Official Title
Prevalence and Risk Factors of SARS-CoV-2 Antibody Responses and Assymptomatic Carriers Among a Cohort of 2,300 Healthcare Workers at the Consorci Sanitari Del Maresme (CSdM)
Brief Summary

Observational and prospective study with one year of follow-up of the cohort of workers of the CSdM, including workers of subcontracted companies working in the Hospital of Mataró (2,300 workers approximately) and with controls at baseline and at 3, 6, 9 and 12 months. All CSdM workers will be invited to participate by e-mail and by announcements in the corporate website. A space will be set up on the corporate intranet where workers will be informed about the study, will be able to give their informed consent and will be able to answer an electronic questionnaire regarding socio-demographic, clinical and labour personal characteristics. Once the questionnaire answered, participants will be authorized to schedule a blood extraction. Prevalence of antibodies against SARS-CoV-2 will be analyzed (IgA, IgM, IgG). PCR will be also performed for IgM and IgA positive subjects.

Detailed Description

- Study design: observational and prospective study with one year of follow-up of the
cohort of workers of the CSdM, including workers of subcontracted companies working in
the Hospital of Mataró (2,300 workers approximately) and with controls at baseline and
at 3, 6, 9 and 12 months.

- Aims: to perform a universal test for all the professionals of the Consorci Sanitari del
Maresme (CSdM) in order to carry out the following objectives:

1. Let them know if they have been exposed to the SARS-CoV-2 virus.

2. Identify asymptomatic carriers of SARS-CoV-2 virus.

3. Develop an immune map of all the professionals to: a) describe the seroprevalence
of SARS-CoV-2 antibodies and their evolution over a year; b) help minimize the risk
of infection in CSdM professionals; c) contribute to the improvement of knowledge
about the infection and the social and occupational factors that affect its spread;
and d) allow in the future to identify the duration of immunity against SARS-CoV-2.

- Time Frame: 1 year.

- Study population: all workers from the healthcare centers of the Consorci Sanitari del
Maresme will be invited to participate by e-mail and by announcements in the corporate
website. A space will be set up on the corporate intranet where workers will be informed
about the study, will be able to give their informed consent and will be able to answer
an electronic questionnaire regarding socio-demographic, clinical and labour personal
characteristics. Once the questionnaire answered, participants will be authorized to
schedule a blood extraction.

- Methods: Prevalence of antibodies against SARS-CoV-2 will be analyzed (IgA, IgM, IgG)
and PCR will be also performed for IgM and IgA positive subjects following this
algorithm:

Serological study:

1. Screening the entire population with total CLIA result (IgA, IgM, IgG) to determine
negatives.

2. ELISA for positives with differentiated IgM, IgA and IgG results.

3. PCR of nasopharyngeal smears on all IgM and IgA + (to determine asymptomatic cases).

There will be other blood samplings and determination points at 3, 6, 9 and 12 months for all
the study participants.

Unknown status
COVID19
Corona Virus Infection
SARS-CoV 2
COVID

Diagnostic Test: Blood sample

Blood sammples for the serological analysis will be collected at 0/90/180/270/360 days.

Eligibility Criteria

Inclusion Criteria:

- All the professionals working at the Consorci Sanitari del Maresme (approximately 2300
subjects).

Exclusion Criteria:

- None.

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
Spain
Locations

Hospital de Mataró
Mataró, Barcelona, Spain

Investigator: Pere Clavé, MD
Contact: 937417700
pere.clave@ciberehd.org

Contacts

Pere Clavé, MD, PhD
+34937417700 - 1046
pere.clave@ciberehd.org

Pere Clavé, MD, PhD, Principal Investigator
Hospital de Mataró

Hospital de Mataró
NCT Number
Keywords
Covid
antibody
SARS-CoV2
MeSH Terms
COVID-19
Coronavirus Infections