- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04338958
Ruxolitinib in Covid-19 Patients With Defined Hyperinflammation (RuxCoFlam)
A Phase-II Clinical Trial for First Line Treatment of Stage II/III Covid-19 Patients to Treat Hyperinflammation
Study Overview
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
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Gera, Germany, 07548
- Srh Wald-Klinikum Gera Gmbh
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Jena, Germany, 07747
- University Hospital Jena
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Lübeck, Germany, 23538
- UKSH, Campus Lübeck
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Stuttgart, Germany, 70174
- Klinikum der Landeshauptstadt Stuttgart gKöR
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Ulm, Germany, 89081
- Universitatsklinikum Ulm
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Villingen-Schwenningen, Germany, 78052
- Schwarzwald-Baar Klinikum Villingen-Schwenningen GmbH
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / 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
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
overall response rate in reversal of hyperinflammation
Time Frame: day 7 after start of therapy
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Patients achieving 25% reduction in hyperinflammation score (CIS) compared to baseline at day 7
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day 7 after start of therapy
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Andreas Hochhaus, Prof. Dr., University Hospital Jena
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RuxCoFlam
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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