Study to Assess the Efficacy and Safety of Ruxolitinib in Patients With COVID-19 Associated Cytokine Storm

Completed · Phase 3 · Has a placebo group

Conditions studied: Cytokine Storm (Covid-19)

In brief

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 therapy, in patients aged ≥12 years with COVID-19 disease.

Key facts

Study ID

NCT04362137

Run by

Novartis Pharmaceuticals

People needed

432

Starts

2020-05-02

Expected to finish

2020-10-17

Last updated by the study team

2021-10-11

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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

Where it is running

• Novartis Investigative Site — Aurora, Colorado, United States
• Novartis Investigative Site — Denver, Colorado, United States
• Novartis Investigative Site — Atlanta, Georgia, United States
• Novartis Investigative Site — Idaho Falls, Idaho, United States
• Novartis Investigative Site — Ann Arbor, Michigan, United States
• Novartis Investigative Site — Newark, New Jersey, United States
• Novartis Investigative Site — The Bronx, New York, United States
• Novartis Investigative Site — Mesquite, Texas, United States
• Novartis Investigative Site — Seattle, Washington, United States
• Novartis Investigative Site — Madison, Wisconsin, United States
• Novartis Investigative Site — C A B A, Buenos Aires, Argentina
• Novartis Investigative Site — Buenos Aires, Argentina
• Novartis Investigative Site — Buenos Aires, Argentina
• Novartis Investigative Site — Rio de Janeiro, Rio de Janeiro, Brazil
• Novartis Investigative Site — Blumenau, Santa Catarina, Brazil
• Novartis Investigative Site — Barretos, São Paulo, Brazil
• Novartis Investigative Site — São Paulo, São Paulo, Brazil
• Novartis Investigative Site — São Paulo, São Paulo, Brazil
• Novartis Investigative Site — Sorocaba, São Paulo, Brazil
• Novartis Investigative Site — Rionegro, Antioquia, Colombia
• Novartis Investigative Site — Barranquilla, Atlántico, Colombia
• Novartis Investigative Site — Barranquilla, Colombia
• Novartis Investigative Site — Colombes, France
• Novartis Investigative Site — Eaubonne, France
• Novartis Investigative Site — Fullerton, California, United States

Full record on ClinicalTrials.gov

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