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A Phase-II Clinical Trial for First Line Treatment of Stage II/III Covid-19 Patients to Treat Hyperinflammation

Status: Planned (Transit Ethics), pub.

Purpose / Objectives

Primary Outcome

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


Secondary Outcomes

Efficacy of ruxolitinib + standard-of-care (SoC) (Time Frame: Days 15 and 29 after start of therapy )

  • Duration of hospitalization, reduction of mechanical ventilation, duration and amount of oxygen supplementation, reduction of side effects



Patient attributes



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.

[continued in the study protocol]


Trial design

  • Phase II
  • Multicenter
  • Prospective
  • One-arm
  • Open Label


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

Documents (password protected)

Responsibilities in overall trial

Friedrich-Schiller-Universität Jena

    National Coordinating Investigator

    Prof. Dr. Andreas Hochhaus