PHASE 3 RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTI-CENTER STUDY TO ASSESS THE EFFICACY AND SAFETY OF RUXOLITINIB IN PATIENTS WITH COVID-19 ASSOCIATED CYTOKINE STORM (RUXCOVID)

ovartis Pharma AG.,0 个研究点目标入组 14 人开始时间: 2020年7月22日最近更新: 2023年9月4日

适应症

试验速览

暂无简介。

•1. Signed informed consent.
•2. Male and female patients aged ≥ 12 years.
•3. Patients with coronavirus (SARS-CoV-2) infection confirmed by polymerase chain reaction (PCR) test or another rapid test.
•4. Patient is currently (or will be) hospitalized.
•5. 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

•1. Hypersensitivity to any drugs/metabolites as ruxolitinib.
•2. Presence of severely impaired renal function.
•3. Suspected uncontrolled, active bacterial, fungal, viral, or other infection.
•4. Current or history of active TB infection.
•5. History of progressive multifocal leukoencephalopathy.
•6. Intubated between screening and randomization.
•7. In ICU at time of randomization.
•8. Patients who are on anti-rejection, immunosuppressant or immunomodulatory drugs.
•9. Intubated or in ICU for COVID-19 disease prior to screening.
•10. Participating in any other investigational trials.
•11. Unable to ingest tablets at randomization.
•12. ALT ≥ 5 x ULN at screening.
•13. Evidence of liver cirrhosis (Child A to C).
•14. ANC < 1000/μL at screening.
•15. Platelet count < 50,000/μL at screening.
•16. Pregnant or nursing (lactating) women.
•17. Females of childbearing potential unless the use of highly effective contraception method.

发起方

ovartis Pharma AG.,