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Ruxolitinib in treatment of severe coronavirus disease 2019 (COVID-19): A multicenter, single-blind, randomized controlled trial
Open accessAbstract
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 After exclusion of 2 patients (1 ineligible, 1 consent withdrawn) from the ruxolitinib group, 20 patients in the intervention group and 21 patients in the control group were included in the study.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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“However, ruxolitinib failed to show significant protection in the treatment of severe coronavirus disease (57) and the National Institutes of Health recommends against using ruxolitinib for the treatment of COVID-19 (https://bit.ly/3TtgsIe).”
From DrugCentral 2023 extends human clinical data and integrates veterinary drugs (2023) · cites this paper as [57]
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Metadata
- 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
- 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)
- 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
- 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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