally as a tablet.

Placebo

Participants will receive placebo.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo will be administered orally as a tablet.

Interventions

S-892216

S-892216 will be administered orally as a tablet.

Intervention Type: DRUG

Placebo

Placebo will be administered orally as a tablet.

Intervention Type: DRUG

Eligibility Criteria

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
• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shionogi

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Palm Springs Community Health Center

Miami Lakes, Florida, United States

Quality Research of South Florida

Miami Lakes, Florida, United States

Oceane7 Medical & Research Center, Inc.

Miami Lakes, Florida, United States

Combined Research Orlando Phase I-IV LLC

Orlando, Florida, United States

Global Clinical Professionals

St. Petersburg, Florida, United States

Balanced Life Health Care Solutions

Lawrenceville, Georgia, United States

PanAmerican Clincal Research

Brownsville, Texas, United States

Alina Clinical Trials LLC

Dallas, Texas, United States

Care United Research, LLC

Forney, Texas, United States

Clinical Research Partners LLC

Richmond, Virginia, United States

Frontier Clinical Research LLC

Kingwood, West Virginia, United States

Japanese Site 10

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Countries

United States; Japan

Other Identifiers

2314T1621

Identifier Type: -

Identifier Source: org_study_id