Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Sensitivity Evaluation of Serological Tests for Covid-19 (COVIDIAGNOSTIX)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04678024
Recruitment Status : Enrolling by invitation
First Posted : December 21, 2020
Last Update Posted : December 24, 2020
Sponsor:
Information provided by (Responsible Party):
Istituto Ortopedico Galeazzi

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief 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.

Condition or disease
Covid19

Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Estimated Enrollment : 410 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Multicentric Sensitivity Assessment of Antibody Diagnostic Tests Developed for Diagnosis of SARS-CoV2 Infection
Actual Study Start Date : November 18, 2020
Estimated Primary Completion Date : August 2021
Estimated Study Completion Date : November 2021

Resource links provided by the National Library of Medicine


Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Sensitivity [ Time Frame: Up to 22 weeks ]
    Sensitivity and Specificity Evaluation in Diagnostic Sierological tests


Secondary Outcome Measures :
  1. Specificity [ Time Frame: Through study completion, an average of 1 year ]
    Sensitivity and Specificity Evaluation in Diagnostic Sierological tests


Other Outcome Measures:
  1. HTA [ Time Frame: Up to 20 weeks ]

Biospecimen Retention:   Samples With DNA
Blood samples

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
All patients or individuals exposed to Sars-Cov2 Infection.
Criteria

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

Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT04678024


Locations
Layout table for location information
Italy
Istituto Ortopedico Galeazzi
Milan, Italy, 20161
Sponsors and Collaborators
Istituto Ortopedico Galeazzi
Investigators
Layout table for investigator information
Principal Investigator: Giuseppe Banfi IRCCS Orthopedic Institute Galeazzi
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Istituto Ortopedico Galeazzi
ClinicalTrials.gov Identifier: NCT04678024    
Other Study ID Numbers: COVIDIAGNOSTIX
First Posted: December 21, 2020    Key Record Dates
Last Update Posted: December 24, 2020
Last Verified: December 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Istituto Ortopedico Galeazzi:
test sierologici
Additional relevant MeSH terms:
Layout table for MeSH terms
COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
 Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases