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
介入
依頼者(Sponsor)
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