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Clinical Trials/NCT04367402
NCT04367402
Unknown
Not Applicable

COST (COvid STudio) ACTION: Study for the Evaluation of Specific Antibodies Anti Covid-19 Linked to Covid-19 Infection, Symptoms and Genetic Expression of ACE2 Polymorphisms in Patients

Azienda Ospedaliera San Paolo1 site in 1 country600 target enrollmentMarch 30, 2020
ConditionsCOVID-19

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
COVID-19
Sponsor
Azienda Ospedaliera San Paolo
Enrollment
600
Locations
1
Primary Endpoint
Retrospective study on individuals with or without symptoms to verify the reliability of a prognostic/diagnostic test based on IgM/IgG analysis.
Last Updated
6 years ago

Overview

Brief Summary

The aims of this study is to define the genetic bases of COVID-19 related disease heterogeneity in frail population, to carry out a retrospective study on individuals w/wo symptoms to verify the reliability of a prognostic/diagnostic test based on IgM/IgG analysis and on the presence of genetic profiling and to explore the therapeutic potential of the modulation of ACE2 expression.

Registry
clinicaltrials.gov
Start Date
March 30, 2020
End Date
September 2020
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Azienda Ospedaliera San Paolo
Responsible Party
Principal Investigator
Principal Investigator

Stefano Centanni

Full Professor

Azienda Ospedaliera San Paolo

Eligibility Criteria

Inclusion Criteria

  • adult patients (\> 18 years old)

Exclusion Criteria

  • inability to understand and want;
  • mentally incapacitated.

Outcomes

Primary Outcomes

Retrospective study on individuals with or without symptoms to verify the reliability of a prognostic/diagnostic test based on IgM/IgG analysis.

Time Frame: 6 months

BioMedomics Rapid IgM-IgG Combined Antibody Test for COVID-19 is immunochromatography based. The test card contains colloidal gold-labeled recombinant novel coronavirus antigen and quality control antibody colloidal gold marker, two detection lines (G and M lines) and one quality control line (C) fixed on a nitrocellulose membrane. When 10 microL of test sample is added to the sample well of the test cassette, the sample will move forward along the test card via capillary action. If the sample contains IgM antibody, the antibody will bind to the colloidal gold-labeled novel coronavirus antigen. The antibody/antigen complex will be captured by the anti-human IgM antibody immobilized on the membrane, forming a red M line and indicating a positive result for the IgM antibody. If the sample contains IgG antibodies, the same thing happens, forming a red G line and indicating a positive result for the IgG antibody. If neither antibody is present, a negative result is displayed.

Secondary Outcomes

  • ACE2 expression in patients with COVID-19 infection(6 months)

Study Sites (1)

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