Ruxolitinib for Treatment of Covid-19 Induced Lung Injury ARDS
Ključne riječi
Sažetak
Opis
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.
Datumi
| Posljednja provjera: | 03/31/2020 |
| Prvo podneseno: | 04/14/2020 |
| Predviđena prijava poslana: | 04/19/2020 |
| Prvo objavljeno: | 04/23/2020 |
| Posljednje ažuriranje poslano: | 07/05/2020 |
| Posljednje ažuriranje objavljeno: | 07/07/2020 |
| Stvarni datum početka studija: | 06/30/2020 |
| Procijenjeni datum primarnog završetka: | 11/30/2020 |
| Procijenjeni datum završetka studije: | 06/30/2021 |
Stanje ili bolest
Intervencija / liječenje
Drug: Ruxolitinib treatment
Faza
Grupe ruku
| Ruka | Intervencija / liječenje |
|---|---|
| Experimental: Ruxolitinib treatment Ruxolitinib will be administered p.o. or by gavage feeding for max 28 days | Drug: Ruxolitinib treatment Ruxolitinib will be administered p.o. or by gavage feeding starting with 2 x 10mg bid dose at day 1 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; |
Kriterij prihvatljivosti
| Dobni uvjeti za studiranje | 18 Years Do 18 Years |
| Spolovi koji ispunjavaju uvjete za studij | All |
| Prihvaća zdrave volontere | Da |
| Kriteriji | Inclusion Criteria: 1. Male or non-pregnant female adult ≥18 years of age at time of enrollment. 2. 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. 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 4. Written informed consent if possible Exclusion Criteria: 1. Uncontrolled HIV infection 2. Active tuberculosis 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 |
Ishod
Primarne mjere ishoda
1. Overall survival [28 days after registration into trial]
Sekundarne mjere ishoda
1. Assessment of the duration of ventilation support [registration until 90 days after registration into trial]
2. cytokine storm [registration until 90 days after registration into trial]
3. time on ICU [registration until 90 days after registration into trial]
4. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [registration until 90 days after registration into trial]
5. time frame for seroconversion under ruxolitinib treatment (SARS-Co-19- IgG) [registration until 90 days after registration into trial]
6. pulmonary function assessed by a CT scan [registration until 90 days after registration into trial]
7. overall survival [90 days after registration into trial]
