Study to Assess the Efficacy and Safety of Ruxolitinib in Patients With COVID-19 Associated Cytokine Storm
Summary
Linked Publications
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Ruxolitinib in addition to standard of care for the treatment of patients admitted to hospital with COVID-19 (RUXCOVID): a randomised, double-blind, placebo-controlled, phase 3 trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Patients Who Die, Develop Respiratory Failure [Require Mechanical Ventilation] or Require Intensive Care Unit (ICU) Care |
34; 17 | 0.769 |
| SECONDARY Clinical Status |
3.7; 3.7; 1.8; 1.8; 1.1; 1.0 | — |
| SECONDARY Percentage of Patients With at Least Two-point Improvement From Baseline in Clinical Status |
206; 108; 252; 129 | 0.647 |
| SECONDARY Percentage of Patients With at Least One-point Improvement From Baseline in Clinical Status |
250; 128; 261; 136 | 0.946 |
| SECONDARY Percentage of Patients With at Least One-point Deterioration From Baseline in Clinical Status |
16; 9; 14; 5 | 0.532 |
| SECONDARY Time to Improvement in Clinical Status |
9.0; 9.0 | 0.330 |
| SECONDARY Mean Change From Baseline in the Clinical Status |
-1.96; -1.93; -2.61; -2.69 | 0.831 |
| SECONDARY Mortality Rate |
6; 2; 9; 3 | 0.944 |
| SECONDARY Proportion of Patients Requiring Mechanical Ventilation |
22; 10 | 0.987 |
| SECONDARY Duration of Hospitalization |
9.0; 9.0 | 0.738 |
| SECONDARY Time to Hospital Discharge or to a NEWS2 Score of ≤2 |
4.0; 4.0 | 0.869 |
| SECONDARY Change From Baseline in NEWS2 Score |
-0.7; -0.6; -1.0; -0.8; -1.3; -1.3 | — |
| SECONDARY Change From Baseline in SpO2/FiO2 Ratio |
90.110; 106.766; 105.553; 109.710 | — |
| SECONDARY Proportion of Patients With no Oxygen Therapy |
255; 133; 262; 136 | 0.325 |
Eligibility Criteria
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) 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
Data sourced from ClinicalTrials.gov (NCT04362137) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.