Ruxolitinib for Acute Respiratory Disorder Syndrome Due to COVID-19

  • STATUS
    Recruiting
  • participants needed
    200
  • sponsor
    Vanderson Geraldo Rocha
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Updated on 16 February 2024
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pao2
FIO2
heart failure
pneumonia
immunosuppressive agents
respiratory distress
respiratory disorder
covid-19
SARS
ruxolitinib
acute respiratory distress
fraction of inspired oxygen (fio2)
acute respiratory syndrome (sars)

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.

Details
Condition Severe Acute Respiratory Syndrome Coronavirus 2, SARS-CoV2
Age 18years - 95years
Treatment Placebo, Janus Kinase Inhibitor (ruxolitinib)
Clinical Study IdentifierNCT04477993
SponsorVanderson Geraldo Rocha
Last Modified on16 February 2024

Eligibility

 Yes No Not Sure

Inclusion Criteria

Patients hospitalized with SARS-CoV-2 pneumonia confirmed by RT-PCR or serology (IgA)
PaO2/FiO2 < 300 (not fully explained by heart failure or volume overload) or SpO2 < 90% on room air

Exclusion Criteria

Symptom onset > 14 days
Neutrophil count < 1,000/mm3
Platelets < 50,000/mm3
ICU care at enrollment
On invasive mechanical ventilation at enrollment
Current use of experimental therapy for COVID-19 (except: azithromycin or corticosteroids)
Uncontrolled arterial hypertension
Current or previous use of systemic immunosuppressive therapy in the last 30 days
Pregnancy or lactation
Estimated creatinine clearance < 30 mL/min or receiving CRRT or intermittent hemodialysis
Allergy to ruxolitinib
Active tuberculosis
HIV seropositivity
Prior history of progressive multifocal leukoencephalopathy
Use of any JAK inhibitor in the last 30 days before study enrollment
Not qualifying according to investigators' perception
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pao2
FIO2
heart failure
pneumonia
immunosuppressive agents
respiratory distress
respiratory disorder
covid-19
SARS
ruxolitinib
acute respiratory distress
fraction of inspired oxygen (fio2)
acute respiratory syndrome (sars)

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