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| ID | Type | Description | Link |
|---|---|---|---|
| 20he0822003j0001 | Other Grant/Funding Number | AMED |
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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.
This study will conduct to elucidate the following clinical question;
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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COVID-19 confirmed case without severe symptoms.
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| Name | Affiliation | Role |
|---|---|---|
| Eisei Noiri, M.D., Ph.D. | National Center for Global Health and Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MD Mount Sinai | Baltimore | Maryland | 21215 | United States | ||
| Hospital das Clinicas Ribeirao Preto |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32766565 | Background | 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. | |
| 19019918 |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| 30 days after starting the initial examination. |
| 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. |
| Ribeirão Preto |
| São Paulo |
| Brazil |
| Danish National Biobank | Copenhagen | Denmark |
| Shonan General Hospital | Kamakura | Kanagawa | 247-8533 | Japan |
| National Center Global Health and Medicine | Shinjuku | Tokyo | 16208655 | Japan |
| Yamanashi Prefectural Central Hospital | Kofu | Yamanashi | 400-8506 | Japan |
| Unilab Group | Manila | Philippines |
| 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. |
| 17942962 | 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. |
| 20736829 | 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. |
| 34250193 | 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. |
| 36910457 | 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. |
| 38400935 | 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. |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |