Risk Stratification of COVID-19 Using Urine Biomarkers

NCT04681040 | Active Not Recruiting DMC

• 2 other identifiers: NCGM-G-003654-0020he0822003j0001
• Study Type: observational
• Target: 964
• Locations: 5 countries
• Sites: 7

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.

Conditions

Covid19; Urine; Biomarker; Acute Respiratory Failure With Hypoxia

Keywords

L-type Fatty Acid-binding Protein, beta 2 microglobulin

Outcome Measures

Primary Outcomes (2)

• 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.

• 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 Outcomes (2)

• 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.

• Comparison of Risk Stratification with Other Biomarkers

  7 days and 10 days after starting the initial examination.

Study Arms (1)

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.

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

COVID-19 confirmed case without severe symptoms.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Center for Global Health and Medicine, Japan: lead

Study Sites (7)

MD Mount Sinai

Baltimore, Maryland, 21215, United States

Location

Hospital das Clinicas Ribeirao Preto

Ribeirão Preto, São Paulo, Brazil

Location

Danish National Biobank

Copenhagen, Denmark

Location

Shonan General Hospital

Kamakura, Kanagawa, 247-8533, Japan

Location

National Center Global Health and Medicine

Shinjuku, Tokyo, 16208655, Japan

Location

Yamanashi Prefectural Central Hospital

Kofu, Yamanashi, 400-8506, Japan

Location

Unilab Group

Manila, Philippines

Location

Related Publications (7)

• 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.

  PMID: 32766565 BACKGROUND

• 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.

  PMID: 19019918 BACKGROUND

• 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.

  PMID: 17942962 BACKGROUND

• 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.

  PMID: 20736829 BACKGROUND

• 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.

  PMID: 34250193 BACKGROUND

• 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.

  PMID: 36910457 BACKGROUND

• 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.

  PMID: 38400935 BACKGROUND

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.

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Eisei Noiri, M.D., Ph.D.

  National Center for Global Health and Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director General, National Center Biobank Network

Study Record Dates

• First Submitted: December 19, 2020
• First Posted: December 23, 2020
• Study Start: September 15, 2020
• Primary Completion: February 14, 2024
• Study Completion: March 25, 2024
• Last Updated: March 27, 2024

Record last verified: 2024-03

Locations

DK (1); PH (1); JP (3); US (1); BR (1)