Ruxolitinib for Treatment of Covid-19 Induced Lung Injury ARDS

• Status: Completed
• Trial end date: 2021-07-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Philipps University Marburg Medical Center

Criteria

Inclusion 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:

1. Recent intubation

2. Requirement of invasive ventilation moderate to severe pulmonary oxygen exchange disturbance as defined by (PaO2/FiO2) ≤ 200 mmHg at a PEEP ≥ 5mm H2O

3. Serum LDH > 283 U/l

4. Ferritin above normal value

5. 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.

Exclusion Criteria:

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