NCT04784403

Brief 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 (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 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
3,356

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 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

Study Start

First participant enrolled

December 14, 2020

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

December 21, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 24, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 24, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 5, 2021

Completed
Last Updated

March 5, 2021

Status Verified

March 1, 2021

Enrollment Period

2 months

First QC Date

December 21, 2020

Last Update Submit

March 3, 2021

Conditions

SARS-CoV-2 Infection

Keywords

SARS-COV-2prevalenceAssociated factorsUniversity of Barcelona

Outcome Measures

Primary Outcomes (4)

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

    one day

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

    one day

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

    one day

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

    one day

Secondary Outcomes (1)

  • Number of people with a positive SARS-CoV-2 Ig total titer and a negative IgG.

    one day

Other Outcomes (1)

  • Estimation of associated factors ith the main variable (age, sex, university group and variables of exposure and preventive measures)

    one day

Study Arms (1)

Students and workers at the University of Barcelona

The 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.

Diagnostic Test: SARS-CoV-2 PCR and serology tests

Interventions

SARS-CoV-2 PCR and serology testsDIAGNOSTIC_TEST

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.

Also known as: epidemiological survey
Students and workers at the University of Barcelona

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
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.

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Francisco Ciruela Alférez

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

Location

Related Publications (2)

  • 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.

    PMID: 32645347BACKGROUND

  • 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.

    BACKGROUND

Related Links

MeSH Terms

Conditions

COVID-19

Interventions

Serologic Tests

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Immunologic TestsClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative TechniquesImmunologic Techniques

Study Officials

  • Sebastià Videla Cés, MD PhD

    Hospital Universitario de Bellvitge

    STUDY DIRECTOR

  • Esteve Fernández Muñoz, Professor

    Universidad de Barcelona

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Sponsor's representative

Study Record Dates

First Submitted

December 21, 2020

First Posted

March 5, 2021

Study Start

December 14, 2020

Primary Completion

February 24, 2021

Study Completion

February 24, 2021

Last Updated

March 5, 2021

Record last verified: 2021-03

Locations

ES(1)