As an infrastructure at the German Center for Infection Research (DZIF), the Clinical Trial Unit tracks DZIF's study activities in the “Healex Site Management System (SMS)”. Studies are sorted by indication and are continuously updated.

The study register has recently been expanded to include the category “COVID-19”. For the first time, not only DZIF study activities are presented here: In order to provide a comprehensive overview in the current pandemic situation of planned and already active COVID-19 studies in Germany, the Clinical Trial Unit is cooperating with researchers from various German Centers for Health Research and other networks.

For researchers: If your study is not yet included in our portal, please contact the project management of the Clinical Trial Unit (angela.steinbach@uk-koeln.de or vassiliki.dimitriou@uk-koeln.de).

RuxoCoFlaM

AcronymISRCTNEudraCTNCT (clinicaltrials.gov)DRKS
CINC424A0DE01T2020-001481-11NCT04338958

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

 

Diagnosis

Patient attributes

Age

18-99

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

Intervention

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