The purpose of this study is to evaluate the efficacy and safety of ruxolitinib in the treatment of patients with COVID-19 severe pneumonia.
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 a well established,
potent and selective inhibitor of Janus kinase (JAK)1 and JAK2, with modest to marked
selectivity against tyrosine kinase (TYK)2 and JAK3, respectively. Ruxolitinib interferes
with the signaling of a number of cytokines and growth factors that are important for
hematopoiesis and immune function.
Ruxolitinib (JAKAVI®) is currently approved in the European Union (EU) for the treatment of
disease-related splenomegaly or symptoms in adult patients with primary myelofibrosis (PMF)
(also known as chronic idiopathic MF), post-polycythemia vera myelofibrosis (PPV-MF) or
post-essential thrombocythemia myelofibrosis (PET-MF) and for the treatment of adult patients
with PV who are resistant to or intolerant of hydroxyurea (HU). In the US, ruxolitinib has
been approved in the treatment of steroid refractory graft versus host disease post
allogeneic stem cell transplantation.
Because many patients with severe respiratory disease due to COVID-19 have features
consistent with the cytokine release syndrome (CRS) and increased activation of the JAK/STAT
pathway, it is postulated that ruxolitinib might have a useful role in treating these
patients.
Drug: Ruxolitinib administration
Ruxolitinib will be administered p.o. or by gavage feeding starting with 2 x 10mg or 2 x 15mg bid dose at day 1 according to the investigator's decision and can be increased up to 2 x 15mg bid from day 2 to day 28 (max) (depending on platelet counts and renal function). Ruxolitinib will be administered in the morning and evening. Dosing will be adjusted according to toxicity and kidney function.If the patient is discharged before day 28, the therapy will be discontinued for discharge.
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
Andreas Neubauer
Marburg, Germany
Andreas Neubauer, Prof Dr., Principal Investigator
Universitätsklinikum Giessen und Marburg (UKGM)