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

Justus-Liebig-University Gießen0 个研究点目标入组 238 人开始时间: 2020年5月5日最近更新: 2020年12月7日

试验速览

暂无简介。

•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

•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

发起方

Justus-Liebig-University Gießen