Ruxolitinib in Covid-19 Patients With Defined Hyperinflammation

• Status: Completed
• Trial end date: 2021-07-15
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Prof. Dr. med. Andreas Hochhaus; University of Jena

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.