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临床试验/NCT04387786
NCT04387786已完成不适用

Nebulized In-line Endotracheal Dornase Alfa and Albuterol Administered to Mechanically Ventilated COVID-19 Patients: A Case Series

Feinstein Institute for Medical Research1 个研究点 分布在 1 个国家目标入组 5 人开始时间: 2020年3月31日最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
5
试验地点
1
主要终点
Number of participants who survived COVID-19

研究概览

简要总结

Mechanically ventilated patients with coronavirus disease 2019 (COVID-19) have a mortality of 24-53%, in part due to distal mucopurulent secretions interfering with ventilation. Dornase alfa is recombinant human DNase 1 and digests DNA in mucoid sputum. Nebulized dornase alfa is FDA-approved for cystic fibrosis treatment. DNA from neutrophil extracellular traps (NETs) contributes to the viscosity of mucopurulent secretions. NETs are found in the serum of patients with severe COVID-19, and targeting NETs reduces mortality in animal models of acute respiratory distress syndrome (ARDS). Thus, dornase alfa may be beneficial to patients with severe COVID-19-acting as a mucolytic and targeting NETs.

详细描述

Demographic, clinical data, and outcomes were collected from the electronic medical records of five mechanically ventilated patients with COVID-19-including three requiring veno-venous extracorporeal membrane oxygenation (VV-ECMO)-treated with nebulized in-line endotracheal dornase alfa co-administered with albuterol (used to increase delivery to the alveoli), between March 31 and April 24, 2020. Data on tolerability and responses, including longitudinal values capturing respiratory function and inflammatory status, were analyzed.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • mechanically ventilated patients with COVID-19

排除标准

  • healthy, non-ventilated

结局指标

主要结局

Number of participants who survived COVID-19

时间窗: 2-4 months

survival will be determined from the enterprise health record reporting database

Number of participants discharged from the intensive care unit (ICU)

时间窗: 2 months

discharge from ICU will be determined from the enterprise health record reporting database

次要结局

  • Mean change in FiO2(2 months)

研究者

发起方
Feinstein Institute for Medical Research
申办方类型
Other
责任方
Principal Investigator
主要研究者

Betsy J Barnes

Investigator/Professor

Feinstein Institute for Medical Research

研究点 (1)

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