重度のCOVID-19患者におけるレムデシビル:ランダム化,二重盲検,プラセボ対照,多センター試験
Yeming Wang1, Dingyu Zhang2, Guanhua Du3
1Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases, China-Japan Friendship Hospital, Beijing, China; Department of Respiratory Medicine, Capital Medical University, Beijing, China.
Lancet (London, England)
|May 20, 2020
まとめ
レムデシビル (GS-5734) は,中国の試験で重症なCOVID-19患者に対して有意な臨床的効果を示さなかった. 以前の治療は数値的な改善を示し,より大きな研究でさらなる調査を正当化しました.
科学分野:
- 感染症
- 臨床医学
- 薬理学について
背景:
- 2019年の重症コロナウイルス病 (COVID-19) は,抗ウイルス薬が実証されていない.
- レムデシビル (GS-5734) は,ヌクレオシドの類型であり,SARS-CoV-2を含むコロナウイルスに対するインビトロおよびインビボの抗ウイルス活性を示しています.
研究 の 目的:
- 重度のCOVID-19で入院している成人の患者におけるレムデシビルの有効性と安全性を評価する.
- 臨床改善までの時間を決定する.
主な方法:
- ランダム化,ダブルブラインド,プラセボ制御,多センター試験が中国湖北で行われました.
- 重度のCOVID-19患者237人をランダムに (2:1) 静脈内レムデシビルまたはプラセボを10日間投与した.
- 主要評価項目は28日以内に臨床改善までの時間でした.
主要な成果:
- レムデシビル治療は,プラセボと比較して臨床改善までの時間における統計的に有意な差に関連しませんでした (HR 1. 23 [95% CI 0. 87-1.75]).
- 症状の持続期間は10日以下であった (HR1. 52 [0. 95~2. 43]).
- レムデシビル投与を受けた患者の12%で,プラセボ投与を受けた患者の5%で早期中止に至った.
結論:
- この試験では,レムデシビルが重症のCOVID-19患者に対して統計的に有意な臨床効果を示さなかった.
- 早期治療を受けた患者で観察された数値的な利益は,より大きな試験でのさらなる調査が必要であることを示唆しています.
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