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COMPLETEDPhase 2NCT04569877

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

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

Lead sponsor: University of Giessen•9 locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

University of Giessen

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.

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

No

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

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: May 10, 2023Terms

Trial snapshot

StatusCOMPLETED

PhasePHASE2

Enrollment63

Start dateSep 2020

Last updatedMay 10, 2023

Condition

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

Locations shown

Universitätsklinikum Carl Gustav Carus Dresden

Dresden

Universitätsklinikum Essen

Essen

Krankenhaus Nordwest GmbH

Frankfurt am Main

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 10, 2023Data synced to Clareo: May 25, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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