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Ruxolitinib in Covid-19 Patients With Defined Hyperinflammation (RuxCoFlam)

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: NCT04338958
Recruitment Status : Recruiting
First Posted : April 8, 2020
Last Update Posted : May 1, 2020
Sponsor:
Information provided by (Responsible Party):
Prof. Dr. med. Andreas Hochhaus, University of Jena

Brief Summary:
RuxCoFlam is a single arm, non-randomized open phase II trial for front line treatment of Covid-19 patients with defined hyperinflammation.

Condition or disease Intervention/treatment Phase
Covid-19 Drug: Ruxolitinib Phase 2

Detailed Description:
RuxCoFlam is a single arm, non-randomized open phase II trial for front line treatment of Covid-19 patients with defined hyperinflammation. Purpose of the study is the reversal of hyperinflammation to improve pulmonary function, reduce respiratory dependency and reduce mortality. Patients with a hyperinflammation Score 10/16 without a clinical diagnosis of sepsis will be treated with 2 x 10mg Ruxolitinib with defined response adapted dose escalation up to 2 x 20mg for a duration of 7 days with clinical and/or radiographic response assessment. Inflammation assessment will be performed every other day (day 3, 5,7) using the CIS. In patients with unaffected CIS alteration < 25% or increasing CIS > 25% dose escalation by 5mg steps (15mg, day3; 20mg day 5) at the investigator´s discretion. Treatment can be extended up to 28 days if clinically indicated and the benefits of treatment outweigh the risks. Primary endpoint of the study is the overall response rate in reversal of hyperinflammation at day 7 compared to baseline. Secondary endpoints are total use of assisted oxygenation dependency (duration (days) of invasive/non-invasive ventilation or duration (days) of high-flow Oxygen support), radiologic response (reversal of pulmonary Covid-signs, Lung-XRay/CT), day 15 clinical status and day 15 and day 29 mortality. Patients aged ≥18 years hospitalized with COVID-19 pneumonia (demonstrated by CXRAY or chest CT), with a study specific Covid Inflammation Score ≥ 10 are eligible. Patients with active tuberculosis or uncontrolled bacterial, fungal, viral, or other infection (besides SARS-CoV-2 virus) will be excluded from the study.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: single arm, non-randomized
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase-II Clinical Trial for First Line Treatment of Stage II/III Covid-19 Patients to Treat Hyperinflammation
Actual Study Start Date : April 22, 2020
Estimated Primary Completion Date : January 31, 2021
Estimated Study Completion Date : August 31, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Ruxolitinib
2 x 10mg Ruxolitinib with defined response adapted dose escalation up to 2 x 20mg for a duration of 7 days
Drug: Ruxolitinib
2 x 10mg Ruxolitinib with defined response adapted dose escalation up to 2 x 20mg for a duration of 7 days with clinical and/or radiographic response assessment




Primary Outcome Measures :
  1. overall response rate in reversal of hyperinflammation [ Time Frame: day 7 after start of therapy ]
    Patients achieving 25% reduction in hyperinflammation score (CIS) compared to baseline at day 7



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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. Patient or guardian must provide written informed consent (and assent if applicable) before any study assessment is performed.
  • 2. Male and female patients aged ≥ 18 years.
  • 3. Patients with temperature > 37.3°C
  • 4. Patients with respiratory symptoms and/or hypoxia SpO2 < 93%
  • 5. Patients with Covid-19 stage II and stage III
  • 6. Patients with lung imaging showing bi-pulmonary infiltrates (chest X-ray or CT scan).
  • 7. Patients, with a Covid Inflammation Score ≥ 10

Exclusion Criteria:

