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).

RUXOCOIL

AcronymISRCTNEudraCTNCT (clinicaltrials.gov)DRKS

A single-arm, open-label, phase II study of ruxolitinib in Covid-19 patients at risk of developing acute respiratory distress syndrome

Status: Planned (Transit Ethics), pub.

Purpose / Objectives

Primary Outcome

Overall survival after 28 days after registration into this trial

 

Secondary Outcomes

  • Overall survival after 90 days after registration into this trial
  • Assessment of the duration of ventilation support
  • Assessment of the extent of cytokine storm reduction (IL-6, CRP, ferritin)
  • To assess time on ICU
  • To assess toxicity and safety of ruxolitinib treatment
  • To assess seroconversion under ruxolitinib (SARS-Co-19- IgG)
  • To assess pulmonary function (time point discharge from hospital)

 

Diagnosis

Patient attributes

Inclusion criteria

In order to be eligible to participate in this study, a patient must meet all of the following criteria:

  1. Male or non-pregnant female adult ≥18 years of age at time of enrollment
  2. Has laboratory-confirmed SARS-CoV-2 infection as determined by PCR or other commercial or public health assay (result of the PCR is not necessary for inclusion, but has to be approved latest within 40 hours after enrollment)
  3. Severe lung disease as defined by following: 
    • Recent intubation
    • Requirement of invasive ventilation moderate to severe pulmonary oxygen exchange disturbance as defined by (PaO2/FiO2) ≤ 200 mmHg at a PEEP ≥ 5mm H2O
    • Serum LDH > 283 U/l
    • Ferritin above normal value
    • CT‐scan: pulmonary infiltration compatible with Covid‐19 disease
  4. Written informed consent if possible

 

Exclusion criteria

An individual who meets any of the following criteria will be excluded from participation in this study:

  1. Uncontrolled HIV infection
  2. Active tuberculosis
  3. Chronic kidney disease requiring dialysis
  4. ALT/AST > 5 times the upper limit of normal
  5. Pregnancy or breast feeding
  6. Allergy to study medication
  7. Simultaneous participation in another clinical trial with an experimental treatment

 

Trial design

  • Phase II
  • One-arm
  • Open Label

Intervention

Ruxolitinib will be administered p.o. or by gavage feeding starting with 2 x 10mg bid dose at day 1 and can be increased up to 2 x 15mg bid from day 2 to day 28 (max) (depending on platelet counts and renal function). Dosing will be adjusted according to toxicity and kidney function.

Documents (password protected)

Responsibilities in overall trial

Philipps-Universität Marburg

    National Coordinating Investigator

    Prof. Dr. med. Andreas Neubauer