Cited by 464COVID-19 Clinical Research StudiesSARS-CoV-2 and COVID-19 ResearchLong-Term Effects of COVID-19

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

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Cao, Yang, Wei, Jia, Zou, Liang, Jiang, Tiebin, Wang, Gaoxiang, Chen, Liting, Huang, Liang, Meng, Fankai, Huang, Lifang, Wang, Na, Zhou, Xiaoxi, Luo, Hui, Mao, Zekai, Chen, Xing, Xie, Jungang, Liu, Jing, Cheng, Hui, Zhao, Jianping, Huang, Gang, Wang, Wei, Zhou, Jianfeng·2020·Journal of Allergy and Clinical Immunology

DOI 10.1016/j.jaci.2020.05.019PMC PMC7250105

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Abstract

Background Accumulating evidence proposed Janus-associated kinase (JAK) inhibitors as therapeutic targets warranting rapid investigation.Objective This study evaluated the efficacy and safety of ruxolitinib, a JAK1/2 inhibitor, for coronavirus disease 2019.Methods We conducted a prospective, multicenter, single-blind, randomized controlled phase II trial involving patients with severe coronavirus disease 2019.Results 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 After exclusion of 2 patients (1 ineligible, 1 consent withdrawn) from the ruxolitinib group, 20 patients in the intervention group and 21 patients in the control group were included in the study.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.Conclusions 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.

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Authors: Cao, Y., Wei, J., Zou, L., Jiang, T., Wang, G., Chen, L., Huang, L., Meng, F., Huang, L., Wang, N., Zhou, X., Luo, H., Mao, Z., Chen, X., Xie, J., Liu, J., Cheng, H., Zhao, J., Huang, G., Wang, W., & Zhou, J.
Affiliations: Tongji Hospital (CN)
Wuhan No.1 Hospital (CN)
Third Xiangya Hospital (CN)
Cincinnati Children's Hospital Medical Center (US)
Corresponding author: Huang, Gang
Wang, Wei
Zhou, Jianfeng
ORCID: Cao, Yang
Wei, Jia
Zou, Liang
Wang, Gaoxiang
Chen, Liting
Huang, Liang
Meng, Fankai
Wang, Na
Zhou, Xiaoxi
Luo, Hui
Mao, Zekai
Chen, Xing
Xie, Jungang
Liu, Jing
Cheng, Hui
Zhao, Jianping
Huang, Gang
Wang, Wei
Zhou, Jianfeng
Venue: Journal of Allergy and Clinical Immunology
Publisher: Elsevier BV
Published: 2020-07
Volume: 146
Issue: 1
Pages: 137-146.e3
ISSN: 0091-6749 (ISSN-L)
DOI: 10.1016/j.jaci.2020.05.019
PMC: PMC7250105
OpenAlex: W3030158388
Cited by: 456
References: 38
Citations by year: 2026: 2 · 2025: 9 · 2024: 24 · 2023: 45 · 2022: 95 · 2021: 178 · 2020: 103
FWCI: 14.05
Type: journal article
Language: en
Open access: bronze
doi.org
Licence: www.elsevier.com/tdm/userlicense/1.0/ (tdm)
www.elsevier.com/legal/tdmrep-license (tdm)
Locations: Journal of Allergy and Clinical Immunology (publishedVersion)
PubMed Central (publishedVersion)
PubMed (publishedVersion)
Funders: Emergency Research Project of Tongji Hospital
Emergency Research Project of Tongji Hospital of Huazhong University of Science and Technology (2020kfyXGYJ045)
Emergency Research Project of Hubei province (2020FCA006)
Topics: Health Sciences › Medicine › Infectious Diseases › COVID-19 Clinical Research Studies
Health Sciences › Medicine › Infectious Diseases › SARS-CoV-2 and COVID-19 Research
Health Sciences › Medicine › Clinical Neurology › Long-Term Effects of COVID-19
Keywords: ruxolitinib, COVID-19 pandemic, severe COVID-19, JAK1/2 inhibitor, JAK inhibitors, cytokine levels, mortality, drug safety, antiviral therapy
MeSH terms: Betacoronavirus, Janus Kinase Inhibitors, COVID-19, SARS-CoV-2, COVID-19 Drug Treatment, Aged, Female, Humans, Male, Middle Aged, Nitriles, Pneumonia, Viral, Pyrazoles, Pyrimidines, Single-Blind Method, Treatment Outcome, Coronavirus Infections, Pandemics

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

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