NCT04681040

Risk Stratification of COVID-19 Using Urine Biomarkers

Monitoring of COVID-19 Using Urine POC Kit

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 964 (actual)
• Sponsor: National Center for Global Health and Medicine, Japan · Other Government
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

This study will conduct to elucidate the following clinical question; 1. 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. 2. if above addressed biomarker can classify the effectiveness of therapy directed to COVID-19.

Conditions

• Covid19
• Urine
• Biomarker
• Acute Respiratory Failure With Hypoxia

Timeline

• Start date: 2020-09-15
• Primary completion: 2024-02-14
• Completion: 2024-03-25
• First posted: 2020-12-23
• Last updated: 2024-03-27

Locations

7 sites across 5 countries: United States, Brazil, Denmark, Japan, Philippines