Risk Stratification of COVID-19 Using Urine Biomarkers
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|ClinicalTrials.gov Identifier: NCT04681040|
Recruitment Status : Recruiting
First Posted : December 23, 2020
Last Update Posted : March 15, 2021
|Condition or disease|
|Covid19 Urine Biomarker Acute Respiratory Failure With Hypoxia|
This study will conduct to elucidate the following clinical question;
- 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.
- if above addressed biomarker can classify the effectiveness of therapy directed to COVID-19.
|Study Type :||Observational|
|Estimated Enrollment :||1000 participants|
|Official Title:||Monitoring of COVID-19 Using Urine POC Kit|
|Actual Study Start Date :||December 19, 2020|
|Estimated Primary Completion Date :||March 31, 2022|
|Estimated Study Completion Date :||August 31, 2023|
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.
- Risk Stratification of COVID-19 Participants Using Urine Biomarkers [ Time Frame: 10 days after starting the initial examination. ]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.
- Prediction of COVID-19 Treatment by Urine L-FABP [ Time Frame: 14 days after starting the initial intervention. ]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.
- Increase of O2 support, hospital days, worsening of chest X-ray and CT, and survival rate, at 14 and/or 30 days. [ Time Frame: 30 days after starting the initial examination. ]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.
- Comparison of Risk Stratification with Other Biomarkers [ Time Frame: 7 days and 10 days after starting the initial examination. ]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.
Biospecimen Retention: Samples Without DNA
- Serum and plasma biomarkers of inflammation / cytokine storm, coagulation, and ischemia / organ injury.
- Urine L-FABP, Urine beta2 microgloburin.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04681040
|Contact: Eisei Noiri, M.D., Ph.D.||+firstname.lastname@example.org|
|Contact: Daisuke Katagiri, M.D., Ph.D.||+email@example.com|
|United States, Maryland|
|MD Mount Sinai||Recruiting|
|Baltimore, Maryland, United States, 21215|
|Contact: Paul A Gurbel, MD|
|Hospital das Clinicas Ribeirao Preto||Recruiting|
|Ribeirão Preto, San Paulo, Brazil|
|Contact: Benedito Fonseca, MD.|
|Contact: Adriana Ferreira (16) 3315 3376 firstname.lastname@example.org|
|Danish National Biobank||Not yet recruiting|
|Contact: Estrid Høgdall, Ph.D.|
|Shonan General Hospital||Not yet recruiting|
|Kamakura, Kanagawa, Japan, 247-8533|
|Contact: Takayasu Ohtake, M.D.|
|National Center Global Health and Medicine||Recruiting|
|Shinjuku, Tokyo, Japan, 16208655|
|Contact: Daisuke Katagiri, M.D., Ph.D. email@example.com|
|Yamanashi Prefectural Central Hospital||Recruiting|
|Kōfu, Yamanashi, Japan, 400-8506|
|Contact: Yoshihiro Miyashita, M.D.|
|Contact: Marianne Nina, M.D.|
|Principal Investigator:||Eisei Noiri, M.D., Ph.D.||National Center for Global Health and Medicine|