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Risk Stratification of COVID-19 Using Urine Biomarkers

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ClinicalTrials.gov Identifier: NCT04681040
Recruitment Status : Recruiting
First Posted : December 23, 2020
Last Update Posted : March 15, 2021
Sponsor:
Information provided by (Responsible Party):
Eisei Noiri, National Center for Global Health and Medicine, Japan

Study Description
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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.

Condition or disease
Covid19 Urine Biomarker Acute Respiratory Failure With Hypoxia

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 Design
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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Monitoring of COVID-19 Using Urine POC Kit
Actual Study Start Date : December 19, 2020
Estimated Primary Completion Date : March 31, 2022
Estimated Study Completion Date : August 31, 2023

Resource links provided by the National Library of Medicine


Groups and Cohorts
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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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.


Biospecimen Retention:   Samples Without DNA
  1. Serum and plasma biomarkers of inflammation / cytokine storm, coagulation, and ischemia / organ injury.
  2. Urine L-FABP, Urine beta2 microgloburin.

Eligibility Criteria
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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
COVID-19 confirmed case without severe symptoms.
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04681040


Contacts
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Contact: Eisei Noiri, M.D., Ph.D. +81352736891 enoiri@hosp.ncgm.go.jp
Contact: Daisuke Katagiri, M.D., Ph.D. +81332027181 dkatagiri@hosp.ncgm.go.jp

Locations
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United States, Maryland
MD Mount Sinai Recruiting
Baltimore, Maryland, United States, 21215
Contact: Paul A Gurbel, MD         
Brazil
Hospital das Clinicas Ribeirao Preto Recruiting
Ribeirão Preto, San Paulo, Brazil
Contact: Benedito Fonseca, MD.         
Contact: Adriana Ferreira    (16) 3315 3376    adriana@fmrp.usp.br   
Denmark
Danish National Biobank Not yet recruiting
København, Denmark
Contact: Estrid Høgdall, Ph.D.         
Japan
Shonan General Hospital Not yet recruiting
Kamakura, Kanagawa, Japan, 247-8533
Contact: Takayasu Ohtake, M.D.         
National Center Global Health and Medicine Recruiting
Shinjuku, Tokyo, Japan, 16208655
Contact: Daisuke Katagiri, M.D., Ph.D.       dkatagiri@hosp.ncgm.go.jp   
Yamanashi Prefectural Central Hospital Recruiting
Kōfu, Yamanashi, Japan, 400-8506
Contact: Yoshihiro Miyashita, M.D.         
Philippines
Unilab Group Recruiting
Manila, Philippines
Contact: Marianne Nina, M.D.         
Sponsors and Collaborators
National Center for Global Health and Medicine, Japan
Investigators
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Principal Investigator: Eisei Noiri, M.D., Ph.D. National Center for Global Health and Medicine
More Information
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Publications:

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Responsible Party: Eisei Noiri, Director General, National Center Biobank Network, National Center for Global Health and Medicine, Japan
ClinicalTrials.gov Identifier: NCT04681040    
Other Study ID Numbers: NCGM-G-003654-00
First Posted: December 23, 2020    Key Record Dates
Last Update Posted: March 15, 2021
Last Verified: March 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Eisei Noiri, National Center for Global Health and Medicine, Japan:
L-type Fatty Acid-binding Protein, beta 2 microglobulin
Additional relevant MeSH terms:
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COVID-19
Respiratory Insufficiency
Hypoxia
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
 Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Signs and Symptoms, Respiratory