COMPLETED

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

Conditions

COVID-19 S-892216 Mpro Main Protease Nonstructural Protein 5 nsp5 Protease Inhibitor

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-06-06

Study Completion:2025-09-22

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT06928051

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 64 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Study Locations (Sites)

Healthstar Research

Hot Springs, Arkansas, 71913

United States

Invictus Clinical Research Group LLC

Coconut Creek, Florida, 33073

United States

Hope Clinical Trials

Coral Gables, Florida, 33134

United States

Advanced Research for Health Improvement LLC

Immokalee, Florida, 34142

United States

LCC Medical Research

Miami, Florida, 33126

United States

CCM Clinical Research Group

Miami, Florida, 33133

United States

Global Health Clinical Trials

Miami, Florida, 33135

United States

Continental Clinical Research

Miami, Florida, 33144

United States

Entrust Clinical Research

Miami, Florida, 33176

United States

Kendall South Medical Center Inc

Miami, Florida, 33185

United States

Palm Springs Community Health Center

Miami Lakes, Florida, 33014

United States

Quality Research of South Florida

Miami Lakes, Florida, 33016

United States

Oceane7 Medical & Research Center, Inc.

Miami Lakes, Florida, 33144

United States

Combined Research Orlando Phase I-IV LLC

Orlando, Florida, 32807

United States

Global Clinical Professionals

St. Petersburg, Florida, 33705

United States

Balanced Life Health Care Solutions

Lawrenceville, Georgia, 30046

United States

PanAmerican Clincal Research

Brownsville, Texas, 78520

United States

Alina Clinical Trials LLC

Dallas, Texas, 75209

United States

Care United Research, LLC

Forney, Texas, 75126

United States

Clinical Research Partners LLC

Richmond, Virginia, 23226

United States

Frontier Clinical Research LLC

Kingwood, West Virginia, 26537

United States

Collaborators and Investigators

Sponsor: Shionogi

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-06-06

Study Completion Date2025-09-22

Study Record Updates

Study Start Date2025-06-06

Study Completion Date2025-09-22

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

COVID-19