Status:
COMPLETED
Study to Assess the Efficacy and Safety of Ruxolitinib in Patients With COVID-19 Associated Cytokine Storm
Lead Sponsor:
Novartis Pharmaceuticals
Collaborating Sponsors:
Incyte Corporation
Conditions:
Cytokine Storm (Covid-19)
Eligibility:
All Genders
12+ years
Phase:
PHASE3
Brief Summary
This was a randomized, double-blind, placebo-controlled, 29-day, multicenter study to assess the efficacy and safety of ruxolitinib + standard-of-care (SoC) therapy, compared with placebo + SoC therap...
Detailed Description
This was a Phase III, multicenter, double-blind, randomized, placebo-controlled study to assess the efficacy and safety of ruxolitinib in patients aged ≥12 years with COVID-19 disease. The study enrol...
Eligibility Criteria
Inclusion
- Patient or guardian/health proxy must provide informed consent (and assent if applicable) before any study assessment is performed.
- Male and female patients aged ≥ 12 years (or ≥ the lower age limit allowed by Health Authority and/or Ethics Committee/Institutional Review Board approvals).
- Patients with coronavirus (SARS-CoV-2) infection confirmed by polymerase chain reaction (PCR) test or another rapid test from the respiratory tract prior to randomization.
- Patients currently hospitalized or will be hospitalized prior to randomization.
- Patients, who meet at least one of the below criteria:
- Pulmonary infiltrates (chest X ray or chest CT scan);
- Respiratory frequency ≥ 30/min;
- Requiring supplemental oxygen;
- Oxygen saturation ≤ 94% on room air;
- Arterial oxygen partial pressure (PaO2)/ fraction of inspired oxygen (FiO2) \< 300mmHg (1mmHg=0.133kPa) (corrective formulation should be used for higher altitude regions (over 1000m).
Exclusion
- History of hypersensitivity to any drugs or metabolites of similar chemical classes as ruxolitinib.
- Presence of severely impaired renal function defined by serum creatinine \> 2 mg/dL (\>176.8 μmol/L), or have estimated creatinine clearance \< 30 ml/min measured or calculated by Cockroft Gault equation or calculated by the updated bedside Schwartz equation.
- Suspected uncontrolled bacterial, fungal, viral, or other infection (besides COVID-19).
- Currently intubated or intubated between screening and randomization. In intensive care unit (ICU) at time of randomization. Intubated or in ICU for COVID-19 disease prior to screening. Patients who are on anti-rejection, immunosuppressant or immunomodulatory drugs (i.e. tocilizumab, ruxolitinib, canakinumab, sarilumab, anakinra).
- Unable to ingest tablets at randomization. Pregnant or nursing (lactating) women
Key Trial Info
Start Date :
May 2 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 17 2020
Estimated Enrollment :
432 Patients enrolled
Trial Details
Trial ID
NCT04362137
Start Date
May 2 2020
End Date
October 17 2020
Last Update
October 11 2021
Active Locations (61)
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1
Novartis Investigative Site
Fullerton, California, United States, 92835
2
Novartis Investigative Site
Aurora, Colorado, United States, 80045
3
Novartis Investigative Site
Denver, Colorado, United States, 80205
4
Novartis Investigative Site
Atlanta, Georgia, United States, 30312