開拓藥業-B(09939.HK)新藥臨床數據顯示可持續降低新冠病毒載量
開拓藥業-B(09939.HK)公布,普克魯胺治療輕中症非住院新冠患者III期臨床試驗(NCT04870606)的關鍵數據結果。受試者分別給予口服普克魯胺200mg,一日一次+標準治療(普克魯胺組)或安慰劑+標準治療(對照組),治療周期為持續給藥14天。該臨床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。
相對於對照組,普克魯胺治療組從給藥第3天到第28天,可顯著持續降低新冠病毒載量(第3天及第28天,p﹤0.01)。
症狀改善方面,普克魯胺組較對照組可更好地改善新冠肺炎的部分相關症狀如發熱、氣短、咳嗽,且改善持續優於對照組到至少第28天。
該臨床試驗是一項雙盲、安慰劑對照、隨機(1:1)、全球多中心的註冊性臨床試驗,自去年4月24日開始全球首位受試者入組,於去年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),並於今年2月3日完成最後一名受試者末次訪視。
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