Ruxolitinib for Acute Respiratory Disorder Syndrome Due to COVID-19

NCT04477993 | Terminated Phase 2 DMC

• 1 other identifier: 32894720.3.0000.0068
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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

Keywords

SARS-CoV2; Severe Acute Respiratory Syndrome Coronavirus 2; Janus Kinase Inhibitors; Safety; Clinical Efficacy; Clinical Trial

Outcome Measures

Primary Outcomes (1)

• A composite outcome of death or ICU admission or mechanical ventilation at day 14.

  14 days

Secondary Outcomes (45)

• A composite outcome of death or ICU admission or mechanical ventilation at day 28

  28 days

• Time to treatment failure

  28 days

• Overall survival at days 14 and 28

  14 and 28 days

• Cumulative incidence of ICU admission rate at days 14 and 28

  14 and 28 days

• Cumulative incidence of mechanical ventilation at days 14 and 28

  14 and 28 days

Study Arms (2)

Experimental Group - ruxolitinib

EXPERIMENTAL

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

Drug: Janus Kinase Inhibitor (ruxolitinib)

Placebo Group

PLACEBO COMPARATOR

Other: Placebo

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.

Experimental Group - ruxolitinib

Placebo OTHER

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

Placebo Group

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Vanderson Geraldo Rocha: lead

Study Sites (1)

Hospital das Clínicas

São Paulo, 05403-000, Brazil

Location

MeSH Terms

Interventions

Janus Kinase Inhibitors; ruxolitinib

Intervention Hierarchy (Ancestors)

Protein Kinase Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Full Professor

Study Record Dates

• First Submitted: July 13, 2020
• First Posted: July 20, 2020
• Study Start: August 14, 2020
• Primary Completion: March 29, 2021
• Study Completion: March 29, 2021
• Last Updated: April 8, 2021

Record last verified: 2021-04

Locations

BR (1)