Covid-19YCOVIDNCT04490837
Rapid Diagnostic Test for COVID-19 Based on Antibody Detection (YCOVID)
An observational study of Covid-19, run by Corporacion Parc Tauli at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Covid-19
- What is being tested?
- ELISA and Rapid test to detect antibodies against COVID-19
- How many people
- 3,500 participants
- Where
- 1 siteSpain
- Study dates
- 22 Jun 2020to 30 Sep 2020
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with COVID-19 infection Professionals of an University Hospital
Who may be able to join
- Professional from Parc Taulí University Hospital
- Patients with clinical, radiological and/or PCR COVID-19 positive
Who cannot join
- Patients or professionals who do not sign informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Rapid Diagnostic Test for COVID-19 Based on Antibody Detection
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.
- Conditions
- Covid-19
- Being tested
- ELISA and Rapid test to detect antibodies against COVID-19
- Keywords
- Antibodies, Covid-19, Rapid test, RBD
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ELISA and Rapid test to detect antibodies against COVID-19Diagnostic 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
| Study group | Role | What they receive |
|---|---|---|
| COVID-19 positive | Patients with clinical, radiological and/or PCR positive for COVID-19 infection Receives: Diagnostic Test: ELISA and Rapid test to detect antibodies against COVID-19 | |
| Normal | Normal human serum from blood donnors before COVID-19 pandemia Receives: Diagnostic Test: ELISA and Rapid test to detect antibodies against COVID-19 | |
| Pathological controls | Patients with other positive virological serologies Receives: Diagnostic Test: ELISA and Rapid test to detect antibodies against COVID-19 |
What is being measured
The primary outcome is the main question the study is designed to answer.
IgG anti-COVID-19
IgG antibodies against COVID-19 RBD
Measured: From May to July
IgM anti-COVID-19
IgM antibodies against COVID-19 RBD
Measured: From May to July
IgA anti-COVID-19
IgA antibodies against COVID-19 RBD
Measured: From May to July
Secondary outcomes (3)
Time of onset symptoms
Measured: From May to July
COVID-19 PCR results
Qualitative result to clasify patients into PCR COVID-19 positive patients and PCR COVID-19 negative patients
Measured: From May to July
Radiological studies
The presence or abcense of the typical image of the pneumonia caused by COVID-19
Measured: From May to July
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2020
- Study start22 Jun 2020
- Primary completion31 Jul 2020
- Study completion30 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 3,500 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Corporacion Parc Tauli
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Juan Francisco Delgado de la Poza, Corporacion Parc Tauli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04490837
- Sponsor's protocol ID
- 2020/587
- Acronym
- YCOVID
- Status last verified
- Jul 2021
- First submitted
- 15 May 2020
- Last updated
- 29 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rapid Diagnostic Test for COVID-19 Based on Antibody Detection
- ClinicalTrials.gov ID
- NCT04490837
- Acronym / sponsor ID
- YCOVID / 2020/587
- Conditions
- Covid-19
- Keywords
- Antibodies, Covid-19, Rapid test, RBD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,500 participants (actual)
- Lead sponsor
- Corporacion Parc TauliUniversity, hospital or other
- Study start
- 22 Jun 2020 (actual)
- Primary completion
- 31 Jul 2020 (actual)
- Study completion
- 30 Sep 2020 (actual)
- First posted
- 29 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| COVID-19 positive | – | Diagnostic Test: ELISA and Rapid test to detect antibodies against COVID-19Patients with clinical, radiological and/or PCR positive for COVID-19 infection |
| Normal | – | Diagnostic Test: ELISA and Rapid test to detect antibodies against COVID-19Normal human serum from blood donnors before COVID-19 pandemia |
| Pathological controls | – | Diagnostic Test: ELISA and Rapid test to detect antibodies against COVID-19Patients with other positive virological serologies |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with COVID-19 infection Professionals of an University Hospital
Key inclusion criteria (2 listed)
- Professional from Parc Taulí University Hospital
- Patients with clinical, radiological and/or PCR COVID-19 positive
Key exclusion criteria (1 listed)
- Patients or professionals who do not sign informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ELISA and Rapid test to detect antibodies against COVID-19Ycovid-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 | Diagnostic test | COVID-19 positive, Normal, Pathological controls |
Primary outcome
IgG anti-COVID-19
Time frame: From May to July
IgG antibodies against COVID-19 RBD
IgM anti-COVID-19
Time frame: From May to July
IgM antibodies against COVID-19 RBD
IgA anti-COVID-19
Time frame: From May to July
IgA antibodies against COVID-19 RBD
3 secondary outcomes
Time of onset symptoms
Time frame: From May to July
COVID-19 PCR results
Time frame: From May to July
Radiological studies
Time frame: From May to July
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid-19, run by Corporacion Parc Tauli at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
IgG anti-COVID-19 (time frame: From May to July). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2021.