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呼吸器感染症およびウイルス性緊急症に対する戦略と治療(STRIVE):塩野義製薬のプロテアーゼ阻害剤(エンシトレルビル)

基本情報

NCT ID
NCT05605093
ステータス
中止
試験のフェーズ
第3相
試験タイプ
介入
目標被験者数
602
治験依頼者名
University of Minnesota

概要

Treatments are needed to improve outcomes among patients hospitalized for COVID-19, including direct-acting antiviral (DAA) agents to mitigate the pathology driven by ongoing viral replication. This trial will evaluate S-217622 (ensitrelvir), an anti-SARS-CoV2 3C-like protease inhibitor (PI) developed by Shionogi \&; Co. Ltd. The study design is a randomized, placebo-controlled, multi-center international clinical trial that will evaluate the clinical efficacy of ensitrelvir when given in addition to standard of care (SOC) for inpatients with COVID-19. The SOC will be determined by local established guidelines and may include additional DAA (e.g., remdesivir) and immunomodulatory treatment strategies. Certain SOC treatments will be pre-specified prior to randomization.

対象疾患

COVID-19

介入

Shionogi Protease Inhibitor (S-217622)(DRUG)
placebo(DRUG)

実施施設 (3)

国立健康危機管理研究機構国立国際医療センター

Shinjuku-Ku, Tokyo, Japan

藤田医科大学病院

Toyoake, Aichi-ken, Japan

りんくう総合医療センター

Osaka, Japan