Ruxolitinib in the Treatment of Covid-19

COVID-19 Clinical Trial

Official title: Safety and Efficacy Study of Ruxolitinib in the Treatment of Severe Acute Respiratory Syndrome Due to SARS-COV-2

Status Not yet recruiting

Clinical Trial 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.

Clinical Trial Description

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. ;

Related Conditions & MeSH terms

• COVID-19

• NCT number: NCT04414098
• Study type: Interventional
• Source: Clinica Zabala
• Contact: Marcelo Iastrebner, MD
• Phone: +5491169816300
• Email: miastrebner@gmail.com
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: June 1, 2020
• Completion date: September 15, 2020