Granulocyte Macrophage Colony Stimulating Factor (GM-CSF) Inhalation to Prevent ARDS in COVID-19 Pneumonia (GI-COVID)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 63
- 试验地点
- 9
- 主要终点
- Mechanical ventilation
研究概览
简要总结
To assess the safety and tolerability of inhaled molgramostim nebuliser solution in patients with COVID-19 pneumonia.
详细描述
COVID-19 pneumonia is induced by the newly emerging pandemic Severe acute respiratory Syndrome (SARS) coronavirus 2 and results in progression to the acute respiratory distress syndrome (ARDS). Apart from protective ventilation, fluid restriction, prone positioning and extracorporeal membrane oxygenation (ECMO), no specific therapeutic options exist to treat this devastating disease with a mortality rate of up to 50%. The growth factor granulocyte-macrophage colony-stimulating factor (GM-CSF) is widely recognized to promote differentiation and mobilization of different myeloid leukocyte subsets including neutrophils, tissue macrophages/dendritic cells or their circulating precursors. GM-CSF was found to be crucial for alveolar epithelial repair following hyperoxic and inflammatory lung injury.The aim of the current trial is to prevent progression to ARDS in COVID-19 pneumonia patients by preemptive GM-CSF Inhalation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Molgramostim nebuliser solution
300μg molgramostim nebuliser solution
干预措施: Molgramostim nebuliser solution (Drug)
Placebo nebuliser solution
Placebo nebuliser solution
干预措施: Placebo nebuliser solution (Other)
结局指标
主要结局
Mechanical ventilation
时间窗: During 15 days
Need for mechanical ventilation within 15 days after randomization
次要结局
- Vaso-active drugs(At day 29)
- Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability](At day 0 (day before first dose), day 1-9, and day 15)
- Clinical parameter: blood pressure(Max. 48 hours before day 0, at day 0, day 1-7, day 8-9 and day 15)
- Clinical parameter: temperature(Max. 48 hours before day 0, at day 0, day 1-7, day 8-9 and day 15)
- Clinical parameter: respiratory rate(Max. 48 hours before day 0, at day 0, day 1-7, day 8-9 and day 15)
- Laboratory: ferritin(At day 0, day 1-7, day 8-9 and day 15)
- Mortality(At day 29)
- Oxygen supply(At day 0, day 1-7, day 8-9 (24 hours/48 hours post dose) and day 15)
- Severe acute respiratory syndrome coronavirus 2 polymerase chain reaction (PCR)(Max. 48 hours before day 0 and at day 8-9)
- Laboratory: C-reactive protein test(At day 0, day 1-7, day 8-9 and day 15)
- Bacterial pneumonia(At day 0, day 1-7, day 8-9 and day 15)
- Laboratory: procalcitonin(At day 0, day 1-7, day 8-9 and day 15)
- GM-CSF(At day 0 and day 1-7)
- Clinical status of subject at day 15 and day 29 (on a 7-point ordinal scale):(At day 15 and day 29)
- Clinical parameter: heart beat(Max. 48 hours before day 0, at day 0, day 1-7, day 8-9 and day 15)
- Laboratory: Interleukin-6(At day 0, day 1-7, day 8-9 and day 15)