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COVID-19 の入院患者に対する超免疫免疫グロブリン (ITAC): ダブルブラインド,プラセボ対照,第3相,ランダム化試験
Lancet (London, England)
|January 30, 2022
まとめ
高免疫性静脈内免疫グロブリン (hIVIG) は,入院したCOVID-19患者のアウトカムを改善しませんでした. 抗体陽性の患者ではリスクが増加した.
科学分野:
- 免疫学
- 感染症
- 臨床試験
背景:
- 回復したドナーからの高免疫性静脈内免疫グロブリン (hIVIG) の被動免疫療法は,SARS-CoV-2に対する潜在的な治療法である.
- COVID-19 治療における hIVIG のランダム化臨床試験データは限られている.
研究 の 目的:
- 入院したCOVID-19患者でプラセボと比較して,hIVIGの有効性と安全性を評価する.
- 順序的なエンドポイントと複合的な安全対策に基づいて結果を評価する.
主な方法:
- 593人の入院COVID-19患者が参加した国際的,ランダム化,ダブルブラインド,プラセボ対照試験.
- 患者はレムデシビルを含む標準治療と共に,hIVIGまたはプラセボを投与された.
- 7日目で7つのカテゴリーのオーダーナルエンドポイントを用いて測定された主なアウトカム; 7日目と28日の複合アウトカムで安全性が評価された.
主要な成果:
- hIVIGはプラセボと比較して,第7日により有利な結果の確率を有意に改善しませんでした (OR1. 06, p=0. 72).
- 輸液反応は,hIVIGでより一般的であった (18. 6% vs 9. 5%).
- 抗体陽性患者ではリスクが増加し,抗体陰性患者ではリスクが低下した (OR0. 51).
結論:
- SARS-CoV-2 hIVIGは,標準的な治療で,末端臓器不全のない入院COVID-19患者の治療に効果を示さなかった.
- hIVIGの安全性プロファイルは,本来の中和抗体の存在によって異なる可能性があります.
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