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 (COST ACTION)

COVID-19 Clinical Trial

— COST ACTION  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04367402
• Other study ID #: 2020/ST/057
• Status: Recruiting
• Start date: March 30, 2020
• Est. completion date: September 2020

Study information

• Verified date: April 2020
• Source: Azienda Ospedaliera San Paolo
• Contact: Stefano Centanni, Full Professor
• Phone: 0281843025
• Email: stefano.centanni[@]unimi.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: September 2020
• Est. primary completion date: April 24, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• adult patients (> 18 years old)

Exclusion Criteria:

• inability to understand and want;

• mentally incapacitated.

Related Conditions & MeSH terms

• COVID-19
• Infection

Intervention

Other:
• BioMedomics COVID-19 IgM-IgG Rapid Test
Qualitative test to aid in the diagnosis of COVID-19 novel coronavirus

Locations

Country	Name	City	State
Italy	AO San Paolo	Milan	IT

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliera San Paolo

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Retrospective study on individuals with or without symptoms to verify the reliability of a prognostic/diagnostic test based on IgM/IgG analysis.	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.	6 months
Secondary	ACE2 expression in patients with COVID-19 infection	By an in silico analysis, we found 2 missense variants in ACE2 gene annotated at residues 82 (rs766996587) and 355 (rs961360700) involved in PPIs with MAF<0.01. Variants in other residues of the ACE2 may affect protein structure and/or activity/localization, influence the binding of the spike protein and thus the virus ability to enter the respiratory tract.In light of its relevance in cell entry, pharmacological approaches aimed at modulating ACE2 expression, through the modulation of SIRT1 activity in the lung or by selective oligo antisense treatment, should help in counteracting COVID-19 infection. Annotated SNPs evaluation of the TMPRSS2 gene showed 4 exonic common polymorphisms (MAF>1%); of these, rs12329760 is a missense variant in the SRCR domain mediating PPI and ligand binding. Common SNPs are at the 3'UTR, possibly involved in regulating mRNA stability and several rare variants mapped in exons encoding the peptidase domain, potentially affecting protein activity.	6 months