NCT04361903

Ruxolitinib for the Treatment of Acute Respiratory Distress Syndrome in Patients With COVID-19 Infection

COVID-19: Ruxolitinib for the Treatment of cytokinE Storm resPiratory dIstREss Syndrome. RESPIRE Study

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 13 (estimated)
• Sponsor: Azienda USL Toscana Nord Ovest · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

It is an observational, cohort, retrospective, monocentric, non-profit study. The primary objective is to evaluate the efficacy and safety of ruxolitinib in acute respiratory distress syndrome in patients with SARS-CoV-2 COVID-19 with rapid deterioration of respiratory parameters in the last 12 hours.

Detailed description

It is an observational, cohort, retrospective, monocentric, non-profit study. Patients with SARS-CoV-2 COVID-19 pneumonia who started off-label Ruxolitinib treatment in the period between 25/03/2020 and 07/04/2020 in hospitalization in the COVID-19 wards of the USL Toscana Nord Ovest company. Primary objective \- Evaluation of the efficacy and safety of ruxolitinib in acute respiratory distress syndrome in patients with SARS-CoV-2 COVID-19 with rapid deterioration of respiratory parameters in the last 12 hours. Secondary objectives * Improvement of respiratory performance. * Improvement of acute phase inflammation indices. * Evaluation of known adverse events related to the use of the drug. * Evaluation of the epidemiological parameters in COVID-19 patients. * Monitoring of plasma levels of cytokines before and after treatment. Exploratory objectives * Analysis of the outcomes for the launch of a study on the efficacy and safety of Ruxolitinib in the treatment of ADRS in COVID-19 patients.

Conditions

• Severe Acute Respiratory Syndrome Coronavirus 2

Interventions

Type	Name	Description
DRUG	Ruxolitinib Oral Tablet	Ruxolitinib Oral Tablet dosage of at least 20 mg x 2 / day in the first 48 hours

Timeline

• Start date: 2020-04-25
• Primary completion: 2020-05-24
• Completion: 2020-05-31
• First posted: 2020-04-24
• Last updated: 2020-04-24