NCT04477993

Ruxolitinib for Acute Respiratory Disorder Syndrome Due to COVID-19

Randomized, Double-Blind Clinical Trial of Ruxolitinib in Patients With Acute Respiratory Disorder Syndrome Due to SARS-CoV-2 Infection

• Status: Terminated
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: Vanderson Geraldo Rocha · Academic / Other
• Sex: All
• Age: 18 Years – 95 Years
• Healthy volunteers: Not accepted

Summary

The COVID-19 pandemic has had a dramatic effect in public health worldwide. In Brazil, there have been more than 2 million confirmed cases and over 75,000 deaths since February 26, 2020. Based on reports of a hyperinflammatory state associated with COVID-19, the use of immunosuppressive drugs may be efficacious in the treatment of this disease. JAK inhibitors have been shown to harness inflammation in a number of different pathologic conditions. The aim of the present study is to evaluate the efficacy and safety of JAK inhibitor ruxolitinib in patients with acute respiratory distress syndrome due to COVID-19.

Conditions

• Severe Acute Respiratory Syndrome Coronavirus 2
• SARS-CoV2

Interventions

Type	Name	Description
DRUG	Janus Kinase Inhibitor (ruxolitinib)	5 mg P.O. b.i.d. for 14 days. Dose reduction will occur if neutrophils \< 500/mm3 or platelets \<50,000/mm3.
OTHER	Placebo	Placebo tablets P.O. b.i.d. for 14 days.

Timeline

• Start date: 2020-08-14
• Primary completion: 2021-03-29
• Completion: 2021-03-29
• First posted: 2020-07-20
• Last updated: 2021-04-08

Locations

1 site across 1 country: Brazil