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Ruxolitinib in treatment of severe coronavirus disease 2019 (COVID-19): A multicenter, single-blind, randomized controlled trial.

Authors
  • Cao, Yang1
  • Wei, Jia1
  • Zou, Liang2
  • Jiang, Tiebin3
  • Wang, Gaoxiang1
  • Chen, Liting1
  • Huang, Liang1
  • Meng, Fankai1
  • Huang, Lifang1
  • Wang, Na1
  • Zhou, Xiaoxi1
  • Luo, Hui1
  • Mao, Zekai1
  • Chen, Xing1
  • Xie, Jungang4
  • Liu, Jing3
  • Cheng, Hui2
  • Zhao, Jianping4
  • Huang, Gang5
  • Wang, Wei6
  • And 1 more
  • 1 Department of Hematology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China; Clincal Trial and Research Center, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China. , (China)
  • 2 Department of Hematology, Wuhan No. 1 Hospital, Wuhan, China. , (China)
  • 3 Hematology Department of The Third Xiangya Hospital Central South University, Changsha, China. , (China)
  • 4 Department of Respiratory and Critical Care Medicine, Key Laboratory of Pulmonary Diseases of Health Ministry, Key Site of National Clinical Research Center for Respiratory Disease, Tongji Hospital, Tongji Medical College Huazhong University of Science and Technology, Wuhan, China. , (China)
  • 5 Divisions of Pathology and Experimental Hematology and Cancer Biology, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio. Electronic address: [email protected]
  • 6 Department of Neurology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China. Electronic address: [email protected] , (China)
  • 7 Department of Hematology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China; Clincal Trial and Research Center, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China. Electronic address: [email protected] , (China)
Type
Published Article
Journal
The Journal of allergy and clinical immunology
Publication Date
Jul 01, 2020
Volume
146
Issue
1
Identifiers
DOI: 10.1016/j.jaci.2020.05.019
PMID: 32470486
Source
Medline
Keywords
Language
English
License
Unknown

Abstract

Accumulating evidence proposed Janus-associated kinase (JAK) inhibitors as therapeutic targets warranting rapid investigation. This study evaluated the efficacy and safety of ruxolitinib, a JAK1/2 inhibitor, for coronavirus disease 2019. We conducted a prospective, multicenter, single-blind, randomized controlled phase II trial involving patients with severe coronavirus disease 2019. Forty-three patients were randomly assigned (1:1) to receive ruxolitinib plus standard-of-care treatment (22 patients) or placebo based on standard-of-care treatment (21 patients). After exclusion of 2 patients (1 ineligible, 1 consent withdrawn) from the ruxolitinib group, 20 patients in the intervention group and 21 patients in the control group were included in the study. Treatment with ruxolitinib plus standard-of-care was not associated with significantly accelerated clinical improvement in severe patients with coronavirus disease 2019, although ruxolitinib recipients had a numerically faster clinical improvement. Eighteen (90%) patients from the ruxolitinib group showed computed tomography improvement at day 14 compared with 13 (61.9%) patients from the control group (P = .0495). Three patients in the control group died of respiratory failure, with 14.3% overall mortality at day 28; no patients died in the ruxolitinib group. Ruxolitinib was well tolerated with low toxicities and no new safety signals. Levels of 7 cytokines were significantly decreased in the ruxolitinib group in comparison to the control group. Although no statistical difference was observed, ruxolitinib recipients had a numerically faster clinical improvement. Significant chest computed tomography improvement, a faster recovery from lymphopenia, and favorable side-effect profile in the ruxolitinib group were encouraging and informative to future trials to test efficacy of ruxolitinib in a larger population. Copyright © 2020 American Academy of Allergy, Asthma & Immunology. Published by Elsevier Inc. All rights reserved.

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