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Research article
Oksana Vladimirovna Stanevich
Pavlov University
Corresponding Author
ORCiD: https://orcid.org/0000-0002-6894-6121
License:
This work is licensed under a CC BY 4.0 License. Read Full License
Background
Several anti-cytokine therapies were tested in the randomized trials in hospitalized patients with severe acute respiratory syndrome coronavirus 2 infection (COVID-19). Previously, dexamethasone demonstrated the reduction of mortality in hospitalized patients with a respiratory failure. In this matched control study we compared dexamethasone to a Janus kinase inhibitor, ruxolitinib.
Methods
The study included 146 hospitalized patients with COVID-19 and oxygen support requirement. The control group was selected 1:1 from 1355 dexamethasone-treated patients and was matched by 29 clinical and laboratory parameters predicting survival.
Results
Ruxolitinib treatment in the general cohort of patients was associated with equivalent to dexamethasone mortality rate: 9,6% (95% CI 4,6–14,6%) vs 13,0% (95% CI 7,5–18,5%, superiority p = 0.35, non-inferiority p = 0.0137), respectively. Median time to discharge without oxygen support requirement was also not different between these groups: 13 vs. 11 days (p = 0.13). Subgroup analysis without adjustment for multiple comparisons demonstrated reduced mortality in ruxolitnib-treated patients with febrile fever (OR 0.33, 95%CI 0.11-1.00). Except higher incidence of grade 1 thrombocytopenia (37% vs 23%, p = 0.042), ruxolitinib therapy was associated with better safety profile due to reduced rate of severe cardiovascular adverse events (6.8% vs 15%, p = 0.025).
Conclusions
Ruxolitinib may be an alternative anti-cytokine therapy with comparable efficacy in patients with potential risks of steroid administration. Patients with febrile fever at admission may benefit from ruxolitinib administration.
Keywords
COVID-19, SARS-CoV-2, ruxolitinib, dexamethasone, anti-cytokine therapy
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CURRENT STATUS: Published
View the published article at BMC Infectious Diseases.
Version 1
Posted 11 Jun, 2021
Community comments: 2
Editorial decision: Minor revision
On 19 Jul, 2021
Review #2 received
Received 11 Jul, 2021
Review #1 received
Received 04 Jul, 2021
Reviewer #2 agreed
On 20 Jun, 2021
Reviewers invited
Invitations sent on 17 Jun, 2021
Reviewer #1 agreed
On 17 Jun, 2021
Editor assigned
On 10 Jun, 2021
Submission checks complete
On 09 Jun, 2021
Editor invited
On 07 Jun, 2021
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Subject Areas
Infectious Diseases
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A new preprint design is coming!
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See the published version of this preprint at BMC Infectious Diseases.
This is a preprint, a preliminary version of a manuscript that has not completed peer review at a journal. Research Square does not conduct peer review prior to posting preprints. The posting of a preprint on this server should not be interpreted as an endorsement of its validity or suitability for dissemination as established information or for guiding clinical practice.
Learn more about In Review
Research article
Oksana Vladimirovna Stanevich
Pavlov University
Corresponding Author
ORCiD: https://orcid.org/0000-0002-6894-6121
Badges
Prescreen
This manuscript passed our Prescreen assessment
Complete author information
Appropriate declaration statements
Potential risks to human health
Prescreen
Peer Review Timeline
CURRENT STATUS: Published
View the published article at BMC Infectious Diseases.
Version 1
Posted 11 Jun, 2021
Community comments: 2
Editorial decision: Minor revision
On 19 Jul, 2021
Review #2 received
Received 11 Jul, 2021
Review #1 received
Received 04 Jul, 2021
Reviewer #2 agreed
On 20 Jun, 2021
Reviewers invited
Invitations sent on 17 Jun, 2021
Reviewer #1 agreed
On 17 Jun, 2021
Editor assigned
On 10 Jun, 2021
Submission checks complete
On 09 Jun, 2021
Editor invited
On 07 Jun, 2021
Metrics
Comments: 0
PDF Downloads: ...
HTML Views: ...
Subject Areas
Infectious Diseases
License:
This work is licensed under a CC BY 4.0 License. Read Full License
View the published article at BMC Infectious Diseases.
Background
Several anti-cytokine therapies were tested in the randomized trials in hospitalized patients with severe acute respiratory syndrome coronavirus 2 infection (COVID-19). Previously, dexamethasone demonstrated the reduction of mortality in hospitalized patients with a respiratory failure. In this matched control study we compared dexamethasone to a Janus kinase inhibitor, ruxolitinib.
Methods
The study included 146 hospitalized patients with COVID-19 and oxygen support requirement. The control group was selected 1:1 from 1355 dexamethasone-treated patients and was matched by 29 clinical and laboratory parameters predicting survival.
Results
Ruxolitinib treatment in the general cohort of patients was associated with equivalent to dexamethasone mortality rate: 9,6% (95% CI 4,6–14,6%) vs 13,0% (95% CI 7,5–18,5%, superiority p = 0.35, non-inferiority p = 0.0137), respectively. Median time to discharge without oxygen support requirement was also not different between these groups: 13 vs. 11 days (p = 0.13). Subgroup analysis without adjustment for multiple comparisons demonstrated reduced mortality in ruxolitnib-treated patients with febrile fever (OR 0.33, 95%CI 0.11-1.00). Except higher incidence of grade 1 thrombocytopenia (37% vs 23%, p = 0.042), ruxolitinib therapy was associated with better safety profile due to reduced rate of severe cardiovascular adverse events (6.8% vs 15%, p = 0.025).
Conclusions
Ruxolitinib may be an alternative anti-cytokine therapy with comparable efficacy in patients with potential risks of steroid administration. Patients with febrile fever at admission may benefit from ruxolitinib administration.
Figure 1
Figure 2
Figure 3
This is a list of supplementary files associated with this preprint. Click to download.
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