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.
Primary Objective Evaluate the efficacy of ruxolitinib in the treatment of COVID-19 severe acute respiratory syndrome by means of measuring the proportion of patients with clinical worsening (defined by a requirement of FIO2 50% and/or mechanical respiratory assistance) during 14 days after the commencement of treatment. Secondary Objectives 1. Evaluate the median duration of hospitalization. Median duration after 45 days of commencement of treatment. 2. Evaluate the evolution of systemic inflammation parameters. Evaluation at the beginning (baseline), middle and end of the treatment with ruxolitinib of PCR, LDH, ESD, Ferritin and IL-6. 3. Evaluate COVID-19 mortality rate after 45 days of treatment. 4. Evaluate the proportion of the requirement of mechanical ventilation. 5. Evaluate ruxolitinib adverse reactions with a total follow-up of 45 days. 6. Evaluate the proportion of secondary infections during the treatment with ruxolitinib.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
100
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.
Evaluate the efficacy of ruxolitinib in the treatment of COVID-19 severe acute respiratory syndrome
Measuring the proportion of patients with clinical worsening (defined by a requirement of FIO2 \>50% and/or mechanical respiratory assistance)
Time frame: during 14 days after the commencement of treatment
Evaluate the median duration of hospitalization.
Time frame: after 45 days of commencement of treatment.
Evaluate the evolution of systemic inflammation parameters.
Evaluation at the beginning (baseline), middle and end of the treatment with ruxolitinib of PCR, LDH, ESD, Ferritin and IL-6 (if available).
Time frame: after 45 days of commencement of treatment.
Evaluate COVID-19 mortality rate
Time frame: after 45 days of treatment.
Evaluate the proportion of the requirement of mechanical ventilation.
Time frame: with a total follow-up of 45 days
Evaluate ruxolitinib adverse reactions
Time frame: with a total follow-up of 45 days.
Evaluate the proportion of secondary infections during the treatment with ruxolitinib
Time frame: after 45 days of commencement of treatment.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.