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).

GI-HOPE

AcronymISRCTNEudraCTNCT (clinicaltrials.gov)DRKS
MOL-ARDS-0022014-002479-28NCT02595060

GM-CSF Inhalation to improve HOst defense and Pulmonary barrier rEstoration

Status: Active

Purpose / Objectives

Primary Outcome

To assess the efficacy of two different doses of inhaled molgramostim (150µg and 450µg) compared to placebo when administered to patients with pneumonia-associated ARDS, as measured by HOst defense and Pulmonary barrier rEstoration (GI-HOPE) Score.

 

Secondary Outcomes

  • To assess safety and tolerability of two different doses of inhaled molgramostim (150µg and 450µg) when administered to patients with pneumonia-associated ARDS.
  • To assess levels of GM-CSF (in serum) after 150µg and 450µg of inhaled molgramostim compared to placebo when administered to patients with pneumonia-associated ARDS.
  • To assess pulmonary barrier function, systemic inflammation and improvement in morbidity in patients with pneumonia-associated ARDS treated with inhaled molgramostim.

 

Diagnosis

Pneumonia associated Acute Respiratory Distress Syndrome (ARDS)

Patients with pneumonia-associated lung injury on pulmonary inflammation and barrier restoration.

Diseases [C] - Respiratory Tract Diseases [C08]

Patient attributes

Stage

Acute Respiratory Distress Syndrome (ARDS)

Age

18-75

Inclusion criteria

  1. Signed informed consent form by the patient or a legal representative according to local regulations
  2. Man or woman 18 to 75 years of age, inclusive
  3. Women who have been post-menopausal for more than 1 year or women of childbearing potential period using a highly efficient method of contraception (i.e. a method with less than 1% failure rate such as combined hormonal contraception, progesterone-only hormonal contraception, intrauterine device, intrauterine hormone-releasing system, bilateral tube occlusion, vasectomized partner, sexual abstinence) during dosing and hospitalisation. Women must have a negative serum or urine pregnancy test before the first dose of study medication and must not be lactating.
  4. Diagnosis of CAP-associated ARDS
  5. Requirement for positive pressure ventilation (non-invasive or via endotracheal tube) for more than 72 hours with inspiratory oxygen concentration (FiO2) ≥ 50% not longer than 14 days

 

Exclusion criteria

  1. Receiving vasopressors of >100 μg/min
  2. History of liver cirrhosis Child Pugh C, chronic hemodialysis (before severe CAP [sCAP]), lung cancer
  3. Malignancy with expected survival time of less than 6 months
  4. History of or listing for lung transplantation
  5. Immunosuppressive therapy within 3 weeks prior to screening (except low-dose ≤15 mg/day corticosteroid monotherapy)
  6. Any anti-malignant chemotherapy within 24 hours prior to first dose of study drug
  7. Acquired Immune Deficiency Syndrome (AIDS) or known history of Human Immunodeficiency Virus (HIV) infection
  8. Pregnancy
  9. Autoimmune thrombocytopenia, myelodysplastic syndromes with > 20% marrow blast cells
  10. History or presence of hypersensitivity or idiosyncratic reaction to molgramostim (e.g. Growgen®, Leucomax® Topleucon™) or to related compounds (e.g. Leukine®)
  11. Participation in another clinical trial within 90 days prior to the first dose of study drug

 

Trial design

  • Phase II
  • Multicenter
  • Randomized
  • Parallel
  • Double-blind

Intervention

GM-CSF is a myeloid cell growth and differentiation factor which is expected to activate local

lung mononuclear phagocytes (i.e., alveolar macrophages and pulmonary dendritic cells) for

improved host defense capacity. Furthermore, GM-CSF is expected to accelerate alveolar

epithelial cell regeneration and reconstitution of alveolar barrier function. These effects are

expected to result in improved gas exchange function and reduced morbidity. Molgramostim

is a water soluble non-glycosylated recombinant human (rh)GM-CSF produced in a strain of

Escherichia coli bearing a genetically engineered plasmid which contains a human GM-CSF

gene. It belongs to the drug class of antineoplastic and immunomodulating agents. The most

common use of molgramostim is as a medication to stimulate the production of white blood

cells and thus prevent neutropenia following chemotherapy. Recombinant human GM-CSF

products include Leucomax®, Leukocitim®, Growgen®, and Topleucon(molgramostim) and

Leukine® (sargramostim) (subcutaneous [SC] and intravenous [IV] formulations for oncological

use).

 

Documents (password protected)

Responsibilities in overall trial

Justus-Liebig-Universität Gießen

  • Tel. +49 (0) 6032/996-0
  • Fax +49 (0) 6032/996-2399

National Coordinating Investigator

Prof. Dr. Susanne Herold