Incyte: COVID PH3 Ruxolitinib in patients with COVID-19 ARDS requiring Ventilation - Clinical Trial

What is the Purpose of this Study?

We are doing this study to learn more about how the study drug (Ruxolitinib) effects people that are on a ventilator and have been infected with COVID-19.

What is the Condition Being Studied?

COVID-19 infection needing a ventilator

Who Can Participate in the Study?

Anyone over age 12 diagnosed with COVID-19 who
- Are on a ventilator
- Do not have kidney disease
- Do not have any other infections

Age Group
Adults

What is Involved?

If you choose to join this study you will:
-Be randomized (like drawing numbers out of a hat) to 1 of 3 groups:
--Group 1 will get 5mg of the study drug (Ruxolitinib)
--Group 2 will get 15mg of the study drug (Ruxolitinib)
--Group 3 will get a placebo (harmless sugar pill)
-Agree to join the study for 1 month
-Complete a follow-up phone call 28 days after taking your last dose of medicine

*If you leave the hospital, you will receive a phone call on days 15 and 29

Study Details

Full Title
Incyte - A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Assess the Efficacy and Safety of Ruxolitinib in Participants With COVID-19 Associated ARDS Who Require Mechanical Ventilation (RUXCOVID-DEVENT)
Principal Investigator
Cell Therapy and Hematologic Malignancies Specialist
Protocol Number
IRB: PRO00105584
NCT: NCT04377620
Phase
Phase III
ClinicalTrials.gov
Contact the Duke Recruitment Innovation Center
MyResearchPartners@duke.edu
or
919-681-5698