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

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.


Eligibility Criteria:
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.