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SARS-CoV-2 InfectionUB-GTMS-COVIDNCT04784403

SCREENING AND SEROEPIDEMIOLOGY OF SARS-CoV-2 INFECTION AT THE UNIVERSITY OF BARCELONA: A CROSS-SECTIONAL STUDY

An observational study of SARS-CoV-2 Infection, run by Dr. Francisco Ciruela Alférez at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

BACKGROUND: On January 7, 2020, the Chinese authorities identified as the agent responsible for the cases of atypical pneumonia of unknown etiology a new type of virus of the Coronaviridae family that has subsequently been named SARS-CoV-2, whose genetic sequence was shared by Chinese authorities on January 12… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
SARS-CoV-2 Infection
What is being tested?
SARS-CoV-2 PCR and serology tests
How many people
3,356 participants
Where
1 siteSpain
Study dates
14 Dec 2020to 24 Feb 2021
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
  • Adult, Older adult

Study population: The target population of this study is made up of students and workers at the University of Barcelona: * Students from the different centers and type of studies (undergraduate / graduate). * Administrative and service personnel. * Teaching and Research Staff.

Who may be able to join

  • Adult population (18 years or more), of both sexes.
  • Person linked (with identification card) to the University of Barcelona.
  • Acceptance to participate in the study.

Who cannot join

  • There are no exclusion criteria.

Trial locations and contacts

1 site in 1 country.

Spain1 site
  • Francisco Ciruela Alférez

    L'Hospitalet de Llobregat, Barcelona, 08907

Other trials in Spain

About this study

BACKGROUND: On January 7, 2020, the Chinese authorities identified as the agent responsible for the cases of atypical pneumonia of unknown etiology a new type of virus of the Coronaviridae family that has subsequently been named SARS-CoV-2, whose genetic sequence was shared by Chinese authorities on January 12 (taxonomy ID: 2697049). On January 30, 2020, the director general of the World Health Organization (WHO), following the advice of the Emergency Committee convened in accordance with the International Health Regulations (2005), declared that the COVID-19 outbreak started in Wuhan, China in December 2019, being a public health emergency of international concern. On March 11, the WHO declared the global SARS-CoV-2 pandemic.

So far, in the absence of effective vaccines or antiviral drugs, efforts have focused on identifying cases and their contacts. Both the cases and their contacts are isolated for about 14 days with the intention of minimizing the spread of this infection and avoiding an increase in the number of affected.

Read more

At the time of writing this new version of the protocol, we are immersed in the second wave of the COVID-19 pandemic. The projections of the natural history of the disease and the estimates of possible infections by SARS-CoV-2, carried out at the end of the first wave, made it possible to determine the feasibility of this second wave with the onset of cold from the autumn.

Given this scenario, the University of Barcelona, together with the Gerencia Territorial del Área Metropolitana Sud, has planned to carry out, a study of seroprevalence and screnning of SARS-CoV-2 in the population of Universidad de Barcelona users.

The results of this study will help to make preventive decisions in the face of SARS-CoV-2 infection at the UB, in relation to its teaching and administrative activities. In addition, this cross-sectional study can serve as the base study for a future follow-up study.

HYPOTHESIS: The incidence of SARS-CoV-2 infection in the group of students and workers at the University of Barcelona is similar to the incidence in the general population.

MAIN OBJECTIVE:

  • Estimate the incidence of SARS-CoV-2 infection in the UB community.
  • Estimate the SARS-CoV-2 seroprevalence infection in the UB community.
Read the detailed description

BACKGROUND: On January 7, 2020, the Chinese authorities identified as the agent responsible for the cases of atypical pneumonia of unknown etiology a new type of virus of the Coronaviridae family that has subsequently been named SARS-CoV-2, whose genetic sequence was shared by Chinese authorities on January 12 (taxonomy ID: 2697049).

On January 30, 2020, the director general of the World Health Organization (WHO), following the advice of the Emergency Committee convened in accordance with the International Health Regulations (2005), declared that the COVID-19 outbreak started in Wuhan, China in December 2019, being a public health emergency of international concern. On March 11, the WHO declared the global SARS-CoV-2 pandemic.

So far, in the absence of effective vaccines or antiviral drugs, efforts have focused on identifying cases and their contacts. Both the cases and their contacts are isolated for about 14 days with the intention of minimizing the spread of this infection and avoiding an increase in the number of affected.

At the level of microbiological clinical practice, the diagnosis of SARS-CoV-2 infection can be made by:

  1. Detection of the presence of the target nucleic acid sequences in the RNA of SARS-CoV-2 (RdRP gene of SARSCoV-2 and gene N and Orf1ab present in SARS and SARSCoV-2, gene E of SARS) in the Patient specimen by reverse transcriptase polymerase chain reaction (RT-PCR).
  2. Detection of antibodies: total immunoglobulins and IgG.

