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.

Estamos haciendo este estudio para aprender más sobre los efectos del medicamento de estudio (Ruxolitinib) en personas que están actualmente en ventilador (respirador) y que han sido diagnosticados con COVID-19.

What is the Condition Being Studied?

COVID-19 infection needing a ventilator

Infección por COVID-19 en personas con necesidad de ventilador (respirador)

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

Cualquier persona mayor de 12 años de edad y que haya sido diagnosticado con COVID-19, quienes:
- Estén en ventilador (respirador)
- No tengan enfermedad renal
- No tengan otras infecciones

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

Si usted decide participar, usted:
-Será aleatoriamente asignado (al azar, como lanzar una moneda al aire) a 1 de 3 grupos:
-El Grupo 1 recibirá 5mg del medicamento de estudio (Ruxolitinib)
-El Grupo 2 recibirá 15mg del medicamento de estudio (Ruxolitinib)
-El Grupo 3 recibirá placebo (una pastilla de azúcar)
-Acordará estar en el estudio durante 1 mes
-Completará una llamada telefónica de seguimiento 28 días después de haber tomado su última dosis del medicamento

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
Enrollment Status
Open for Enrollment
Participate
Contact the Duke Recruitment Innovation Center
MyResearchPartners@duke.edu
or
919-681-5698