a study of s-892216 in participants with covid-19

Conditions: COVID-19

Summary: 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 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.

Keywords: s-892216 3cl protease inhibitor