Front line treatment with Ruxolitinib in stage II/III Covid-19 patients with defined Hyperinflammation - RuxCoFlam

Friedrich-Schiller-Universität Jena0 个研究点目标入组 200 人开始时间: 2020年4月16日最近更新: 2021年7月26日

适应症

试验速览

暂无简介。

•1. Patient or guardian must provide written informed consent (and assent if applicable) before any study assessment is performed.
•2. Male and female patients aged = 18 years.
•3. Patients with temperature > 37.3°C
•4. Patients with respiratory symptoms and/or hypoxia SpO2 < 93%
•5. Patients with Covid-19 stage II and stage III
•6. Patients with lung imaging showing bi-pulmonary infiltrates (chest X-ray or CT scan).
•7. Patients, with a Covid Inflammation Score = 10
•Are the trial subjects under 18? no
•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 50
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 150

•1. History of hypersensitivity to any drugs or metabolites of similar chemical classes as ruxolitinib.
•2. Uncontrolled active bacterial, fungal, viral, or other infection (besides COVID-19).
•3. Active Tuberculosis infection.
•4. Known Positivity for HBV, HCV or HIV.
•5. Patients who are on long-term use of oral anti-rejection or immunomodulatory drugs 1.
•6. Participating in any other interventional clinical trial for COVID-19 .
•7. Treatment with cytokine-directed agents such as anti-IL6 or anti-IL1R directed antibodies (i.e. tocilizumab, anakinra). Other treatment modalities used in locally adapted SOPs (corticosteroids, chloroquine, hydroxychloroquine, lopinavir-ritonavir) may be given with daily documentation of dose and schedule.
•8. ALT or AST > 5 x ULN detected within 24 hours at screening (according to local laboratory reference ranges).
•9. ANC < 500/µL at screening (according to local laboratory reference ranges).
•10. Platelet count < 50,000/µL at screening (according to local laboratory reference ranges).
•11. Hemoglobin < 6 g/dl (3.73mmol/l )
•13. Pregnant or nursing (lactating) women.
•14. Endstage pre-existing organ failure (cardiac, renal, pulmonary, hepatic, cerebrovascular) with survival probability < 6 months
•15. Endstage malignancy with survival probability < 6 months

发起方