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 After exclusion of 2 patients (1 ineligible, 1 consent withdrawn) from the ruxolitinib group, 20 patients in the intervention group and 21 patients in the control group were included in the study.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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Ruxolitinib failed to show significant protection in the treatment of severe coronavirus disease.
“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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- 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 › 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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