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; 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.
Study Type
OBSERVATIONAL
Enrollment
964
MD Mount Sinai
Baltimore, Maryland, United States
Hospital das Clinicas Ribeirao Preto
Ribeirão Preto, São Paulo, Brazil
Danish National Biobank
Copenhagen, Denmark
Shonan General Hospital
Kamakura, Kanagawa, Japan
National Center Global Health and Medicine
Shinjuku, Tokyo, Japan
Yamanashi Prefectural Central Hospital
Kofu, Yamanashi, Japan
Unilab Group
Manila, Philippines
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.
Time frame: 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.
Time frame: 14 days after starting the initial intervention.
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.
Time frame: 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.
Time frame: 7 days and 10 days after starting the initial examination.
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