Risk Stratification of COVID-19 Using Urine Biomarkers

Covid19 Clinical Trial

Official title:

Monitoring of COVID-19 Using Urine POC Kit

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04681040
• Other study ID #: NCGM-G-003654-00
• Secondary ID: 20he0822003j0001
• Status: Active, not recruiting
• Start date: September 15, 2020
• Est. completion date: March 25, 2024

Study information

• Verified date: March 2024
• Source: National Center for Global Health and Medicine, Japan
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 964
• Est. completion date: March 25, 2024
• Est. primary completion date: February 14, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Respiratory Failure With Hypoxia
• Biomarker
• COVID-19
• Covid19
• Hypoxia
• Respiratory Insufficiency
• Urine

Locations

Country	Name	City	State
Brazil	Hospital das Clinicas Ribeirao Preto	Ribeirão Preto	San Paulo
Denmark	Danish National Biobank	København
Japan	Shonan General Hospital	Kamakura	Kanagawa
Japan	Yamanashi Prefectural Central Hospital	Kofu	Yamanashi
Japan	National Center Global Health and Medicine	Shinjuku	Tokyo
Philippines	Unilab Group	Manila
United States	MD Mount Sinai	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
National Center for Global Health and Medicine, Japan

Countries where clinical trial is conducted

United States,  Brazil,  Denmark,  Japan,  Philippines, 

References & Publications (7)

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. — View 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. — View 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. — View 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. — View Citation

Noiri E, Katagiri D, Asai Y, Sugaya T, Tokunaga K. Urine oxygenation predicts COVID-19 risk. Clin Exp Nephrol. 2024 Feb 24. doi: 10.1007/s10157-023-02456-5. Online ahead of print. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Risk Stratification of COVID-19 Participants Using Urine Biomarkers	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.
Primary	Prediction of COVID-19 Treatment by Urine L-FABP	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	Increase of O2 support, hospital days, worsening of chest X-ray and CT, and survival rate, at 14 and/or 30 days.	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.
Secondary	Comparison of Risk Stratification with Other Biomarkers	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.