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NCT04490837 Clinical Trial

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

Covid-19 Clinical Trial

— YCOVID  

Official title:
Rapid Diagnostic Test for COVID-19 Based on Antibody Detection

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04490837
Other study ID # 2020/587
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 22, 2020
Est. completion date September 30, 2020

Study information
Verified date July 2021
Source Corporacion Parc Tauli
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 3500
Est. completion date September 30, 2020
Est. primary completion date July 31, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• 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

Locations
Country Name City State
Spain Parc Tauli University Hospital Sabadell Barcelona

Sponsors (1)
Lead Sponsor Collaborator
Corporacion Parc Tauli

Country where clinical trial is conducted

Spain, 

Outcome
Type Measure Description Time frame Safety issue
Primary IgG anti-COVID-19 IgG antibodies against COVID-19 RBD From May to July
Primary IgM anti-COVID-19 IgM antibodies against COVID-19 RBD From May to July
Primary IgA anti-COVID-19 IgA antibodies against COVID-19 RBD From May to July
Secondary Time of onset symptoms From May to July
Secondary COVID-19 PCR results Qualitative result to clasify patients into PCR COVID-19 positive patients and PCR COVID-19 negative patients From May to July
Secondary Radiological studies The presence or abcense of the typical image of the pneumonia caused by COVID-19 From May to July
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