NCT04490837

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 15, 2020

Completed
1 month until next milestone

Study Start

First participant enrolled

June 22, 2020

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 29, 2020

Completed
2 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2020

Completed
Last Updated

July 29, 2021

Status Verified

July 1, 2021

Enrollment Period

1 month

First QC Date

May 15, 2020

Last Update Submit

July 28, 2021

Conditions

Keywords

AntibodiesCovid-19Rapid testRBD

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

Diagnostic Test: ELISA and Rapid test to detect antibodies against COVID-19

Normal

Normal human serum from blood donnors before COVID-19 pandemia

Diagnostic Test: ELISA and Rapid test to detect antibodies against COVID-19

Pathological controls

Patients with other positive virological serologies

Diagnostic Test: ELISA and Rapid test to detect antibodies against COVID-19

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

COVID-19 positiveNormalPathological controls

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma or serum

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

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

Locations