Covid-19 Living Data

Trial NCT04377620
Publication RUXCOVID-DEVENT - RUXCOVID-DEVENT, Unpublished (2022) (preprint)

Funding: Private (Incyte Corporation)
Conflict of interest: Yes

Methods
	RCT Blinding: double blinding
	Location : Multicenter / Russia and the USA Follow-up duration (days): 28
Inclusion criteria	Participant or guardian health proxy must provide informed consent before any study assessment is performed Male or female participants aged ≥ 12 years Participants with coronavirus (SARS-CoV-2) infection confirmed ≤ 3 weeks prior to randomization by any test with local regulatory approval Participants who are intubated and receiving mechanical ventilation due to COVID-19-associated ARDS and have a PaO2/FiO2 of ≤ 300 mmHg within 6 -hours of randomization Participants with lung imaging showing bilateral or diffuse pulmonary infiltrates on chest x-ray or CT scan.
Exclusion criteria	Known history of hypersensitivity to any drugs or metabolites of similar chemical classes as ruxolitinib Presence of severely impaired renal function defined by estimated creatinine clearance < 15 mL/min measured or calculated by Cockcroft-Gault equation or calculated by the updated bedside Schwartz equation Participants must not be receiving CRRT or intermittent hemodialysis at screening In the opinion of the investigator, unlikely to survive for > 24 hours from randomization Suspected active uncontrolled bacterial, fungal, viral, or other infection (besides COVID-19) Currently receiving ECMO Participant may not be sharing a ventilator, or co-ventilating, with any other patient Treatment with anti-IL-6, IL-6R, IL-1RA, IL-1β, or GM-CSF antagonists, or a BTK inhibitor, within 7 days of randomization Treatment with a JAK inhibitor within 30 days of randomization Participants who are on long-term use of antirejection or immunomodulatory drugs Pregnant or nursing (lactating) women.
Interventions
	Treatment Ruxolitinib 5mg 5 mg twice a day for 14 days through enteric feeding tube or orally Ruxolitinib 15mg 15 mg twice a day for 14 days through enteric feeding tube or orally
	Control Placebo
Participants
	Randomized participants : Placebo=47 Ruxolitinib 5mg=87 Ruxolitinib 15mg=77
	Characteristics of participants N= 211 Mean age : NR 137 males Severity : Mild: n=0 / Moderate: n=0 / Severe: n=0 Critical: n=211 Number of vaccinated participants: NR
Primary outcome
	In the register Percentage of Participants Who Have Died Due to Any Cause [ Time Frame: Study start to Day 29 ] To evaluate the 28-day mortality rate of ruxolitinib 5 mg BID + SoC therapy and ruxolitinib 15 mg BID + SoC compared with placebo + SoC therapy, in participants with COVID-19-associated ARDS who require mechanical ventilation.
	In the report NR
Documents available	Protocol Yes. In English Statistical plan Yes Data-sharing willing stated in the publication: Not reported
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	Low
General comment	“In addition to the study results posted to ClinicalTrials.gov, the protocol, statistical analysis plan and prospective study registry were used in data extraction and risk of bias assessment. No manuscript was available. There is no change from the trial registration in the intervention and control treatments. The registry primary outcome reflects the reported primary outcome. The eligibility age was changed from ≥18 years to ≥12 years one week after start of recruitment. The study was terminated early by the study sponsor for unknown reasons that were not related to safety. As a result the study (n=211) did not achieve the target sample size (n=500) specified in the trial registry."