Rapid Diagnostic Test for COVID-19 Based on Antibody Detection (YCOVID)
YCOVID
1 other identifier
observational
3,500
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2020
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 15, 2020
CompletedStudy Start
First participant enrolled
June 22, 2020
CompletedFirst Posted
Study publicly available on registry
July 29, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2020
CompletedJuly 29, 2021
July 1, 2021
1 month
May 15, 2020
July 28, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
IgG anti-COVID-19
IgG antibodies against COVID-19 RBD
From May to July
IgM anti-COVID-19
IgM antibodies against COVID-19 RBD
From May to July
IgA anti-COVID-19
IgA antibodies against COVID-19 RBD
From May to July
Secondary Outcomes (3)
Time of onset symptoms
From May to July
COVID-19 PCR results
From May to July
Radiological studies
From May to July
Study Arms (3)
COVID-19 positive
Patients with clinical, radiological and/or PCR positive for COVID-19 infection
Normal
Normal human serum from blood donnors before COVID-19 pandemia
Pathological controls
Patients with other positive virological serologies
Interventions
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
Eligibility Criteria
Patients with COVID-19 infection Professionals of an University Hospital
You may qualify if:
- Professional from Parc Taulí University Hospital
- Patients with clinical, radiological and/or PCR COVID-19 positive
You may not qualify if:
- Patients or professionals who do not sign informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Parc Tauli University Hospital
Sabadell, Barcelona, 08208, Spain
Biospecimen
Plasma or serum
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Target Duration
- 2 Years
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Senior Medical Doctor
Study Record Dates
First Submitted
May 15, 2020
First Posted
July 29, 2020
Study Start
June 22, 2020
Primary Completion
July 31, 2020
Study Completion
September 30, 2020
Last Updated
July 29, 2021
Record last verified: 2021-07