Usefulness of DORNASE (Pulmozyme®) in Patients With COVID-19 Respiratory Insufficiency on High-Flow Oxygen Therapy
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Intubations
研究概览
简要总结
COVID-19 pneumonia manifests among others with a thick bronhial secretion. It contains an increased number of neutrophil extracellular traps (NETs), formed during netosis. DNA is a major component in NETs. DNAse alfa (Pulmozyme®, Roche) is a recombinant human enzyme, registered for inhalations in patients with Cystic fibrosis, in which NETs are also a typical characteristic. DNAse alfa inhalations are typically well tolerated and with no major side effects. Some initial reports exist of using DNAse alfa inhalations in COVID-19 patients, that had benefitial effects. There are some trials registered with ClinicalTrials, investigating the usufulness of DNAse alfa in intubated patients, but the investigators have no knowledge of a trial, investigating the usufulness of this drug in patients receiving High Flow Nasal Oxygen therapy.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Positive SARS-CoV-2 RNA PCR swab
- •inflamatory phase of infection
排除标准
- •pregnancy
- •previous treatment with DNAse alfa
研究组 & 干预措施
4% saline
4% Saline inhalations twice daily
干预措施: Saline (Drug)
Pulmosyme
DNAse alpha inhalations twice daily
干预措施: Dornase Alfa (Drug)
结局指标
主要结局
Intubations
时间窗: 7 days
Number of intubations necessary
次要结局
- PaO2/FiO2(7 days)
- inflamation(7 days)
研究者
Marko Zlicar
Head of department
University Medical Centre Ljubljana