Clinical trial NCT04681040: Risk Stratification of COVID-19 Using Urine Biomarkers
Official title: Monitoring of COVID-19 Using Urine POC Kit
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Covid19
Urine
Biomarker
Acute Respiratory Failure With Hypoxia
Keywords: L-type Fatty Acid-binding Protein, beta 2 microglobulin
Lead sponsor: National Center for Global Health and Medicine, Japan
Sponsor class: OTHER_GOV
First posted: 2020-12-23
Enrollment: 964
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: COVID-19 confirmed case without severe symptoms.

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.

Eligibility 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

Primary outcomes:
measure: Risk Stratification of COVID-19 Participants Using Urine Biomarkers
timeFrame: 10 days after starting the initial examination.
measure: Prediction of COVID-19 Treatment by Urine L-FABP
timeFrame: 14 days after starting the initial intervention.
Secondary outcomes:
measure: Increase of O2 support, hospital days, worsening of chest X-ray and CT, and survival rate, at 14 and/or 30 days.
timeFrame: 30 days after starting the initial examination.
measure: Comparison of Risk Stratification with Other Biomarkers
timeFrame: 7 days and 10 days after starting the initial examination.
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: MD Mount Sinai
state: Maryland
city: Ribeirão Preto
country: Brazil
facility: Hospital das Clinicas Ribeirao Preto
state: San Paulo
city: København
country: Denmark
facility: Danish National Biobank
city: Kamakura
country: Japan
facility: Shonan General Hospital
state: Kanagawa
city: Shinjuku
country: Japan
facility: National Center Global Health and Medicine
state: Tokyo
city: Kōfu
country: Japan
facility: Yamanashi Prefectural Central Hospital
state: Yamanashi
city: Manila
country: Philippines
facility: Unilab Group
Study officials:
affiliation: National Center for Global Health and Medicine
name: Eisei Noiri, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Katagiri D, Ishikane M, Asai Y, Kinoshita N, Ota M, Moriyama Y, Ide S, Nakamura K, Nakamoto T, Nomoto H, Akiyama Y, Miyazato Y, Suzuki T, Okuhama A, Kanda K, Wakimoto Y, Morioka S, Saito S, Yamamoto K, Ujiie M, Hayakawa K, Kustuna S, Yanagawa Y, Terada J, Takasaki J, Izumi S, Hojo M, Hinoshita F, Sugiyama M, Noiri E, Mizokami M, Ohmagari N, Sugiyama H. Evaluation of Coronavirus Disease 2019 Severity Using Urine Biomarkers. Crit Care Explor. 2020 Jul 31;2(8):e0170. doi: 10.1097/CCE.0000000000000170. eCollection 2020 Aug.
citation: Noiri E, Doi K, Negishi K, Tanaka T, Hamasaki Y, Fujita T, Portilla D, Sugaya T. Urinary fatty acid-binding protein 1: an early predictive biomarker of kidney injury. Am J Physiol Renal Physiol. 2009 Apr;296(4):F669-79. doi: 10.1152/ajprenal.90513.2008. Epub 2008 Nov 19.
citation: Yamamoto T, Noiri E, Ono Y, Doi K, Negishi K, Kamijo A, Kimura K, Fujita T, Kinukawa T, Taniguchi H, Nakamura K, Goto M, Shinozaki N, Ohshima S, Sugaya T. Renal L-type fatty acid--binding protein in acute ischemic injury. J Am Soc Nephrol. 2007 Nov;18(11):2894-902. doi: 10.1681/ASN.2007010097. Epub 2007 Oct 17.
citation: Doi K, Noiri E, Sugaya T. Urinary L-type fatty acid-binding protein as a new renal biomarker in critical care. Curr Opin Crit Care. 2010 Dec;16(6):545-9. doi: 10.1097/MCC.0b013e32833e2fa4.
citation: Tantry US, Bliden KP, Cho A, Walia N, Dahlen JR, Ens G, Traianova M, Jerjian C, Usman A, Gurbel PA. First Experience Addressing the Prognostic Utility of Novel Urinary Biomarkers in Patients With COVID-19. Open Forum Infect Dis. 2021 May 26;8(7):ofab274. doi: 10.1093/ofid/ofab274. eCollection 2021 Jul.
citation: Katagiri D, Asai Y, Ohmagari N, Ishikane M, Hikida S, Iwamoto N, Nagashima M, Suzuki M, Takano H, Takasaki J, Hojo M, Sugiyama H, Tokunaga K, Miyashita Y, Omata M, Ohata K, Bliden KP, Tantry US, Dahlen JR, Sugaya T, Gurbel PA, Noiri E. Urinary L-Type Fatty Acid-Binding Protein Predicts Oxygen Demand of COVID-19 in Initially Mild Cases. Crit Care Explor. 2023 Mar 9;5(3):e0873. doi: 10.1097/CCE.0000000000000873. eCollection 2023 Mar.
citation: Noiri E, Katagiri D, Asai Y, Sugaya T, Tokunaga K. Urine oxygenation predicts COVID-19 risk. Clin Exp Nephrol. 2024 Jul;28(7):608-616. doi: 10.1007/s10157-023-02456-5. Epub 2024 Feb 24.