JPRN-jRCTs052200134已完成1 期
A clinical study to evaluate efficacy and safety of a new virus adsorption therapy in patients with severe COVID-19 infection - CATCH-COVID
Isaka Yoshitaka0 个研究点目标入组 7 人开始时间: 2021年2月15日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 7
研究概览
简要总结
The results of this study showed that blood viruses became negative during the observation period in all cases, and that 4 out of 7 patients were weaned from the ventilator. In this exploratory study, we compared the results with historical cohort data and found a trend toward earlier negative blood virus counts in cases treated with viral adsorption therapy. In addition, no serious or severe adverse events were observed in this study, therefore, no particular concern regarding safety were observed.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 18age old 至 ot applicable（—）
- 性别
- All
入选标准
- •1) Patients who show positive for nucleic acid of SARS-CoV-2 in the blood at the pre-enrollment test
- •2) Patients who need on artificial ventilator or ECMO
- •3) Patients who voluntarily give a written consent after receiving a thorough explanation and having an adequate understanding to be enrolled in the study
- •4) Patients whose age is 18 or elder when obtaining the consent . If the patient is under 20, the consent shuld be obtained from a legal representative such as a person in parental authority in addition to the patient itself.
排除标准
- •1) Patients whose circulatory dynamics is unstable and difficult to put on the adsorption therapy
- •2) Patients who are participating other interventional clinical studies
- •3) Patients who are pregnant or possibly pregnant or lactating
- •4) Patients judged by the principal investigator or subinvestigator inappropriate to be enrolled in the study
研究者
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