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

• Sponsor: Corporacion Parc Tauli (Other)
• Overall Status: Completed
• CT.gov ID: NCT04490837
• Collaborator: (none)
• Enrollment: 3,500
• Location: 1
• Actual Duration (Months): 3.3
• Patients Per Site Per Month: 1065.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Covid-19	Diagnostic Test: ELISA and Rapid test to detect antibodies against COVID-19

Study Design

• Study Type: Observational [Patient Registry]
• Actual Enrollment: 3500 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Official Title: Rapid Diagnostic Test for COVID-19 Based on Antibody Detection
• Actual Study Start Date: Jun 22, 2020
• Actual Primary Completion Date: Jul 31, 2020
• Actual Study Completion Date: Sep 30, 2020

Arms and Interventions

Arm	Intervention/Treatment
COVID-19 positive Patients with clinical, radiological and/or PCR positive for COVID-19 infection	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
Normal Normal human serum from blood donnors before COVID-19 pandemia	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
Pathological controls Patients with other positive virological serologies	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

Outcome Measures

Primary Outcome Measures

1. IgG anti-COVID-19 [From May to July]

   IgG antibodies against COVID-19 RBD

2. IgM anti-COVID-19 [From May to July]

   IgM antibodies against COVID-19 RBD

3. IgA anti-COVID-19 [From May to July]

   IgA antibodies against COVID-19 RBD

Secondary Outcome Measures

1. Time of onset symptoms [From May to July]

2. 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

3. Radiological studies [From May to July]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Parc Tauli University Hospital	Sabadell	Barcelona	Spain	08208

Sponsors and Collaborators

• Corporacion Parc Tauli

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Juan Francisco Delgado de la Poza, Senior Medical Doctor, Corporacion Parc Tauli
• ClinicalTrials.gov Identifier: NCT04490837
• Other Study ID Numbers: 2020/587
• First Posted: Jul 29, 2020
• Last Update Posted: Jul 29, 2021
• Last Verified: Jul 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Juan Francisco Delgado de la Poza, Senior Medical Doctor, Corporacion Parc Tauli: Antibodies; Covid-19; Rapid test; RBD
• Additional relevant MeSH terms: COVID-19; Antibodies

Study Results

No Results Posted as of Jul 29, 2021