Risk Stratification of COVID-19 Using Urine Biomarkers

National Center for Global Health and Medicine, Japan

Status: Active, not recruiting

Conditions: Biomarker; Urine; Covid19; Acute Respiratory Failure With Hypoxia

Study type: Observational

Funder types: Other

Identifiers

NCT04681040

20he0822003j0001 (Other Grant/Funding Number)

NCGM-G-003654-00

Details and patient eligibility

About

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.

Full 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.

Enrollment: 964 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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

Trial design

964 participants in 1 patient group

UrBMC19 Group (International Cooperative Group)

Description:

The examination of urine for mild pre-diagnosed COVID-19 cases are conducted to evaluate the risk classification and detect the effectiveness of early intervention by COVID-19 treatment such as dexamethasone, chloroquine, remdesivir, ivermectin, actemra, and so forth within the period of 14 days after starting the intervention.