Ruxolitinib for Acute Respiratory Disorder Syndrome Due to COVID-19 (RUXO-COVID)

Vanderson Geraldo Rocha

Status and phase: Terminated; Phase 3; Phase 2

Conditions: SARS-CoV2; Severe Acute Respiratory Syndrome Coronavirus 2

Treatments: Drug: Janus Kinase Inhibitor (ruxolitinib); Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT04477993

32894720.3.0000.0068

Details and patient eligibility

About

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.

Enrollment: 5 patients

Sex: All

Ages: 18 to 95 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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5 participants in 2 patient groups, including a placebo group

Experimental Group - ruxolitinib

Experimental group

Description:

Ruxolitinib 5 mg PO b.i.d. for 14 days

Treatment:

Drug: Janus Kinase Inhibitor (ruxolitinib)

Placebo Group

Placebo Comparator group

Treatment:

Other: Placebo