SARS-CoV-2 induced ARDS
Conditions
Interventions
Trade Name: JAKAVI
Product Name: Ruxolitinib
Pharmaceutical Form: Tablet
INN or Proposed INN: Ruxolitinib
CAS Number: 1092939-17-7
Current Sponsor code: KKS-278
Other descriptive name: RUXOLITINIB PHO
Sponsors
Philipps-Universität Marburg
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Overall survival - Assessment of the duration of ventilation support - Assessment of the extent of cytokine storm reduction (IL-6, CRP, ferritin) - To assess time on ICU - To assess toxicity and safety of ruxolitinib treatment - To assess seroconversion under ruxolitinib (SARS-Co-19- IgG) - If possible to assess pulmonary function ;Timepoint(s) of evaluation of this end point: 90 days after registration | — |
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Overall survival after 28 days after registration into this trial;Secondary Objective: - Overall survival after 90 days after registration into this trial - Assessment of the duration of ventilation support - Assessment of the extent of cytokine storm reduction (IL-6, CRP, ferritin) - To assess time on ICU - To assess toxicity and safety of ruxolitinib treatment - To assess seroconversion under ruxolitinib (SARS-Co-19- IgG) - If possible to assess pulmonary function (time point discharge from hospital) ;Primary end point(s): Overall survival ;Timepoint(s) of evaluation of this end point: 28 days after registration | — |
Countries
Germany
Contacts
Public ContactKKS Marburg
Koordinierungszentrum für Klinische Studien (KKS)
Outcome results
None listed