開拓藥業-B(09939.HK):普克魯胺治療輕中症非住院新冠患者III期臨試關鍵數據結果
格隆匯4月6日丨開拓藥業-B(09939.HK)宣佈普克魯胺治療輕中症非住院新冠患者III期臨牀試驗(NCT04870606)的關鍵數據結果。該臨牀試驗是一項雙盲、安慰劑對照、隨機(1:1)、全球多中心的註冊性臨牀試驗,自2021年4月24日開始全球首位受試者入組,於2021年12月24日完成全球733名受試者入組(其中727名來自美國,其餘來自其他國家),並於2022年2月3日完成最後一名受試者末次訪視。受試者分別給予口服普克魯胺200mg,一日一次+標準治療或安慰劑+標準治療,治療週期為持續給藥14天。該臨牀試驗入組的受試者首次出現新冠症狀不超過五天,無論是否伴有風險因素,以及不排除接種過新冠疫苗的受試者入組。
該臨牀試驗的研究終點為截至第28天未發生住院≥24小時或因外周血氧飽和度(SpO2)≤93%而吸氧≥24小時或死亡的受試者百分比;28天內受試者住院或因外周血氧飽和度≤93%導致吸氧≥24小時或死亡的發生率;基線至第28天病毒載量變化以及安全性評估等。該臨牀試驗結果的主要數據包括普克魯胺可有效降低住院╱死亡率、普克魯胺在伴有高風險因素的受試者中(特別是中高年齡組),能顯著降低住院╱死亡率、普克魯胺可顯著持續降低新冠病毒載量、以及普克魯胺可改善新冠相關症狀。
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