Ruxolitinib for treatment of Covid-19 Patienten with acute respiratorydistress syndrome

Phase 1

Active, not recruiting

• Conditions: SARS-CoV-2 induced ARDS; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2020-001732-10-DE
• Lead Sponsor: Philipps-Universität Marburg

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-04-27
• Last Update Posted: 2 August 2021

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified