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Purpose

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.

Condition

Eligibility

Eligible Ages
Between 18 Years and 64 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

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.

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Triple (Participant, Care Provider, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
S-892216: Dose 1 		Participants will receive S-892216.
  • Drug: S-892216
    S-892216 will be administered orally as a tablet.
  • Drug: Placebo
    Placebo will be administered orally as a tablet.
Experimental
S-892216: Dose 2 		Participants will receive S-892216.
  • Drug: S-892216
    S-892216 will be administered orally as a tablet.
Experimental
S-892216: Dose 3 		Participants will receive S-892216.
  • Drug: S-892216
    S-892216 will be administered orally as a tablet.
Placebo Comparator
Placebo 		Participants will receive placebo.
  • Drug: Placebo
    Placebo will be administered orally as a tablet.

Recruiting Locations

More Details

NCT ID
NCT06928051
Status
Recruiting
Sponsor
Shionogi

Study Contact

Shionogi Clinical Trials Administrator Clinical Support Help Line
1-800-849-9707
Shionogiclintrials-admin@shionogi.co.jp

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.