SuPAR in Adult Patients With Covid-19

NCT04590794 | Completed DMC

• 1 other identifier: UTHDA-AC03
• Study Type: observational
• Target: 767
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

covid 19; organ injury; outcome

Outcome Measures

Primary Outcomes (1)

• respiratory complications

  need of non-invasive ventilation (CPAP-BiPAP), hi-flow nasal oxygen, or mechanical ventilation

  Up to 8 weeks

Secondary Outcomes (5)

• Hypotension

  Up to 8 weeks

• need for vasoactive drugs

  Up to 8 weeks

• Number of participants with acute new cardiovascular disorder

  Up to 8 weeks

• Number of participants with organ failure

  Up to 8 weeks

• Number of participants with overall survival up to 8 weeks

  Up to 8 weeks

Study Arms (1)

covid 19

Patients admitted with covid 19

Diagnostic Test: Soluble Urokinase Plasminogen Activator Receptor

Interventions

Soluble Urokinase Plasminogen Activator Receptor DIAGNOSTIC_TEST

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.

Also known as: suPAR

covid 19

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Consecutive adult patients who are admitted to the Hospital due to Covid-19

You may qualify if:

• 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

You may not qualify if:

• patients with confirmed SARS-CoV-2 infection who will not be primarily admitted for COVID-19
• patients with incomplete data

Sponsors & Collaborators

• University of Thessaly: lead

Study Sites (1)

University Hospital of Larisa, Department of Anesthesiology

Larissa, Thessaly, 41110, Greece

Location

Related Publications (3)

• 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.

  PMID: 32613288 BACKGROUND

• 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.

  PMID: 32963090 BACKGROUND

• 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.

  PMID: 32291542 BACKGROUND

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Athanasios Chalkias, PhD

  University of Thessaly

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asst. Professor of Anesthesiology

Study Record Dates

• First Submitted: October 14, 2020
• First Posted: October 19, 2020
• Study Start: October 11, 2020
• Primary Completion: June 8, 2021
• Study Completion: June 8, 2021
• Last Updated: October 25, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)