At the time of writing this new version of the protocol, the country is immersed in the second wave of the COVID-19 pandemic. The projections of the natural history of the disease and the estimates of possible infections by SARS-CoV-2, carried out at the end of the first wave, made it possible to determine the feasibility of this second wave with the onset of cold from the autumn. Some of the factors that supported this hypothesis are:

  1. At the end of the first wave, herd immunity against the virus was not reached. The results of the ENE-COVID study, published in the Lancet magazine in July this year, indicated that in our environment only 6% have achieved immunity.
  2. Many respiratory viruses have a seasonal behavior and their circulation increases in the autumn and winter months. This is why a similar behavior was assumed in this new SARS-CoV-2 virus, experiencing greater transmissibility with the drop in temperature and increase in humidity, typical of winter periods.
  3. Observing the evolution of the 1918 pandemic flu, the first wave was in 1918, but this was followed by a second and third wave, in 1919 and 1920 respectively. However, the second wave presented the peculiarity of being triggered in other areas where the first wave had not been so intense.

Given this scenario, the University of Barcelona, together with the Gerencia Territorial del Área Metropolitana Sud, has planned to carry out, a study of seroprevalence and screnning of SARS-CoV-2 in the population of UB users. The results of this study will help to make preventive decisions in the face of SARS-CoV-2 infection at the UB, in relation to its teaching and administrative activities. In addition, this cross-sectional study can serve as the base study for a future follow-up study.

HYPOTHESIS: The incidence of SARS-CoV-2 infection in the group of students and workers at the University of Barcelona is similar to the incidence in the general population.

The seroprevalence of SARS-CoV-2 infection in the group of students and workers at the University of Barcelona is similar to the seroprevalence of the general population.

MAIN OBJECTIVE

  • Estimate the incidence of SARS-CoV-2 infection in the UB community.
  • Estimate the SARS-CoV-2 seroprevalence infection in the UB community.

SECONDARY OBJECTIVES

Clinical objectives:

  • Estimate the factors associated with the incidence in the UB community.
  • Estimate the factors associated with seroprevalence in the UB community

STUDY DESIGN Cross-sectional study with epidemiological information to determine the incidence and prevalence of SARS-CoV-2 infection in the UB population, by PCR and serology tests to detect antibodies.

Being tested
SARS-CoV-2 PCR and serology tests
Keywords
SARS-COV-2, prevalence, Associated factors, University of Barcelona
Medical subject headings
COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SARS-CoV-2 PCR and serology testsDiagnostic test

    Also called epidemiological survey

    Once the informed consent has been signed, the selected subjects must complete an epidemiological survey and go to a UB sample collection center to perform a PCR and serology test for SARS-CoV-2.

Study groups in NCT04784403
Study groupRoleWhat they receive
Students and workers at the University of BarcelonaThe study population will be randomly selected from the different groups of the University: * Students from the different centers and type of studies (undergraduate / graduate). * Administrative and service personnel. * Teaching and Research Staff.
Receives: Diagnostic Test: SARS-CoV-2 PCR and serology tests

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of people with a positive SARS-CoV-2 PCR.

    Measured: one day

  2. Incidence of people with a positive SARS-CoV-2 PCR.

    Measured: one day

  3. Number of people with a positive total immunoglobulin titer and positive IgG for SARS-CoV-2.

    Measured: one day

  4. Prevalence of people with a positive total immunoglobulin titer and positive IgG for SARS-CoV-2.

    Measured: one day

Secondary outcomes (1)
  1. Number of people with a positive SARS-CoV-2 Ig total titer and a negative IgG.

    Measured: one day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Mar 2021
  2. Study start14 Dec 2020
  3. Primary completion24 Feb 2021
  4. Study completion24 Feb 2021

Resources

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
Ecologic or community
Time perspective
Prospective
Enrolment
3,356 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04784403
Sponsor's protocol ID
UB-EPI-2020-01
Acronym
UB-GTMS-COVID
Status last verified
Mar 2021
First submitted
21 Dec 2020
Last updated
5 Mar 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Pollan M, Perez-Gomez B, Pastor-Barriuso R, Oteo J, Hernan MA, Perez-Olmeda M, Sanmartin JL, Fernandez-Garcia A, Cruz I, Fernandez de Larrea N, Molina M, Rodriguez-Cabrera F, Martin M, Merino-Amador P, Leon Paniagua J, Munoz-Montalvo JF, Blanco F, Yotti R; ENE-COVID Study Group. Prevalence of SARS-CoV-2 in Spain (ENE-COVID): a nationwide, population-based seroepidemiological study. Lancet. 2020 Aug 22;396(10250):535-544. doi: 10.1016/S0140-6736(20)31483-5. Epub 2020 Jul 6.

    PubMed 32645347
  • 5. Albert Bosch. SARS-CoV-2: ¿No solo un virus? Ciclo de webinars. Patógenos Online. Grupo Especializado en Biología de Microrganismos Patógenos (GEBMP). Sociedad Española de Microbiología, 30 de junio de 2020.

Questions about this trial

What is this clinical trial studying?

An observational study of SARS-CoV-2 Infection, run by Dr. Francisco Ciruela Alférez 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 3 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 5 Mar 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?

Number of people with a positive SARS-CoV-2 PCR. (time frame: one day). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04784403, which also lists 2 linked publications.

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 5 Mar 2021.

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