Risk Stratification of COVID-19 Using Urine Biomarkers (NCT04681040) | Clinical Trial Compass
UnknownNot Applicable
Risk Stratification of COVID-19 Using Urine Biomarkers
United States, Brazil, Denmark964 participantsStarted 2020-09-15
Plain-language 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. 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.
Who can participate
Age range
20 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Risk Stratification of COVID-19 Participants Using Urine Biomarkers
Timeframe: 10 days after starting the initial examination.
2
Prediction of COVID-19 Treatment by Urine L-FABP
Timeframe: 14 days after starting the initial intervention.
Trial details
NCT IDNCT04681040
SponsorNational Center for Global Health and Medicine, Japan