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

Completed

• Conditions: Covid-19
• Interventions: Diagnostic Test: ELISA and Rapid test to detect antibodies against COVID-19

• Registration Number: NCT04490837
• Lead Sponsor: Corporacion Parc Tauli

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-05-15
• Study Start: 2020-06-22
• Study First Submitted QC: 2020-07-28
• Study First Posted: 2020-07-29
• Primary Completion: 2020-07-31
• Study Completion: 2020-09-30
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-28
• Last Update Posted: 2021-07-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3500

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Normal	ELISA and Rapid test to detect antibodies against COVID-19	Normal human serum from blood donnors before COVID-19 pandemia
COVID-19 positive	ELISA and Rapid test to detect antibodies against COVID-19	Patients with clinical, radiological and/or PCR positive for COVID-19 infection
Pathological controls	ELISA and Rapid test to detect antibodies against COVID-19	Patients with other positive virological serologies

Primary Outcome Measures

Name	Time	Method
IgG anti-COVID-19	From May to July	IgG antibodies against COVID-19 RBD
IgM anti-COVID-19	From May to July	IgM antibodies against COVID-19 RBD
IgA anti-COVID-19	From May to July	IgA antibodies against COVID-19 RBD

Secondary Outcome Measures

Name	Time	Method
Time of onset symptoms	From May to July
COVID-19 PCR results	From May to July	Qualitative result to clasify patients into PCR COVID-19 positive patients and PCR COVID-19 negative patients
Radiological studies	From May to July	The presence or abcense of the typical image of the pneumonia caused by COVID-19

Trial Locations

Locations (1)

Parc Tauli University Hospital; 🇪🇸 Sabadell, Barcelona, Spain