Status:
TERMINATED
Ruxolitinib for Acute Respiratory Disorder Syndrome Due to COVID-19
Lead Sponsor:
Vanderson Geraldo Rocha
Conditions:
Severe Acute Respiratory Syndrome Coronavirus 2
SARS-CoV2
Eligibility:
All Genders
18-95 years
Phase:
PHASE2
PHASE3
Brief 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 repo...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 14 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 29 2021
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT04477993
Start Date
August 14 2020
End Date
March 29 2021
Last Update
April 8 2021
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Hospital das Clínicas
São Paulo, Brazil, 05403-000