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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
63
300μg molgramostim nebuliser solution nebulised seven times within 7 days via rapid nebuliser system
Placebo nebulised seven times within 7 days via rapid nebuliser system
Universitätsklinikum Carl Gustav Carus Dresden
Dresden, Germany
Universitätsklinikum Essen
Essen, Germany
Krankenhaus Nordwest GmbH
Frankfurt am Main, Germany
Universitätsklinikum Frankfurt
Frankfurt am Main, Germany
Mechanical ventilation
Need for mechanical ventilation within 15 days after randomization
Time frame: During 15 days
Clinical status of subject at day 15 and day 29 (on a 7-point ordinal scale):
1. Not hospitalized, no limitations on activities 2. Not hospitalized, limitation on activities; 3. Hospitalized, not requiring supplemental oxygen; 4. Hospitalized, requiring supplemental oxygen; 5. Hospitalized, on non-invasive ventilation or high flow oxygen devices; 6. Hospitalized, on invasive mechanical ventilation or ECMO; 7. Death.
Time frame: At day 15 and day 29
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Incidence of Treatment-Emergent Adverse Events \[Safety and Tolerability\] will be measured at day 0 (day before first dose), day 1-9, and day 15
Time frame: At day 0 (day before first dose), day 1-9, and day 15
Oxygen supply
Need for oxygen supply (l/min) to reach peripheral oxygen saturation of 98%
Time frame: At day 0, day 1-7, day 8-9 (24 hours/48 hours post dose) and day 15
Clinical parameter: temperature
Clinical parameter (4 times daily): temperature (°C degree)
Time frame: Max. 48 hours before day 0, at day 0, day 1-7, day 8-9 and day 15
Clinical parameter: blood pressure
Clinical parameter (4 times daily): blood pressure (mmHg)
Time frame: Max. 48 hours before day 0, at day 0, day 1-7, day 8-9 and day 15
Clinical parameter: heart beat
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Universitätsklinikum Giessen und Marburg GmbH, Standort Giessen
Giessen, Germany
Medizinische Hochschule Hannover
Hanover, Germany
Universitätsklinikum Heidelberg
Heidelberg, Germany
Lungenfachklinik Immenhausen
Immenhausen, Germany
Sana Klinikum Offenbach
Offenbach, Germany
Clinical parameter (4 times daily): hear beat (beats per minute)
Time frame: Max. 48 hours before day 0, at day 0, day 1-7, day 8-9 and day 15
Clinical parameter: respiratory rate
Clinical parameter (4 times daily): respiratory rate (breaths per minute)
Time frame: Max. 48 hours before day 0, at day 0, day 1-7, day 8-9 and day 15
Severe acute respiratory syndrome coronavirus 2 polymerase chain reaction (PCR)
Presence of Severe acute respiratory syndrome coronavirus 2 nucleic acid by PCR test in swabs or tracheal aspirates/bronchoalveolar lavage
Time frame: Max. 48 hours before day 0 and at day 8-9
Laboratory: C-reactive protein test
C-reactive protein test measures the amount of C-reactive protein in blood (mg/L)
Time frame: At day 0, day 1-7, day 8-9 and day 15
Laboratory: ferritin
Ferritin test measures the amount of ferritin in the blood (ng/ml)
Time frame: At day 0, day 1-7, day 8-9 and day 15
Laboratory: Interleukin-6
Interleukin-6 test (IL-6) measures the amount of IL-6 in the blood (pg/ml)
Time frame: At day 0, day 1-7, day 8-9 and day 15
Laboratory: procalcitonin
Procalcitonin (PCT) test measures the amount of PCT in the blood in (μg/l)
Time frame: At day 0, day 1-7, day 8-9 and day 15
Bacterial pneumonia
Occurrence of secondary bacterial pneumonia
Time frame: At day 0, day 1-7, day 8-9 and day 15
Vaso-active drugs
Days on vaso-active drugs in a 29-day period
Time frame: At day 29
Mortality
All-cause mortality
Time frame: At day 29
GM-CSF
GM-CSF levels in serum
Time frame: At day 0 and day 1-7