Rapid Diagnostic Test for COVID-19 Based on Antibody Detection (YCOVID)

NCT ID: NCT04490837

Last Updated: 2021-07-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

3500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-06-22

Study Completion Date

2020-09-30

Brief Summary

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Ycovid-19 aims to be a rapid diagnostic test for SARS-CoV-2 infection, which will allow a reliable diagnosis to be made in 10 minutes, and on easy-to-use devices. This test will be developed using innovative technology developed at the Parc Taulí University Hospital, which increases the immunogenicity of SARS-CoV-2 differential antigens. The increased immunogenicity of these antigens will allow to detect, with a high sensitivity and specificity, the antibodies in the serum of patients infected with SARS-CoV-2. This test will serve to confirm dubious results as well as reduce false negatives from the PCR test, which will ultimately help reduce transmission of the infection.

Detailed Description

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Conditions

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Covid-19

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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COVID-19 positive

Patients with clinical, radiological and/or PCR positive for COVID-19 infection

ELISA and Rapid test to detect antibodies against COVID-19

Intervention Type DIAGNOSTIC_TEST

Ycovid-19 aims to be a rapid diagnostic test for SARS-CoV-2 infection, which will allow a reliable diagnosis to be made in 10 minutes, and on easy-to-use devices

Normal

Normal human serum from blood donnors before COVID-19 pandemia

ELISA and Rapid test to detect antibodies against COVID-19

Intervention Type DIAGNOSTIC_TEST

Ycovid-19 aims to be a rapid diagnostic test for SARS-CoV-2 infection, which will allow a reliable diagnosis to be made in 10 minutes, and on easy-to-use devices

Pathological controls

Patients with other positive virological serologies

ELISA and Rapid test to detect antibodies against COVID-19

Intervention Type DIAGNOSTIC_TEST

Ycovid-19 aims to be a rapid diagnostic test for SARS-CoV-2 infection, which will allow a reliable diagnosis to be made in 10 minutes, and on easy-to-use devices

Interventions

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ELISA and Rapid test to detect antibodies against COVID-19

Ycovid-19 aims to be a rapid diagnostic test for SARS-CoV-2 infection, which will allow a reliable diagnosis to be made in 10 minutes, and on easy-to-use devices

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Professional from Parc Taulí University Hospital
* Patients with clinical, radiological and/or PCR COVID-19 positive

Exclusion Criteria

* Patients or professionals who do not sign informed consent
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Corporacion Parc Tauli

OTHER

Sponsor Role lead

Responsible Party

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Juan Francisco Delgado de la Poza

Senior Medical Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Parc Tauli University Hospital

Sabadell, Barcelona, Spain

Site Status

Countries

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Spain

Other Identifiers

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2020/587

Identifier Type: -

Identifier Source: org_study_id

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