NCT04569877

GM-CSF Inhalation to Prevent ARDS in COVID-19 Pneumonia

Granulocyte Macrophage Colony Stimulating Factor (GM-CSF) Inhalation to Prevent ARDS in COVID-19 Pneumonia (GI-COVID)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 63 (actual)
• Sponsor: University of Giessen · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To assess the safety and tolerability of inhaled molgramostim nebuliser solution in patients with COVID-19 pneumonia.

Detailed description

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.

Conditions

• Severe Acute Respiratory Syndrome (SARS) Pneumonia
• COVID-19 Pneumonia

Interventions

Type	Name	Description
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

Timeline

• Start date: 2020-09-24
• Primary completion: 2022-06-21
• Completion: 2022-09-20
• First posted: 2020-09-30
• Last updated: 2023-05-10

Locations

9 sites across 1 country: Germany