SARS-CoV-2 感染症の予防のためのアゼラスティン鼻スプレー: ランダム化臨床試験第 2 段階
Thorsten Lehr1, Peter Meiser2, Dominik Selzer1
1Saarland University, Saarbruecken, Germany.
JAMA internal medicine
|September 2, 2025
まとめ
アゼラスティンの鼻スプレーは,臨床試験でSARS-CoV-2感染のリスクを有意に低下させた. この抗ヒスタミンは,ワクチン接種戦略を補完する,COVID-19に対する安全な暴露前予防 (PEP) として有望である.
科学分野:
- ウイルス学
- 感染症
- 薬理学について
背景:
- ワクチン接種以外にも,COVID-19 曝露前予防 (PEP) に限られた薬剤の選択肢があります.
- 既知の抗ヒスタミン鼻スプレーであるアゼラスティンは,SARS-CoV-2に対する in vitro 抗ウイルス活性を示しています.
- この研究は,呼吸器ウイルス感染症に対する予防薬としてのアゼラスティンの可能性を調査しています.
研究 の 目的:
- 健康な成人のSARS-CoV-2感染を予防するためのアゼラスティン鼻スプレーの有効性と安全性を評価する.
- SARS-CoV-2 感染症の発生率と持続時間に対するアゼラスティンの影響を評価する.
- リノウイルスなどの他の呼吸器ウイルス感染症に対するアゼラスティンの効果を調査する.
主な方法:
- 450人の健康な成人を対象に実施された ステージ2のダブルブラインド・プラセボ対照試験です
- 参加者は56日間,アゼラスティン (0. 1%) またはプラセボの鼻スプレーを1日3回投与された.
- SARS-CoV-2 感染は急速抗原検査でモニタリングされ,PCR で確認された.他の呼吸器ウイルスはマルチプレックスPCR で検査された.
主要な成果:
- PCRで確認されたSARS-CoV-2感染の発生率は,プラセボ (6. 7%) と比較してアゼラスティン群では著しく低かった.
- アゼラスティンは感染までの平均時間を (31.2日 vs 19. 5日) 増加させ,症状を伴う感染を減少させた.
- アゼラスティンはPCRで確認されたリノウイルス感染症の発生率も低かった (1. 8% 対 6. 3%) で,グループ間の有害事象は比較可能であった.
結論:
- アゼラスティンの鼻スプレーは,この試験でSARS-CoV-2呼吸器感染症のリスクを低下させた.
- 発見は,アゼラスティンがCOVID-19の予防のための潜在的な安全な予防方法であることを示唆しています.
- これらの有望な結果を確認するために,より大きな多センター試験が必要である.
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