Granulocyte Macrophage Colony Stimulating Factor (GM-CSF) Inhalation to prevent ARDS in COVID-19 pneumonia

Phase 1

• Conditions: COVID-19 pneumonia; MedDRA version: 23.1Level: PTClassification code 10084380Term: COVID-19 pneumoniaSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2020-001654-21-DE
• Lead Sponsor: Justus-Liebig-University Gießen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-05-05
• Last Update Posted: 7 December 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 238

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 SpO2 = 94% >= 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 potential

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 119
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 119

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified