Overview

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

Status:
Recruiting

Trial end date:
2022-12-25

Target enrollment:
0

Participant gender:
All

Summary

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

Phase:

Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

University of Giessen

Treatments:

Molgramostim
Pharmaceutical Solutions
Sargramostim

Criteria

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