Ruxolitinib in the Treatment of Covid-19

PHASE2UnknownINTERVENTIONAL
Enrollment

100

Participants

Timeline

Start Date

June 1, 2020

Primary Completion Date

August 15, 2020

Study Completion Date

September 15, 2020

Conditions
COVID-19
Interventions
DRUG

INC424 / Ruxolitinib

"1. Ruxolitinib 5 mg orally every 12 hours during 14 days.~2. Total Follow-up time will be of 45 days.~3. The reduction of ruxolitinib dose will be considered in cases of drug-related cytopenias.~4. During hospitalization, clinical and laboratory evolution parameters will be recorded daily in the medical history of the patient and in the data collection table of the study. Upon patient's discharge, a follow-up will be conducted until day +45~5. During hospitalization, adverse events will be monitored daily by means of clinical assessment and laboratory data.~6. After discharge, monitoring of adverse events will continue during the outpatient follow-up.~7. Pro-inflammatory parameters will be assessed at baseline, after one week (day +7) and at the end of treatment (day +14)~8. Ruxolitinib will be associated to the standard of care for COVID-19 of each center.~9. In case of an adverse effect or a need to discontinue the treatment, ruxolitinib should be suspended."

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Novartis

INDUSTRY

lead

Marcelo Iastrebner

OTHER