COVID-19 trials registries data warehouse

https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-001654-21/DE

Koordinierungszentrum für Klinische Studien der Philipps-Universität Marburg (KKS Marburg) - Project manager

nelli.ens@kks.uni-marburg.de

2020-05-05

Completed

RCT

Randomized

Parallel

Blind label

multi-center

Treatment

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

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

2

Justus-Liebig-University Gießen

18

100

Germany

Moderate/severe disease at enrollment

4: Moderate/severe disease at enrollment

238

• Need for mechanical ventilation within 15 days after randomization

Declared number of arm (3.0) differs from found arms (2.0)

Phase 2

[{"arm_notes": "", "treatment_id": 812, "treatment_name": "Molgramostim", "treatment_type": "Csf", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]