Auxora vs. placebo for the treatment of patients with severe COVID-19 pneumonia: a randomized-controlled clinical trial.
Autor: | Bruen C; Regions Hospital, Health Partners, St. Paul, MN, USA., Al-Saadi M; Houston Methodist Hospital, Houston, TX, USA., Michelson EA; Department of Emergency Medicine, Texas Tech University Health Sciences Center, El Paso, TX, USA., Tanios M; MemorialCare Long Beach Medical Center, Long Beach, CA, USA., Mendoza-Ayala R; Aurora BayCare Medical Center, Green Bay, WI, USA., Miller J; Henry Ford Hospital System, Detroit, MI, USA., Zhang J; Princeton Pharmatech, Princeton, NJ, USA., Stauderman K; CalciMedica, Inc, 505 Coast Blvd. South Suite 307, La Jolla, CA, 92037, USA., Hebbar S; CalciMedica, Inc, 505 Coast Blvd. South Suite 307, La Jolla, CA, 92037, USA. sudarshan@calcimedica.com., Hou PC; Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA. |
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Jazyk: | angličtina |
Zdroj: | Critical care (London, England) [Crit Care] 2022 Apr 08; Vol. 26 (1), pp. 101. Date of Electronic Publication: 2022 Apr 08. |
DOI: | 10.1186/s13054-022-03964-8 |
Abstrakt: | Background: Calcium release-activated calcium (CRAC) channel inhibitors block proinflammatory cytokine release, preserve endothelial integrity and may effectively treat patients with severe COVID-19 pneumonia. Methods: CARDEA was a phase 2, randomized, double-blind, placebo-controlled trial evaluating the addition of Auxora, a CRAC channel inhibitor, to corticosteroids and standard of care in adults with severe COVID-19 pneumonia. Eligible patients were adults with ≥ 1 symptom consistent with COVID-19 infection, a diagnosis of COVID-19 confirmed by laboratory testing using polymerase chain reaction or other assay, and pneumonia documented by chest imaging. Patients were also required to be receiving oxygen therapy using either a high flow or low flow nasal cannula at the time of enrolment and have at the time of enrollment a baseline imputed PaO Results: The pre-specified efficacy set consisted of the 261 patients with a baseline imputed PaO Conclusions: Auxora was safe and well tolerated with strong signals in both time to recovery and all-cause mortality through Day 60 in patients with severe COVID-19 pneumonia. Further studies of Auxora in patients with severe COVID-19 pneumonia are warranted. Trial registration NCT04345614. (© 2022. The Author(s).) |
Databáze: | MEDLINE |
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