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OpenTrials
Completed

NCT Number: NCT04490837

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

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.

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Key information

Conditions

COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Parc Tauli University Hospital

Sabadell, Barcelona, 08208, Spain

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ELISA and Rapid test to detect antibodies against COVID-19

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

Primary outcomes

  1. IgG anti-COVID-19

    Time frame: From May to July

    IgG antibodies against COVID-19 RBD

  2. IgM anti-COVID-19

    Time frame: From May to July

    IgM antibodies against COVID-19 RBD

  3. IgA anti-COVID-19

    Time frame: From May to July

    IgA antibodies against COVID-19 RBD

Secondary outcomes

  1. Time of onset symptoms

    Time frame: From May to July

  2. COVID-19 PCR results

    Time frame: From May to July

    Qualitative result to clasify patients into PCR COVID-19 positive patients and PCR COVID-19 negative patients

  3. Radiological studies

    Time frame: From May to July

    The presence or abcense of the typical image of the pneumonia caused by COVID-19

Sponsors and collaborators

Lead sponsor

Corporacion Parc Tauli

Other

Registry information

Official study title

Rapid Diagnostic Test for COVID-19 Based on Antibody Detection

Acronym: YCOVID

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jul 29, 2020
Registry last updated
Jul 29, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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