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Ruxolitinib in the Treatment of Covid-19

NCT04414098 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2020-06-04

No results posted yet for this study

Summary

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.

Conditions

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

  • Novartis

    collaborator INDUSTRY

  • Marcelo Iastrebner

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-01
Primary Completion
2020-08-15
Completion
2020-09-15

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04414098 on ClinicalTrials.gov