COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04569877

Susanne Herold

not reported

2020-09-30

Completed

RCT

Randomized

Parallel

Blind label

multi-center

Treatment

inclusion criteria: signed informed consent form by the patient according to local regulations man or non-pregnant woman age ≥18 years 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 *. 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 negative serum pregnancy test in women of childbearing potentia

pregnancy or breast feeding autoimmune thrombocytopenia, myelodysplastic syndromes with > 20% marrow blast cells history or presence of hypersensitivity or idiosyncratic reaction to molgramostim (e.g. leucomax®) or to related compounds (e.g. leukine®) patient not able to use nebulizer device as well as immediately foreseeable mechanical ventilation of the patient simultaneous participation in another clinical trial with an experimental treatment

2

University of Giessen

18

100

Germany

Severe disease at enrollment

6: Severe disease at enrollment

63

Mechanical ventilation

None

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"}]