Covid19 Clinical Trial
Official title:
Monitoring of COVID-19 Using Urine POC Kit
Verified date | March 2024 |
Source | National Center for Global Health and Medicine, Japan |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
National Center for Global Health and Medicine, Japan |
United States, Brazil, Denmark, Japan, Philippines,
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
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. |
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