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SuPAR in Adult Patients With Covid-19

NCT04590794 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 767

Last updated 2021-10-25

No results posted yet for this study

Summary

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.

Conditions

  • Covid19

Interventions

DIAGNOSTIC_TEST

Soluble Urokinase Plasminogen Activator Receptor

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), which is based on a simplified double monoclonal antibody sandwich ELISA assay whereby samples and peroxidase-conjugated anti-suPAR are first mixed together and then incubated in anti-suPAR pre-coated micro wells. The recombinant suPAR standards of the kit are calibrated against healthy human blood donor samples. suPAR concentrations are determined as ng/mL plasma.

Sponsors & Collaborators

  • University of Thessaly

    lead OTHER

Principal Investigators

  • Athanasios Chalkias, PhD · University of Thessaly

Eligibility

Min Age
18 Years
Max Age
120 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-11
Primary Completion
2021-06-08
Completion
2021-06-08

Countries

  • Greece

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04590794 on ClinicalTrials.gov