作者
Joseph Miller, Charles Bruen, Michael Schnaus, Jeffrey Zhang, Sadia Ali, April Lind, Zachary Stoecker, Kenneth Stauderman, Sudarshan Hebbar
发表日期
2020/12
期刊
Critical Care
卷号
24
页码范围
1-9
出版商
BioMed Central
简介
Background
Calcium release-activated calcium (CRAC) channel inhibitors stabilize the pulmonary endothelium and block proinflammatory cytokine release, potentially mitigating respiratory complications observed in patients with COVID-19. This study aimed to investigate the safety and efficacy of Auxora, a novel, intravenously administered CRAC channel inhibitor, in adults with severe or critical COVID-19 pneumonia.
Methods
A randomized, controlled, open-label study of Auxora was conducted in adults with severe or critical COVID-19 pneumonia. Patients were randomized 2:1 to receive three doses of once-daily Auxora versus standard of care (SOC) alone. The primary objective was to assess the safety and tolerability of Auxora. Following FDA guidance, study enrollment was halted early to allow for transition to a randomized, blinded, placebo-controlled study.
Results
In total, 17 patients with severe and …
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J Miller, C Bruen, M Schnaus, J Zhang, S Ali, A Lind… - Critical Care, 2020