To assess the safety and tolerability of inhaled molgramostim nebuliser solution in patients with COVID-19 pneumonia.
COVID-19 pneumonia is induced by the newly emerging pandemic Severe acute respiratory
Syndrome (SARS) coronavirus 2 and results in progression to the acute respiratory distress
syndrome (ARDS). Apart from protective ventilation, fluid restriction, prone positioning and
extracorporeal membrane oxygenation (ECMO), no specific therapeutic options exist to treat
this devastating disease with a mortality rate of up to 50%. The growth factor
granulocyte-macrophage colony-stimulating factor (GM-CSF) is widely recognized to promote
differentiation and mobilization of different myeloid leukocyte subsets including
neutrophils, tissue macrophages/dendritic cells or their circulating precursors. GM-CSF was
found to be crucial for alveolar epithelial repair following hyperoxic and inflammatory lung
injury.The aim of the current trial is to prevent progression to ARDS in COVID-19 pneumonia
patients by preemptive GM-CSF Inhalation.
Drug: Molgramostim nebuliser solution
300μg molgramostim nebuliser solution nebulised seven times within 7 days via rapid nebuliser system
Other: Placebo nebuliser solution
Placebo nebulised seven times within 7 days via rapid nebuliser system
Inclusion Criteria:
1. Signed informed consent form by the patient according to local regulations
2. Man or non-pregnant woman
3. Age ≥18 years
4. Willingness of patients with reproductive potential to use highly effective
contraceptive methods by practicing abstinence or by using at least two methods of
birth control from the date of consent to the end of the study. If abstinence could
not be practiced, a combination of hormonal contraceptive (oral, injectable, or
implants) and a barrier method (condom, diaphragm with a vaginal spermicidal agent)
has to be used *.
5. Lab-confirmed COVID-19 pneumonia where pneumonia is diagnosed by radiographic
infiltrates by imaging (chest x-ray, CT scan, etc.), OR clinical assessment (evidence
of rales/crackles on exam) AND pulse oximeter oxygen saturation ≤ 94% at room air in
patients that do not have chronic hypoxia; or less than their baseline oxygenation in
patients that suffer from chronic hypoxia
6. Negative serum pregnancy test in women of childbearing potentia
Exclusion Criteria:
1. Pregnancy or breast feeding
2. Autoimmune thrombocytopenia, myelodysplastic syndromes with > 20% marrow blast cells
3. History or presence of hypersensitivity or idiosyncratic reaction to molgramostim
(e.g. Leucomax®) or to related compounds (e.g. Leukine®)
4. Patient not able to use nebulizer device as well as immediately foreseeable mechanical
ventilation of the patient
5. Simultaneous participation in another clinical trial with an experimental treatment
Universitätsklinikum Carl Gustav Carus Dresden
Dresden, Germany
Universitätsklinikum Essen
Essen, Germany
Krankenhaus Nordwest GmbH
Frankfurt am Main, Germany
Universitätsklinikum Frankfurt
Frankfurt am Main, Germany
Universitätsklinikum Giessen und Marburg GmbH, Standort Giessen
Gießen, Germany
Medizinische Hochschule Hannover
Hannover, Germany
Universitätsklinikum Heidelberg
Heidelberg, Germany
Lungenfachklinik Immenhausen
Immenhausen, Germany
Sana Klinikum Offenbach
Offenbach am Main, Germany
Susanne Herold, Prof. Dr., Principal Investigator
Universitätsklinikum Giessen und Marburg (UKGM)