開拓藥業-B(09939.HK):普克魯胺治療COVID-19重症患者臨試完成588名受試者入組
格隆匯 2 月 22日丨開拓藥業-B(09939.HK)發佈公吿,2021年2月22日,於巴西普克魯胺治療COVID-19重症患者的臨牀試驗已完成588名患者的入組工作。集團預期將於2021年3月公佈臨牀試驗的數據。
臨牀試驗為普克魯胺治療18歲或以上COVID-19重症男性及女性患者的多中心、隨機、雙盲、安慰劑平行對照研究。本試驗共招募588名(294名男性及294名女性)符合所有資格標準的患者,所有患者均在入院後48小時內入組。臨牀試驗設置男性及女性兩個隊列,每個隊列分為普克魯胺組及對照組兩個組別。患者以1:1的比例隨機分配到各組別。
在普克魯胺組中,患者每日口服一次(QD)300毫克普克魯胺,持續14日。在對照組中,患者每日口服一次(QD)普克魯胺安慰劑。各組別亦正在接受臨牀醫生推薦的標準治療藥物。臨牀試驗的主要終點是在第14日通過COVID-198分等級量表評估的普克魯胺組相對於對照組的有效性。
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