Ruxolitinib for Acute Respiratory Disorder Syndrome Due to COVID-19

NCT ID: NCT04477993

Last Updated: 2021-04-08

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-08-14
• Study Completion Date: 2021-03-29

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 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Experimental Group - ruxolitinib

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

Group Type: EXPERIMENTAL

Janus Kinase Inhibitor (ruxolitinib)

Intervention Type: 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 Group

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Placebo tablets P.O. b.i.d. for 14 days.

Interventions

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.

Intervention Type: DRUG

Placebo

Placebo tablets P.O. b.i.d. for 14 days.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 95 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vanderson Geraldo Rocha

OTHER

Sponsor Role: lead

Responsible Party

Vanderson Geraldo Rocha

Full Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Hospital das Clínicas

São Paulo, , Brazil

Countries

Brazil

Other Identifiers

32894720.3.0000.0068

Identifier Type: -

Identifier Source: org_study_id