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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) (COST ACTION)

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ClinicalTrials.gov Identifier: NCT04367402
Recruitment Status : Recruiting
First Posted : April 29, 2020
Last Update Posted : April 30, 2020
Sponsor:
Information provided by (Responsible Party):
Stefano Centanni, Azienda Ospedaliera San Paolo

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.

Condition or disease Intervention/treatment
COVID-19 Other: BioMedomics COVID-19 IgM-IgG Rapid Test

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Study Type : Observational
Estimated Enrollment : 600 participants
Observational Model: Case-Control
Time Perspective: Retrospective
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
Actual Study Start Date : March 30, 2020
Actual Primary Completion Date : April 24, 2020
Estimated Study Completion Date : September 2020

Group/Cohort Intervention/treatment
Symptomatic Patients
Patients who had symptoms related to COVID-19 infection
Other: BioMedomics COVID-19 IgM-IgG Rapid Test
Qualitative test to aid in the diagnosis of COVID-19 novel coronavirus

Health people
Healthy people who never had syntomps related to COVID-19 infection
Other: BioMedomics COVID-19 IgM-IgG Rapid Test
Qualitative test to aid in the diagnosis of COVID-19 novel coronavirus

Asyntomatic Individuals
Asyntomatic people to recruit after the restriction have ended
Other: BioMedomics COVID-19 IgM-IgG Rapid Test
Qualitative test to aid in the diagnosis of COVID-19 novel coronavirus




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. ACE2 expression in patients with COVID-19 infection [ Time Frame: 6 months ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Sample size: 200 symptomatic patients with no other characteristics; 200 health people with no other characteristics; 200 asymptomatic individuals to recruit after the restrictions have ended with no other characteristics.
Criteria

Inclusion Criteria:

  • adult patients (> 18 years old)

Exclusion Criteria:

  • inability to understand and want;
  • mentally incapacitated.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04367402


Contacts
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Contact: Stefano Centanni, Full Professor 0281843025 stefano.centanni@unimi.it

Locations
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Italy
AO San Paolo Recruiting
Milan, IT, Italy, 20142
Contact: Stefano Centanni, Full Professor    0281843025    stefano.centanni@unimi.it   
Sponsors and Collaborators
Azienda Ospedaliera San Paolo
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Responsible Party: Stefano Centanni, Full Professor, Azienda Ospedaliera San Paolo
ClinicalTrials.gov Identifier: NCT04367402    
Other Study ID Numbers: 2020/ST/057
First Posted: April 29, 2020    Key Record Dates
Last Update Posted: April 30, 2020
Last Verified: April 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Infection