Prevalence and Risk Factors of SARS-CoV-2 Antibody Responses (COVID-19)

NCT ID: NCT04425759

Last Updated: 2020-06-16

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 2400 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-06-08
• Study Completion Date: 2021-06-30

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.

Conditions

Covid19; Corona Virus Infection; SARS-CoV 2; COVID

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Blood sample

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

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• None.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Hospital de Mataró

OTHER

Sponsor Role: lead

Responsible Party

Pere Clave

Director of Research and Academic Development at CSdM

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Pere Clavé, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital de Mataró

Locations

Hospital de Mataró

Mataró, Barcelona, Spain

Site Status: RECRUITING

Countries

Spain

Central Contacts

Pere Clavé, MD, PhD

Role: CONTACT

pere.clave@ciberehd.org

+34937417700 ext. 1046

Facility Contacts

Pere Clavé, MD

Role: primary

pere.clave@ciberehd.org

937417700 ext. 2285

Other Identifiers

SERO-MARES (56/20)

Identifier Type: -

Identifier Source: org_study_id