A phase 3 randomized, double-blind, placebo controlled study to evaluate the efficacy and safety of secutrelvir in participants with COVID-19 who are at high risk for progression to severe disease (COVID-19)

未提供0 个研究点目标入组 2,000 人开始时间: 待定

适应症

试验速览

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•Must be 12 to < 18 years of age with a body weight >= 40 kg, or >= 18 years of age regardless of body weight.
•Presence of risk factors for progression to severe COVID-19 at the time of screening.
•Must have >= 1 of the COVID-19 signs/symptoms that is at least mild in severity and must still be present in the 24 hours prior to randomization.
•Confirmed SARS-CoV-2 infection, as determined by any SARS-CoV-2 test, of any respiratory tract specimen, collected <= 72 hours prior to randomization.
•Must be randomized within 72 hours of symptom onset, defined as the time when the first COVID-19 symptom occurs.
•Unable or unwilling to take other locally available COVID-19 antivirals.

•Documented respiratory infection (eg, influenza, respiratory syncytial virus) other than COVID-19 within the 14 days prior to the screening visit.
•Known history of cirrhosis or liver decompensation (including ascites, variceal bleeding, or hepatic encephalopathy).
•Suspected or confirmed COVID-19 unrelated to the current episode within 6 months prior to randomization or, for moderately immunocompromised participants, within 3 months prior to randomization.
•Current severely immunocompromised conditions.

发起方

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