Risk Stratification of COVID-19 Using Urine Biomarkers

Active, not recruiting

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

• Registration Number: NCT04681040
• Lead Sponsor: National Center for Global Health and Medicine, Japan

Brief 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.

Study Timeline

• Study Start: 2020-09-15
• Study First Submitted: 2020-12-19
• Study First Submitted QC: 2020-12-22
• Study First Posted: 2020-12-23
• Primary Completion: 2024-02-14
• Status Verified: 2024-03
• Study Completion: 2024-03-25
• Last Update Submitted: 2024-03-25
• Last Update Posted: 2024-03-27

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 964

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Risk Stratification of COVID-19 Participants Using Urine Biomarkers	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	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.

Secondary Outcome Measures

Name	Time	Method
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.	Applicability of urine L-FABP and beta2 microgloburin will be measured. Single urine biomarker (L-FABP or beta2 microgloburin) or those combination will be evaluated for predictions such as; i) increase of O2 \& respiratory supports, ii) increase of hospital days, iii) worsening level of chest X-ray \& CT, and iv) survival rate and SOFA in ICU. At 14 and/or 30 days after the inclusion these clinical parameters will be evaluated based on the cut off value of single urine biomarker (L-FABP or beta2 microgloburin) and those aggregates.
Comparison of Risk Stratification with Other Biomarkers	7 days and 10 days after starting the initial examination.	Urine L-FABP and beta2 microgloburin will be measured. Single urine biomarker (L-FABP or beta2 microgloburin) or those combination will be compared with d-Dimer and IL-6 for the risk evaluation of COVID-19 in te scope of Outcome 3.

Trial Locations

Locations (7)

Shonan General Hospital; 🇯🇵 Kamakura, Kanagawa, Japan

Hospital das Clinicas Ribeirao Preto; 🇧🇷 Ribeirão Preto, San Paulo, Brazil

Danish National Biobank; 🇩🇰 København, Denmark

MD Mount Sinai; 🇺🇸 Baltimore, Maryland, United States

National Center Global Health and Medicine; 🇯🇵 Shinjuku, Tokyo, Japan

Yamanashi Prefectural Central Hospital; 🇯🇵 Kōfu, Yamanashi, Japan

Unilab Group; 🇵🇭 Manila, Philippines