Status:
COMPLETED
Ruxolitinib in Covid-19 Patients With Defined Hyperinflammation
Lead Sponsor:
University of Jena
Conditions:
Covid-19
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
RuxCoFlam is a single arm, non-randomized open phase II trial for front line treatment of Covid-19 patients with defined hyperinflammation.
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 22 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 15 2021
Estimated Enrollment :
193 Patients enrolled
Trial Details
Trial ID
NCT04338958
Start Date
April 22 2020
End Date
July 15 2021
Last Update
August 13 2021
Active Locations (6)
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1
SRH Wald-Klinikum Gera GmbH
Gera, Germany, 07548
2
University Hospital Jena
Jena, Germany, 07747
3
UKSH, Campus Lübeck
Lübeck, Germany, 23538
4
Klinikum der Landeshauptstadt Stuttgart gKöR
Stuttgart, Germany, 70174