  • 1. History of hypersensitivity to any drugs or metabolites of similar chemical classes as ruxolitinib.
  • 2. Uncontrolled active bacterial, fungal, viral, or other infection (besides COVID-19).
  • 3. Active Tuberculosis infection.
  • 4. Known Positivity for HBV, HCV or HIV.
  • 5. Patients who are on long-term use of oral anti-rejection or immunomodulatory drugs
  • 6. Participating in any other interventional clinical trial for COVID-19.
  • 7. Treatment with cytokine-directed agents such as anti-IL6 or anti-IL1R directed antibodies (i.e. tocilizumab, anakinra). Other treatment modalities used in locally adapted SOPs (corticosteroids, chloroquine, hydroxychloroquine, lopinavir-ritonavir) may be given with daily documentation of dose and schedule.
  • 8. ALT or AST > 5 x ULN detected within 24 hours at screening (according to local laboratory reference ranges).
  • 9. ANC < 500/µL at screening (according to local laboratory reference ranges).
  • 10. Platelet count < 50,000/µL at screening (according to local laboratory reference ranges).
  • 11. Hemoglobin < 6 g/dl (3.73mmol/l)
  • 12. Pregnant or nursing (lactating) women.
  • 13. Female patients of childbearing potential (e.g. are menstruating) and male patients who do not agree to abstinence or, if sexually active, do not agree to the use of highly effective contraception as defined below, throughout the study and for up to 90 days after stopping treatment, OR Female patients of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception as defined below, throughout the study and for up to 90 days after stopping treatment.

Highly effective contraception methods include:

  • Total abstinence (when this is in line with the preferred and usual lifestyle of the patient). Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception.
  • Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy), total hysterectomy or tubal ligation at least six weeks before taking study treatment. In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment.
  • Male sterilization (at least 6 months prior to screening). The vasectomized male partner should be the sole partner for that patient.
  • Use of oral, injected or implanted hormonal methods of contraception. Placement of an intrauterine device (IUD) or intrauterine system (IUS) or other forms of hormonal contraception that have comparable efficacy (failure rate <1%), for example hormone vaginal ring or transdermal hormone contraception (in case of oral contraception, patients should have been using the same pill on a stable dose for a minimum of 3 months before Screening).

Women are considered post-menopausal and not of child bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy), total hysterectomy or tubal ligation at least six weeks ago. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment is she considered not of child bearing potential.


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): NCT04338958


Contacts
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Contact: Andreas Hochhaus, Prof. Dr. +49 3641 ext 9324201 ruxcoflam@med.uni-jena.de
Contact: Christian Fabisch, Dr. +49 3641 ext 9396670 ruxcoflam@med.uni-jena.de

Locations
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Germany
Universitätsmedizin Göttingen - Klinik für Hämatologie und Onkologie Not yet recruiting
Göttingen, Germany, 37075
Contact: Justin Hasenkamp, Dr. med.         
University Hospital Jena Recruiting
Jena, Germany, 07747
Contact: Andreas Hochhaus, Prof. Dr.    +49 3641 ext 9324201    ruxcoflam@med.uni-jena.de   
Principal Investigator: Andreas Hochhaus, Prof. Dr.         
Klinikum der Landeshauptstadt Stuttgart gKöR Not yet recruiting
Stuttgart, Germany, 70174
Contact: Gerald Illerhaus, Prof. Dr.         
Universitätsklinikum Ulm Not yet recruiting
Ulm, Germany, 89081
Contact: Konstanze Döhner, Prof. Dr.         
Schwarzwald-Baar Klinikum Villingen-Schwenningen GmbH Not yet recruiting
Villingen-Schwenningen, Germany, 78052
Contact: Paul La Rosée, Prof. Dr.         
Universitätsklinikum Würzburg Not yet recruiting
Würzburg, Germany, 97080
Contact: Anna Frey, PD Dr. med.         
Sponsors and Collaborators
University of Jena
Investigators
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Principal Investigator: Andreas Hochhaus, Prof. Dr. University Hospital Jena
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Prof. Dr. med. Andreas Hochhaus, Principal Investigator, University of Jena
ClinicalTrials.gov Identifier: NCT04338958    
Other Study ID Numbers: RuxCoFlam
First Posted: April 8, 2020    Key Record Dates
Last Update Posted: May 1, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No