Ignite Creation Date:
2024-05-06 @ 3:13 PM
Last Modification Date:
2024-10-26 @ 1:46 PM
Study NCT ID:
NCT04569877
Status:
COMPLETED
Last Update Posted:
2023-05-10
First Post:
2020-09-25
Brief Title:
GM-CSF Inhalation to Prevent ARDS in COVID-19 Pneumonia
Sponsor:
University of Giessen
Organization:
University of Giessen
Study Overview
Official Title:
Granulocyte Macrophage Colony Stimulating Factor GM-CSF Inhalation to Prevent ARDS in COVID-19 Pneumonia GI-COVID
Status:
COMPLETED
Status Verified Date:
2022-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
GI-COVID
Brief 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 macrophagesdendritic cells or their circulating precursors GM-CSF was found to be crucial for alveolar epithelial repair following hyperoxic and inflammatory lung injuryThe aim of the current trial is to prevent progression to ARDS in COVID-19 pneumonia patients by preemptive GM-CSF Inhalation
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2020-001654-21 | EUDRACT_NUMBER | None | None |