GM-CSF Inhalation to Prevent ARDS in COVID-19 Pneumonia (GI-COVID)

University of Giessen

Status and phase: Completed; Phase 2

Conditions: COVID-19 Pneumonia; Severe Acute Respiratory Syndrome (SARS) Pneumonia

Treatments: Drug: Molgramostim nebuliser solution; Other: Placebo nebuliser solution

Study type: Interventional

Funder types: Other

Identifiers

NCT04569877

KKS-279

2020-001654-21 (EudraCT Number)

Details and patient eligibility

About

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

Full 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.

Enrollment: 63 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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63 participants in 2 patient groups, including a placebo group

Molgramostim nebuliser solution

Experimental group

Description:

300μg molgramostim nebuliser solution

Treatment:

Drug: Molgramostim nebuliser solution

Placebo nebuliser solution

Placebo Comparator group

Description:

Placebo nebuliser solution

Treatment:

Other: Placebo nebuliser solution