Ignite Creation Date:
2025-12-25 @ 3:45 AM
Ignite Modification Date:
2025-12-26 @ 2:31 AM
Study NCT ID:
NCT04367402
Status:
UNKNOWN
Last Update Posted:
2020-04-30
First Post:
2020-04-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief 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 (COST ACTION)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 600}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-03-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2020-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-04-29', 'studyFirstSubmitDate': '2020-04-17', 'studyFirstSubmitQcDate': '2020-04-28', 'lastUpdatePostDateStruct': {'date': '2020-04-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-04-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Retrospective study on individuals with or without symptoms to verify the reliability of a prognostic/diagnostic test based on IgM/IgG analysis.', 'timeFrame': '6 months', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'ACE2 expression in patients with COVID-19 infection', 'timeFrame': '6 months', 'description': "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."}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['COVID-19']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adult patients (\\> 18 years old)\n\nExclusion Criteria:\n\n* inability to understand and want;\n* mentally incapacitated.'}, 'identificationModule': {'nctId': 'NCT04367402', 'acronym': 'COST ACTION', 'briefTitle': '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)', 'organization': {'class': 'OTHER', 'fullName': 'Azienda Ospedaliera San Paolo'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': '2020/ST/057'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Symptomatic Patients', 'description': 'Patients who had symptoms related to COVID-19 infection', 'interventionNames': ['Other: BioMedomics COVID-19 IgM-IgG Rapid Test']}, {'label': 'Health people', 'description': 'Healthy people who never had syntomps related to COVID-19 infection', 'interventionNames': ['Other: BioMedomics COVID-19 IgM-IgG Rapid Test']}, {'label': 'Asyntomatic Individuals', 'description': 'Asyntomatic people to recruit after the restriction have ended', 'interventionNames': ['Other: BioMedomics COVID-19 IgM-IgG Rapid Test']}], 'interventions': [{'name': 'BioMedomics COVID-19 IgM-IgG Rapid Test', 'type': 'OTHER', 'description': 'Qualitative test to aid in the diagnosis of COVID-19 novel coronavirus', 'armGroupLabels': ['Asyntomatic Individuals', 'Health people', 'Symptomatic Patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20142', 'city': 'Milan', 'state': 'IT', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Stefano Centanni, Full Professor', 'role': 'CONTACT', 'email': 'stefano.centanni@unimi.it', 'phone': '0281843025'}], 'facility': 'AO San Paolo', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}], 'centralContacts': [{'name': 'Stefano Centanni, Full Professor', 'role': 'CONTACT', 'email': 'stefano.centanni@unimi.it', 'phone': '0281843025'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Azienda Ospedaliera San Paolo', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Full Professor', 'investigatorFullName': 'Stefano Centanni', 'investigatorAffiliation': 'Azienda Ospedaliera San Paolo'}}}}