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Covid19NCT04681040

Risk Stratification of COVID-19 Using Urine Biomarkers

An observational study of Covid19 and Urine, run by National Center for Global Health and Medicine, Japan at 7 sites in 5 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Covid19, Urine, Biomarker
How many people
964 participants
Where
7 sitesin 5 countries
Study dates
15 Sep 2020to 25 Mar 2024
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: COVID-19 confirmed case without severe symptoms.

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

7 sites in 5 countries.

7 sites in 5 countries

Japan3 sites

  • Shonan General Hospital

    Kamakura, Kanagawa, 247-8533

  • Yamanashi Prefectural Central Hospital

    Kofu, Yamanashi, 400-8506

  • National Center Global Health and Medicine

    Shinjuku, Tokyo, 16208655

Other trials in Japan

United States1 site

  • MD Mount Sinai

    Baltimore, Maryland, 21215

Other trials in United States

Brazil1 site

  • Hospital das Clinicas Ribeirao Preto

    Ribeirão Preto, São Paulo

Other trials in Brazil

Denmark1 site

  • Danish National Biobank

    Copenhagen

Other trials in Denmark

Philippines1 site

  • Unilab Group

    Manila

Other trials in Philippines

About this study

Official title: 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.

Read the 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.
Keywords
L-type Fatty Acid-binding Protein, beta 2 microglobulin
Medical subject headings
COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT04681040
Study groupRoleWhat they receive
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 being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 10 days after starting the initial examination.

  2. 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.

    Measured: 14 days after starting the initial intervention.

Secondary outcomes (2)

  1. 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.

    Measured: 30 days after starting the initial examination.

  2. 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.

    Measured: 7 days and 10 days after starting the initial examination.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Dec 2020
  2. Study start15 Sep 2020
  3. Primary completion14 Feb 2024
  4. Study completion25 Mar 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
964 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04681040
Sponsor's protocol ID
NCGM-G-003654-00
Other IDs
20he0822003j0001
Status last verified
Mar 2024
First submitted
19 Dec 2020
Last updated
27 Mar 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 32766565

  • 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.

    PubMed 19019918

  • 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.

    PubMed 17942962

  • 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.

    PubMed 20736829

  • 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.

    PubMed 34250193

  • 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.

    PubMed 36910457

  • 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.

    PubMed 38400935

Questions about this trial

What is this clinical trial studying?

An observational study of Covid19 and Urine, run by National Center for Global Health and Medicine, Japan at 7 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 27 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in Japan, United States, Brazil, Denmark, Philippines. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Risk Stratification of COVID-19 Participants Using Urine Biomarkers (time frame: 10 days after starting the initial examination.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04681040, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2024.

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