Ruxolitinib for Acute Respiratory Disorder Syndrome Due to COVID-19

Conditions

• SARS-CoV2
• Severe Acute Respiratory Syndrome Coronavirus 2

Eligibility Criteria

Sex

ALL

Age

18 Years - 95 Years

Healthy Volunteers

Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date

Aug 14, 2020

Status verified

Apr 2021

Primary completion

Mar 29, 2021

Completion

Mar 29, 2021

Study Design

Enrollment

5 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Experimental Group - ruxolitinib
  Ruxolitinib 5 mg PO b.i.d. for 14 days
• Placebo Comparator: Placebo Group

Primary Outcome Measure

A composite outcome of death or ICU admission or mechanical ventilation at day 14. [ Time Frame: 14 days ]