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Ruxolitinib in severe COVID-19: Results of a multicenter, prospective, single arm, open-label clinical study to investigate the efficacy and safety of ruxolitinib in patients with COVID-19 and severe acute respiratory syndrome

Authors :
Iastrebner M
Castro J
García Espina E
Lettieri C
Payaslian S
Cuesta MC
Gutiérrez Fernández P
Mandrile A
Contreras AP
Gervasoni S
Verde G
Galetti C
Minoldo E
Caruso V
Source :
Revista de la Facultad de Ciencias Medicas (Cordoba, Argentina) [Rev Fac Cien Med Univ Nac Cordoba] 2021 Sep 07; Vol. 78 (3), pp. 294-302. Date of Electronic Publication: 2021 Sep 07.
Publication Year :
2021

Abstract

Introduction: COVID-19 morbimortality is mainly associated with development of severe acute respiratory syndrome (SARS), which has been related to an augmented immune response of the host with elevated circulating cytokines.<br />Methods: In this prospective, multicenter, single arm (compared with a historical control), add-on, experimental phase 2 study, ruxolitinib 5 mg BID was added to standard of care in COVID-19 patients. Main objective was to determine efficacy and safety of ruxolitinib in patients with COVID-19-related SARS.<br />Results: Even though we could not show a significant reduction of COVID-19 pneumonia patients requiring intensive care unit admission and mechanical ventilation (primary endpoint), a trend to a lower mortality rate in critical ill patients receiving ruxolitinib was reported. Administered ruxolitinib dose had to be increased according to protocol in 32% of patients, without additional toxicity.<br />Conclusion: Side effects profile was manageable, and no direct organ injury was caused by the study drug. Ruxolitinib had a fast anti-inflammatory effect, and one-third of patients felt well immediately after starting treatment.<br /> (Universidad Nacional de Córdoba)

Details

Language :
English
ISSN :
1853-0605
Volume :
78
Issue :
3
Database :
MEDLINE
Journal :
Revista de la Facultad de Ciencias Medicas (Cordoba, Argentina)
Publication Type :
Academic Journal
Accession number :
34617700
Full Text :
https://doi.org/10.31053/1853.0605.v78.n3.32800