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Ruxolitinib for Treatment of Covid-19 Induced Lung Injury ARDS (RuXoCoil)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04359290
Recruitment Status : Not yet recruiting
First Posted : April 24, 2020
Last Update Posted : April 27, 2020
Sponsor:
Information provided by (Responsible Party):
Philipps University Marburg Medical Center

Brief 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.

Condition or disease Intervention/treatment Phase
ARDS, Human COVID Drug: Ruxolitinib administration Phase 2

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: 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 adminstered in the morning and evening. Dosing will be adjusted according to toxicity and kidney function; open design, sinlge arm
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Ruxolitinib for Treatment of Covid-19 Induced Lung Injury ARDS A Single-arm, Open-label, Proof of Concept Study
Estimated Study Start Date : May 2020
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : November 2020


Arm Intervention/treatment
Experimental: Ruxolitinib treatment
Ruxolitinib will be administered p.o. or by gavage feeding for max 28 days
Drug: Ruxolitinib administration
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 adminstered in the morning and evening. Dosing will be adjusted according to toxicity and kidney function;




Primary Outcome Measures :
  1. Overall survival [ Time Frame: 28 days after registration into trial ]
    To determine the efficacy of ruxolitinib measured by overall survival


Secondary Outcome Measures :
  1. Assessment of the duration of ventilation support [ Time Frame: registration unitl 90 days after registration into trial ]
    Assessment of the duration of ventilation support

  2. cytokine storm [ Time Frame: registration unitl 90 days after registration into trial ]
    Assessment of the extent of cytokine storm reduction (IL-6, CRP, ferritin)

  3. time on ICU [ Time Frame: registration unitl 90 days after registration into trial ]
    To assess time on ICU

  4. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: registration unitl 90 days after registration into trial ]
    To assess toxicity and safety of ruxolitinib treatment

  5. time frame for seroconversion under ruxolitinib treatment (SARS-Co-19- IgG) [ Time Frame: registration unitl 90 days after registration into trial ]
    To assess the timeframe for seroconversion under ruxolitinib treatment (SARS-Co-19- IgG)

  6. pulmonary function assessed by a CT scan [ Time Frame: registration unitl 90 days after registration into trial ]
    To assess pulmonary function (time point discharge from hospital) by CT scan

  7. overall survival [ Time Frame: 90 days after registration into trial ]
    To determine the efficacy of ruxolitinib measured by overall survival



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04359290


Contacts
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Contact: Andreas Neubauer, Prof Dr. +49 6421 58 66273 neubauer@staff.uni-marburg.de
Contact: Andreas Burchert, Prof Dr. +49 6421 58 65611 Burchert@med.uni-marburg.de

Sponsors and Collaborators
Philipps University Marburg Medical Center
Investigators
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Principal Investigator: Andreas Neubauer, Prof Dr. Universitätsklinikum Giessen und Marburg (UKGM)
Publications:
[WHO] World Health Organization. Clinical management of severe acute respiratory infection when novel coronavirus (nCoV) infection is suspected [Resource on the internet]. 2020 [updated 13 March 2020; cited 24 March 2020]. Available from: https://www.who.int/publications-detail/clinical-management-of-severe-acute-respiratory-infection-when-novel-coronavirus-(ncov)-infection-is-suspected
An Insight of comparison between COVID-19 (2019-nCoV disease) and SARS in pathology and pathogenesis. Author: Xiaolong Cai; Internet posting, of 27-Feb-2020 retrieved 24-Mar-2020. Cite as DOI: 10.31219/osf.io/hw34x
Ruxolitinib Prevents Cytokine Release Syndrome after CART Cell Therapy without Impairing the Anti-Tumor Effect in a Xenograft Model Saad S Kenderian, MD , Blood (2016) 128 (22): 652
The definition and risks of Cytokine Release Syndrome-Like in 11 COVID-19-Infected Pneumonia critically ill patients: Disease Characteristics and Retrospective Analysis Wenjun Wang Jr. et al Internet posting of 27-Feb-2020 retrieved 24-Mar-2020 Cite as: https://doi.org/10.1101/2020.02.26.20026989

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Responsible Party: Philipps University Marburg Medical Center
ClinicalTrials.gov Identifier: NCT04359290    
Other Study ID Numbers: KKS-278
First Posted: April 24, 2020    Key Record Dates
Last Update Posted: April 27, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Study protocoll will be provided after publicaton
Supporting Materials: Study Protocol
Time Frame: 3 Months after publication
Access Criteria: Central server

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Philipps University Marburg Medical Center:
Covid-19
ARDS
Ruxolitinib
Janus kinase
JAK1
JAK2
Additional relevant MeSH terms:
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Lung Injury
Respiratory Distress Syndrome, Adult
Lung Diseases
Respiratory Tract Diseases
Thoracic Injuries
Wounds and Injuries
Respiration Disorders