Ruxolitinib in treatment of severe coronavirus disease 2019 (COVID-19): A multicenter, single-blind, randomized controlled trial.
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 After exclusion of 2 patients (1 ineligible, 1 consent withdrawn) from the ruxolitinib group, 20 patients in the intervention group and 21 patients in the control group were included in the study.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.
['Cao|Yang|Y|', 'Wei|Jia|J|', 'Zou|Liang|L|', 'Jiang|Tiebin|T|', 'Wang|Gaoxiang|G|', 'Chen|Liting|L|', 'Huang|Liang|L|', 'Meng|Fankai|F|', 'Huang|Lifang|L|', 'Wang|Na|N|', 'Zhou|Xiaoxi|X|', 'Luo|Hui|H|', 'Mao|Zekai|Z|', 'Chen|Xing|X|', 'Xie|Jungang|J|', 'Liu|Jing|J|', 'Cheng|Hui|H|', 'Zhao|Jianping|J|', 'Huang|Gang|G|', 'Wang|Wei|W|', 'Zhou|Jianfeng|J|']
D000368:Aged D000073640:Betacoronavirus D000086382:COVID-19 D018352:Coronavirus Infections D005260:Female D006801:Humans D000075242:Janus Kinase Inhibitors D008297:Male D008875:Middle Aged D009570:Nitriles D058873:Pandemics D011024:Pneumonia, Viral D011720:Pyrazoles D011743:Pyrimidines D000086402:SARS-CoV-2 D016037:Single-Blind Method D016896:Treatment Outcome
Ruxolitinib COVID-19 randomized controlled trial efficacy safety cytokine storm