Risk Stratification of COVID-19 Using Urine Biomarkers

March 25, 2024 updated by: Eisei Noiri, MD, PhD, FASN, National Center for Global Health and Medicine, Japan

Monitoring of COVID-19 Using Urine POC Kit

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.

Study Overview

Status

Active, not recruiting

Conditions

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 Type

Observational

Enrollment (Actual)

964

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • San Paulo
      • Ribeirão Preto, San Paulo, Brazil
        • Hospital das Clinicas Ribeirao Preto
  • Denmark
      • København, Denmark
        • Danish National Biobank
  • Japan
    • Kanagawa
      • Kamakura, Kanagawa, Japan, 247-8533
        • Shonan General Hospital
    • Tokyo
      • Shinjuku, Tokyo, Japan, 16208655
        • National Center Global Health and Medicine
    • Yamanashi
      • Kōfu, Yamanashi, Japan, 400-8506
        • Yamanashi Prefectural Central Hospital
  • Philippines
      • Manila, Philippines
        • Unilab Group
  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21215
        • MD Mount Sinai

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

COVID-19 confirmed case without severe symptoms.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
UrBMC19 Group (International Cooperative Group)
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Risk Stratification of COVID-19 Participants Using Urine Biomarkers
Time Frame: 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.
10 days after starting the initial examination.
Prediction of COVID-19 Treatment by Urine L-FABP
Time Frame: 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.
14 days after starting the initial intervention.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Increase of O2 support, hospital days, worsening of chest X-ray and CT, and survival rate, at 14 and/or 30 days.
Time Frame: 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.
30 days after starting the initial examination.
Comparison of Risk Stratification with Other Biomarkers
Time Frame: 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.
7 days and 10 days after starting the initial examination.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Center for Global Health and Medicine, Japan

Investigators

  • Principal Investigator: Eisei Noiri, M.D., Ph.D., National Center for Global Health and Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 15, 2020

Primary Completion (Actual)

February 14, 2024

Study Completion (Estimated)

March 25, 2024

Study Registration Dates

First Submitted

December 19, 2020

First Submitted That Met QC Criteria

December 22, 2020

First Posted (Actual)

December 23, 2020

Study Record Updates

Last Update Posted (Actual)

March 27, 2024

Last Update Submitted That Met QC Criteria

March 25, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCGM-G-003654-00
  • 20he0822003j0001 (Other Grant/Funding Number: AMED)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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