Phase 1

• Conditions: COVID-19 associated cytokine storm; MedDRA version: 23.0Level: LLTClassification code 10053983Term: Corona virus infectionSystem Organ Class: 100000004862; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2020-001662-11-IT
• Lead Sponsor: OVARTIS PHARMA AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-07-03
• Last Update Posted: 18 January 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 402

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 with lung imaging showing pulmonary infiltrates (chest Xray or CT scan) 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).
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 332
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 60

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.
Additional exclusion criteria as per main section in the protocol may apply.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified