The primary objective of this study is to investigate the antiviral effect of S-892216 inparticipants with coronavirus disease 2019 (COVID-19) due to severe acute respiratorysyndrome coronavirus 2 (SARS-CoV-2) infection.
Not Provided
Drug: S-892216
S-892216 will be administered orally as a tablet.
Drug: Placebo
Placebo will be administered orally as a tablet.
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.
Healthstar Research
Hot Springs	4115412, Arkansas	4099753, United States
Invictus Clinical Research Group LLC
Coconut Creek	4151455, Florida	4155751, United States
Hope Clinical Trials
Coral Gables	4151871, Florida	4155751, United States
Advanced Research for Health Improvement LLC
Immokalee	4159553, Florida	4155751, United States
LCC Medical Research
Miami	4164138, Florida	4155751, United States
CCM Clinical Research Group
Miami	4164138, Florida	4155751, United States
Global Health Clinical Trials
Miami	4164138, Florida	4155751, United States
Continental Clinical Research
Miami	4164138, Florida	4155751, United States
Entrust Clinical Research
Miami	4164138, Florida	4155751, United States
Kendall South Medical Center Inc
Miami	4164138, Florida	4155751, United States
Palm Springs Community Health Center
Miami Lakes	4164186, Florida	4155751, United States
Quality Research of South Florida
Miami Lakes	4164186, Florida	4155751, United States
Oceane7 Medical & Research Center, Inc.
Miami Lakes	4164186, Florida	4155751, United States
Combined Research Orlando Phase I-IV LLC
Orlando	4167147, Florida	4155751, United States
Global Clinical Professionals
St. Petersburg	4171563, Florida	4155751, United States
Balanced Life Health Care Solutions
Lawrenceville	4205196, Georgia	4197000, United States
PanAmerican Clincal Research
Brownsville	4676740, Texas	4736286, United States
Alina Clinical Trials LLC
Dallas	4684888, Texas	4736286, United States
Care United Research, LLC
Forney	4691833, Texas	4736286, United States
Clinical Research Partners LLC
Richmond	4781708, Virginia	6254928, United States
Frontier Clinical Research LLC
Kingwood	4811007, West Virginia	4826850, United States
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Japanese Site 1
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Japanese Site 5
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Japanese Site 7
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Japanese Site 8
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Japanese Site 9
Multiple Locations, Japan
Not Provided