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NCT04678024 Clinical Trial

Sensitivity Evaluation of Serological Tests for Covid-19

Covid19 Clinical Trial

— COVIDIAGNOSTIX  

Official title:
Multicentric Sensitivity Assessment of Antibody Diagnostic Tests Developed for Diagnosis of SARS-CoV2 Infection

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT04678024
Other study ID # COVIDIAGNOSTIX
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
Start date November 18, 2020
Est. completion date November 2021

Study information
Verified date December 2020
Source Istituto Ortopedico Galeazzi
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The primary objective of this study is to test the diagnostic sensitivity of antibody tests for the diagnosis of SARS-CoV2 infection, available to clinical laboratories, within a national network of hospitals carrying out research activities. Test the diagnostic specificity of antibody tests for the diagnosis of SARS-CoV2 infection. Complete a systematic evaluation of the different approaches. Perform Health technology Assessment (HITA) of the methodologies under study, in order to verify their reliability to the immunoglobulin levels produced by each individual exposed patient.

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 410
Est. completion date November 2021
Est. primary completion date August 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: All patients or individuals exposed to Sars-Cov2 Infection. Exclusion Criteria: There are no criteria for excluding patients or individuals, if not the refusal to participate to project

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Italy Istituto Ortopedico Galeazzi Milan

Sponsors (1)
Lead Sponsor Collaborator
Istituto Ortopedico Galeazzi

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Other HTA Up to 20 weeks
Primary Sensitivity Sensitivity and Specificity Evaluation in Diagnostic Sierological tests Up to 22 weeks
Secondary Specificity Sensitivity and Specificity Evaluation in Diagnostic Sierological tests Through study completion, an average of 1 year
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