Ruxolitinib for treatment of Covid-19 induced lung injury ARDS (RuXoCoil)A single-arm, open-label, proof of concept study

Philipps-Universität Marburg0 个研究点目标入组 15 人开始时间: 2020年4月27日最近更新: 2021年8月2日

适应症

试验速览

暂无简介。

•In order to be eligible to participate in this study, a patient must meet all of the following criteria:
•1.Male or non-pregnant female adult =18 years of age at time of enrollment.
•2.has laboratory-confirmed SARS-CoV-2 infection as determined by PCR or other commercial or public health assay (result of the PCR is not necessary for inclusion, but has to approved latest within 48-72 hours after registration)
•3.Willingness of men and women of childbearing potential to use highly effective contraceptive methods by abstinence or by using at least two contraceptive methods from the date of consent to the end of the study
•4.severe lung disease as defined by following:
•a.Recent intubation
•b.Requirement of invasive ventilation moderate to severe pulmonary oxygen exchange disturbance as defined by (PaO2/FiO2) = 200 mmHg at a PEEP = 5mm H2O
•c.Serum LDH > 283 U/l
•d.Ferritin above normal value
•e.CT-scan: pulmonary infiltration compatible with Covid-19 disease
•5.Patient or patient´s representative must provide written informed consent (and assent if applicable) before any study assessment is performed.
•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 5
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 10

•An individual who meets any of the following criteria will be excluded from participation in this study:
•1. Uncontrolled HIV infection
•2. Active tuberculosis (result of positive tuberculosis infection is not necessary for exclusion, but has to approved later on during patient´s intervention)
•3. Chronic kidney disease requiring dialysis
•4. ALT/AST > 5 times the upper limit of normal.
•5. Pregnancy or breast feeding.
•6. Allergy to study medication
•7. Simultaneous participation in another clinical trial with an experimental treatment

发起方