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.
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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.
- 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,
oxygen saturation measured while on standard home oxygen supplementation level must
be ≥ 92%.
- Capable and willing to complete an electronic participant diary.
- Contraceptive use by male or female participants should be consistent with local
regulations regarding the use of contraceptive methods for those participating in
clinical studies.
- 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 creatinine clearance < 30
milliliters/minute by Cockcroft Gault 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 ≥ 2.5 × 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.
- 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.
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Shionogi Clinical Trials Administrator Clinical Support Help Line
1-800-849-9707
Shionogiclintrials-admin@shionogi.co.jp
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