Monitoring of COVID-19 Using Urine POC Kit
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 964
- 试验地点
- 7
- 主要终点
- Risk Stratification of COVID-19 Participants Using Urine Biomarkers
研究概览
简要总结
Coronavirus disease 2019 (COVID-19) is caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and in infected patients, it produces symptoms which range from completely asymptomatic to those expressing severe illness. Early recognition of those developing severe manifestations allows for rapid and appropriate intervention, including admission to intensive care unit and intensive care therapy, such as mechanical ventilation. A current problem is that only limited data exist predicting the clinical course of COVID-19. This study will determine whether non-invasive urinalysis is useful in assessing and predicting the severity or clinical course of patients with COVID-19.
详细描述
This study will conduct to elucidate the following clinical question;
- if the single urinary biomarker or the combination of urinary biomarkers will clarify the risk of COVID-19 confirmed mild cases. These biomarkers must be warranted to clinical use based on the evaluation by either CE or PMDA or FDA. Examination should be done within 72 h after the start of COVID-19.
- if above addressed biomarker can classify the effectiveness of therapy directed to COVID-19.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •COVID-19 confirmed cases by qPCR exam or equivalent.
- •Those who agreed to join this study
- •Those who received treatment at NCGM, affiliated hospital and institute including accommodation facilities for observational purposes.
排除标准
- •Age less than 20
- •Those who do not have smart phone (no personal contract)
- •eGFR less than 30
- •Any pre-existing illness with fever, weakness, or respiratory difficulties, Pregnancy or breastfeeding.
- •Doctors' judgements to inappropriate for inclusion
结局指标
主要结局
Risk Stratification of COVID-19 Participants Using Urine Biomarkers
时间窗: 10 days after starting the initial examination.
Urine L-FABP will be measured to detect the risk in COVID-19 confirmed cases focusing to no symptom, mild case, and moderate case. Urine beta2 microglobulin will be measured to detect the risk in COVID-19 confirmed cases. Urine L-FABP and beta2 microgloburin will be combined to examine the improvement on risk classification. The risk to develop hypoxic condition, adopted from NEJM 382:1787, 2020 (PMID: 32187464), will be pre-determined by single or dual urine biomarkers using definite cut-off values.
Prediction of COVID-19 Treatment by Urine L-FABP
时间窗: 14 days after starting the initial intervention.
The treatment efficacy of a certain specific treatment (ex. dexamethasone, tocilizumab, remdesivir, ivermectin, favipiravir, Hydroxychloroquine, etc) to COVID-19 will be predicted through the initial urine L-FABP level in mild to moderate cases.
次要结局
- Increase of O2 support, hospital days, worsening of chest X-ray and CT, and survival rate, at 14 and/or 30 days.(30 days after starting the initial examination.)
- Comparison of Risk Stratification with Other Biomarkers(7 days and 10 days after starting the initial examination.)
研究者
Eisei Noiri, MD, PhD, FASN
Director General, National Center Biobank Network
National Center for Global Health and Medicine, Japan