Trial NCT04362137; EudraCT 2020-001662-11
Publication RUXCOVID - Han MK, Lancet Rheumatol (2022) (published paper)
Dates: 2020-05-04 to 2020-09-19
Funding: Private (Novartis and Incyte)
Conflict of interest: Yes
Methods | |
RCT Blinding: double blinding | |
Location :
Multicenter / Russia, USA, Brazil, Spain,
Argentina, Peru, Turkey, Mexico, UK, Colombia, France,
and Germany Follow-up duration (days): 29 | |
Inclusion criteria |
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Exclusion criteria |
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Interventions | |
Treatment
Ruxolitinib 5 mg tablets orally twice daily for 14 days with possible extension of treatment to 28 days |
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Control
Placebo | |
Participants | |
Randomized participants : Placebo=145 Ruxolitinib=287 | |
Characteristics of participants N= 432 Mean age : NR 235 males Severity : Mild: n=141 / Moderate: n=268 / Severe: n=22 Critical: n=0 Number of vaccinated participants: 0 | |
Primary outcome | |
In the register Proportion of Patients Who Die, Develop Respiratory Failure [Require Mechanical Ventilation] or Require Intensive Care Unit (ICU) Care [ Time Frame: Day 1 - Day 29 ] | |
In the report Composite of death, respiratory failure (requiring invasive mechanical ventilation), or ICU care, by day 29 | |
Documents available |
Protocol Yes. In English Statistical plan Yes Data-sharing willing stated in the publication: Yes |
Risk of bias Overall The overall risk of bias reported in the table corresponds to the highest risk of bias for the outcomes assessed for the systematic review |
Some concerns |
General comment |
In addition to the trial registry, the study protocol, statistical analysis plan, results summary and clinical trial report were used in data extraction and assessment of risk of bias. No pre-print or published article was available. The study achieved the target sample size specified in the trial registry. There is no change from the trial registration in the intervention and control treatments. Immunosuppressants were not allowed as part of eligibility criteria but 58% of participants received steroids at baseline. The primary outcome indicated in registry reflects the primary outcome reported in the trial results summaries. The trial (n = 432) achieved the anticipated sample size in the original version of the registry (n = 402). Adverse and serious adverse events were not described in the registry but are reported in the protocol.
This study was updated on May 11th, 2022 with data extracted from the published peer-reviewed report. |