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

NCT06928051 | Completed Phase 2 FDA Drug

• 1 other identifier: 2314T1621
• Study Type: interventional
• Target: 282
• Locations: 2 countries
• Sites: 57

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

Keywords

S-892216; Mpro; Main Protease; Nonstructural Protein 5; nsp5; Protease Inhibitor

Outcome Measures

Primary Outcomes (1)

• 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

  Baseline through Day 4

Secondary Outcomes (9)

• Time to the First Negative SARS CoV-2 Viral RNA qRT-PCR Result

  Baseline through Day 28

• Time to the First SARS CoV-2 Viral RNA Viral RNA Level Less Than the Lower Limit of Quantitation (LLOQ)

  Baseline through Day 28

• Number of Participants With a Positive SARS CoV-2 Viral RNA qRT-PCR Test

  Baseline, Days 2, 4, 6, 10, 14, 21, and 28

• Change From Baseline in SARS CoV-2 Viral RNA Level

  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

  Baseline through Day 4 and Day 6

Study Arms (4)

S-892216: Dose 1

EXPERIMENTAL

Participants will receive S-892216.

Drug: S-892216; Drug: Placebo

S-892216: Dose 2

EXPERIMENTAL

Participants will receive S-892216.

Drug: S-892216

S-892216: Dose 3

EXPERIMENTAL

Participants will receive S-892216.

Drug: S-892216

Placebo

PLACEBO COMPARATOR

Participants will receive placebo.

Drug: Placebo

Interventions

S-892216 DRUG

S-892216 will be administered orally as a tablet.

S-892216: Dose 1; S-892216: Dose 2; S-892216: Dose 3

Placebo DRUG

Placebo will be administered orally as a tablet.

Placebo; S-892216: Dose 1

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shionogi: lead

Study Sites (57)

Healthstar Research

Hot Springs, Arkansas, 71913, United States

Location

Invictus Clinical Research Group LLC

Coconut Creek, Florida, 33073, United States

Location

Hope Clinical Trials

Coral Gables, Florida, 33134, United States

Location

Advanced Research for Health Improvement LLC

Immokalee, Florida, 34142, United States

Location

LCC Medical Research

Miami, Florida, 33126, United States

Location

CCM Clinical Research Group

Miami, Florida, 33133, United States

Location

Global Health Clinical Trials

Miami, Florida, 33135, United States

Location

Continental Clinical Research

Miami, Florida, 33144, United States

Location

Entrust Clinical Research

Miami, Florida, 33176, United States

Location

Kendall South Medical Center Inc

Miami, Florida, 33185, United States

Location

Palm Springs Community Health Center

Miami Lakes, Florida, 33014, United States

Location

Quality Research of South Florida

Miami Lakes, Florida, 33016, United States

Location

Oceane7 Medical & Research Center, Inc.

Miami Lakes, Florida, 33144, United States

Location

Combined Research Orlando Phase I-IV LLC

Orlando, Florida, 32807, United States

Location

Global Clinical Professionals

St. Petersburg, Florida, 33705, United States

Location

Balanced Life Health Care Solutions

Lawrenceville, Georgia, 30046, United States

Location

PanAmerican Clincal Research

Brownsville, Texas, 78520, United States

Location

Alina Clinical Trials LLC

Dallas, Texas, 75209, United States

Location

Care United Research, LLC

Forney, Texas, 75126, United States

Location

Clinical Research Partners LLC

Richmond, Virginia, 23226, United States

Location

Frontier Clinical Research LLC

Kingwood, West Virginia, 26537, United States

Location

Japanese Site 10

Multiple Locations, Japan

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Japanese Site 11

Multiple Locations, Japan

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Japanese Site 12

Multiple Locations, Japan

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Japanese Site 13

Multiple Locations, Japan

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Japanese Site 14

Multiple Locations, Japan

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Japanese Site 15

Multiple Locations, Japan

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Japanese Site 16

Multiple Locations, Japan

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Japanese Site 17

Multiple Locations, Japan

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Japanese Site 18

Multiple Locations, Japan

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Japanese Site 19

Multiple Locations, Japan

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Japanese Site 1

Multiple Locations, Japan

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Japanese Site 20

Multiple Locations, Japan

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Japanese Site 21

Multiple Locations, Japan

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Japanese Site 22

Multiple Locations, Japan

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Japanese Site 23

Multiple Locations, Japan

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Japanese Site 24

Multiple Locations, Japan

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Japanese Site 25

Multiple Locations, Japan

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Japanese Site 26

Multiple Locations, Japan

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Japanese Site 27

Multiple Locations, Japan

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Japanese Site 28

Multiple Locations, Japan

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Japanese Site 29

Multiple Locations, Japan

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Japanese Site 2

Multiple Locations, Japan

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Japanese Site 30

Multiple Locations, Japan

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Japanese Site 31

Multiple Locations, Japan

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Japanese Site 32

Multiple Locations, Japan

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Japanese Site 33

Multiple Locations, Japan

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Japanese Site 34

Multiple Locations, Japan

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Japanese Site 35

Multiple Locations, Japan

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Japanese Site 36

Multiple Locations, Japan

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Japanese Site 3

Multiple Locations, Japan

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Japanese Site 4

Multiple Locations, Japan

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Japanese Site 5

Multiple Locations, Japan

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Japanese Site 6

Multiple Locations, Japan

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Japanese Site 7

Multiple Locations, Japan

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Japanese Site 8

Multiple Locations, Japan

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Japanese Site 9

Multiple Locations, Japan

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2025
• First Posted: April 15, 2025
• Study Start: June 6, 2025
• Primary Completion: September 22, 2025
• Study Completion: September 22, 2025
• Last Updated: September 30, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

JP (36); US (21)