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
1 other identifier
observational
600
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2020
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 30, 2020
CompletedFirst Submitted
Initial submission to the registry
April 17, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 24, 2020
CompletedFirst Posted
Study publicly available on registry
April 29, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2020
CompletedApril 30, 2020
April 1, 2020
25 days
April 17, 2020
April 29, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
ACE2 expression in patients with COVID-19 infection
6 months
Study Arms (3)
Symptomatic Patients
Patients who had symptoms related to COVID-19 infection
Health people
Healthy people who never had syntomps related to COVID-19 infection
Asyntomatic Individuals
Asyntomatic people to recruit after the restriction have ended
Interventions
Qualitative test to aid in the diagnosis of COVID-19 novel coronavirus
Eligibility Criteria
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.
You may qualify if:
- adult patients (\> 18 years old)
You may not qualify if:
- inability to understand and want;
- mentally incapacitated.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
AO San Paolo
Milan, IT, 20142, Italy
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Full Professor
Study Record Dates
First Submitted
April 17, 2020
First Posted
April 29, 2020
Study Start
March 30, 2020
Primary Completion
April 24, 2020
Study Completion
September 1, 2020
Last Updated
April 30, 2020
Record last verified: 2020-04