Ruxolitinib in the Treatment of Covid-19

Sponsor
Marcelo Iastrebner
Study ID
NCT04414098
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • INC424 / Ruxolitinib — DRUG
    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.

Study Details

The treatment of COVID-19 severe acute respiratory syndrome with ruxolitinib 5 mg orally every 12 hours during 14 days would stop the disproportionate inflammatory response, causing a reduction in the proportion of patients who show a progression and worsening of the severe acute respiratory syndrome.

Key Dates

Start date
Jun 1, 2020
Status verified
Jun 2020
Primary completion
Aug 15, 2020
Completion
Sep 15, 2020

Study Design

Enrollment
100 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Primary Outcome Measure

Evaluate the efficacy of ruxolitinib in the treatment of COVID-19 severe acute respiratory syndrome [ Time Frame: during 14 days after the commencement of treatment ]

Central Contacts

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