Status:
COMPLETED
Ruxolitinib for Treatment of Covid-19 Induced Lung Injury ARDS
Lead Sponsor:
Philipps University Marburg
Conditions:
ARDS, Human
COVID
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of ruxolitinib in the treatment of patients with COVID-19 severe pneumonia.
Detailed Description
This clinical trial is an open-label trial of ruxolitinib for the treatment of severe COVID-19 to assess its efficacy and safety. Ruxolitinib (INCB018424 phosphate, INC424, ruxolitinib phosphate) is ...
Eligibility Criteria
Inclusion
- Male or non-pregnant female adult ≥18 years of age at time of enrollment.
- 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)
- 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
- severe lung disease as defined by following:
- Recent intubation
- Requirement of invasive ventilation moderate to severe pulmonary oxygen exchange disturbance as defined by (PaO2/FiO2) ≤ 200 mmHg at a PEEP ≥ 5mm H2O
- Serum LDH \> 283 U/l
- Ferritin above normal value
- CT-scan: pulmonary infiltration compatible with Covid-19 disease
- Patient or patient´s representative must provide written informed consent (and assent if applicable) before any study assessment is performed.
Exclusion
- Uncontrolled HIV infection
- Active tuberculosis (result of positive tuberculosis infection is not necessary for exclusion, but has to approved later on during patient´s intervention)
- Chronic kidney disease requiring dialysis
- ALT/AST \> 5 times the upper limit of normal.
- Pregnancy or breast feeding.
- Allergy to study medication
- Simultaneous participation in another clinical trial with an experimental treatment
Key Trial Info
Start Date :
July 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 30 2021
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT04359290
Start Date
July 1 2020
End Date
July 30 2021
Last Update
August 24 2021
Active Locations (1)
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1
Andreas Neubauer
Marburg, Germany, D-35043