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.
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 enrolled patients to ruxolitinib or placebo, in addition to standard of
care (SoC) per local practice. Patients who meet the inclusion/exclusion criteria were
randomized in a 2:1 ratio to either oral ruxolitinib 5 mg twice daily + SoC or oral
matching-image placebo + SoC for a total of 14 days. An additional 14 days of study drug
could be given if in the opinion of the investigator the patient's clinical signs and
symptoms did not improve, or worsen, and the potential benefit outweighed the potential risk.
The study included:
- Screening period of 0-2 days.
- Study period of 29 days (treatment of 14 days with possible extension of treatment to 28
days).
The primary objective was to evaluate the efficacy (as measured by a composite endpoint of
proportion of patients who die, develop respiratory failure [require mechanical ventilation],
or require intensive care unit care) of ruxolitinib + standard-of-care (SoC) therapy compared
with placebo + SoC therapy, for the treatment of COVID-19 by Day 29.
Drug: Ruxolitinib
Ruxolitinib 5 mg tablets
Other Name: INC424
Drug: Placebo
Matching-image placebo
Inclusion Criteria:
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 Criteria:
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
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Novartis Pharmaceuticals, Study Director
Novartis Pharmaceuticals