Covid19 Clinical Trial
— SPARCOLOfficial title:
A Prospective Observational Study on Assessment of the Soluble Urokinase Plasminogen Activator Receptor in Adult Patients With Covid-19
NCT number | NCT04590794 |
Other study ID # | UTHDA-AC03 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | October 11, 2020 |
Est. completion date | June 8, 2021 |
Verified date | October 2021 |
Source | University of Thessaly |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The biomarker soluble urokinase plasminogen activator receptor (suPAR) is the soluble form of the cell membrane-bound protein urokinase plasminogen activator receptor (uPAR), which is expressed mainly on immune cells, endothelial cells, and smooth muscle cells. SPARCOL is a multi-center prospective observational study aiming to investigate if suPAR measured at admission can predict the risk of future complications and mortality in adults patients with Covid-19. The study will include approximately 500 patients and will be one of the largest so far. The study has been registered at Clinical Trials.gov and has been approved by the Institutional Review Board of the University Hospital of Larisa. Consecutive adult patients (≥ 18 years ) who are admitted to the Hospital due to Covid-19 will be screened for inclusion. Participants will undergo sampling of peripheral venous blood, immediately after admission. Blood samples drawn from all patients and EDTA plasma will be stored at -80° C until later measurement. Plasma suPAR levels will be determined using the suPARnostic® ELISA assay (ViroGates, Denmark). The primary endpoint will be the presence of respiratory complications, admission to ICU, and survival at 30 days. Secondary endpoints are also included, such as organ injury, hospital length of stay, and survival. Data analysis will be based on predefined data points on a prospective data collection form.
Status | Completed |
Enrollment | 767 |
Est. completion date | June 8, 2021 |
Est. primary completion date | June 8, 2021 |
Accepts healthy volunteers | |
Gender | All |
Age group | 18 Years to 120 Years |
Eligibility | Inclusion Criteria: - age =18 years - patients hospitalized primarily for Covid 19 - confirmed SARS-CoV-2 infection diagnosed through RT-PCR test of nasopharyngeal or oropharyngeal samples - at least one blood sample collected during the hospitalization and stored for biomarker testing Exclusion Criteria: - patients with confirmed SARS-CoV-2 infection who will not be primarily admitted for COVID-19 - patients with incomplete data |
Country | Name | City | State |
---|---|---|---|
Greece | University Hospital of Larisa, Department of Anesthesiology | Larissa | Thessaly |
Lead Sponsor | Collaborator |
---|---|
University of Thessaly |
Greece,
Azam TU, Shadid HR, Blakely P, O'Hayer P, Berlin H, Pan M, Zhao P, Zhao L, Pennathur S, Pop-Busui R, Altintas I, Tingleff J, Stauning MA, Andersen O, Adami ME, Solomonidi N, Tsilika M, Tober-Lau P, Arnaoutoglou E, Keitel V, Tacke F, Chalkias A, Loosen SH, Giamarellos-Bourboulis EJ, Eugen-Olsen J, Reiser J, Hayek SS; International Study of Inflammation in COVID-19. Soluble Urokinase Receptor (SuPAR) in COVID-19-Related AKI. J Am Soc Nephrol. 2020 Nov;31(11):2725-2735. doi: 10.1681/ASN.2020060829. Epub 2020 Sep 22. — View Citation
Chalkias A, Mouzarou A, Samara E, Xanthos T, Ischaki E, Pantazopoulos I. Soluble Urokinase Plasminogen Activator Receptor: A Biomarker for Predicting Complications and Critical Care Admission of COVID-19 Patients. Mol Diagn Ther. 2020 Oct;24(5):517-521. doi: 10.1007/s40291-020-00481-8. — View Citation
Ge H, Wang X, Yuan X, Xiao G, Wang C, Deng T, Yuan Q, Xiao X. The epidemiology and clinical information about COVID-19. Eur J Clin Microbiol Infect Dis. 2020 Jun;39(6):1011-1019. doi: 10.1007/s10096-020-03874-z. Epub 2020 Apr 14. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | respiratory complications | need of non-invasive ventilation (CPAP-BiPAP), hi-flow nasal oxygen, or mechanical ventilation | Up to 8 weeks | |
Secondary | Hypotension | systolic blood pressure <90 mmHg or mean arterial pressure <65 mmHg for 3 minutes or more | Up to 8 weeks | |
Secondary | need for vasoactive drugs | need for vasoactive drugs not planned before and/or continuous infusion | Up to 8 weeks | |
Secondary | Number of participants with acute new cardiovascular disorder | Number of participants with atrial fibrillation, sustained ventricular tachycardia, supraventricular tachycardia, myocardial infarction, SPARCOL Study April 12, 2020 7 pericarditis, myocarditis, cardiogenic shock, and/or cardiac arrest | Up to 8 weeks | |
Secondary | Number of participants with organ failure | Number of participants with any organ failure | Up to 8 weeks | |
Secondary | Number of participants with overall survival up to 8 weeks | Number of participants who survive up to 8 weeks | Up to 8 weeks |
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