Ruxolitinib in Covid-19 Patients With Defined Hyperinflammation (RuxCoFlam)
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|ClinicalTrials.gov Identifier: NCT04338958|
Recruitment Status : Completed
First Posted : April 8, 2020
Last Update Posted : August 13, 2021
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|Condition or disease||Intervention/treatment||Phase|
|Covid-19||Drug: Ruxolitinib||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||193 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||single arm, non-randomized|
|Masking:||None (Open Label)|
|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|
|Actual Primary Completion Date :||July 15, 2021|
|Actual Study Completion Date :||July 15, 2021|
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
- 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
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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
- 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.
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
|SRH Wald-Klinikum Gera GmbH|
|Gera, Germany, 07548|
|University Hospital Jena|
|Jena, Germany, 07747|
|UKSH, Campus Lübeck|
|Lübeck, Germany, 23538|
|Klinikum der Landeshauptstadt Stuttgart gKöR|
|Stuttgart, Germany, 70174|
|Ulm, Germany, 89081|
|Schwarzwald-Baar Klinikum Villingen-Schwenningen GmbH|
|Villingen-Schwenningen, Germany, 78052|
|Principal Investigator:||Andreas Hochhaus, Prof. Dr.||University Hospital Jena|
|Responsible Party:||Prof. Dr. med. Andreas Hochhaus, Principal Investigator, University of Jena|
|Other Study ID Numbers:||
|First Posted:||April 8, 2020 Key Record Dates|
|Last Update Posted:||August 13, 2021|
|Last Verified:||August 2021|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Respiratory Tract Infections
RNA Virus Infections
Respiratory Tract Diseases