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

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)

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.

Study Overview

• Status: Unknown
• Conditions: SARS-CoV 2; Covid19; COVID; Corona Virus Infection
• Intervention / Treatment: Diagnostic test: Blood sample

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.

• Study Type: Observational
• Enrollment (Anticipated): 2400

Contacts and Locations

Study Locations

• Spain
  • Barcelona
    • Mataró, Barcelona, Spain, 08304
      • Recruiting
      • Hospital de Mataró
      • Contact: Pere Clavé, MD; Phone Number: 2285 937417700; Email: pere.clave@ciberehd.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Professionals working at the Maresme Health Consortium (CSdM).

Description

Inclusion Criteria:

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

Exclusion Criteria:

• None.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Antibodies to SARS-CoV2: IgA, IgM, IgG	Screening for the entire population with total IgA, IgM, IgG to screen the negatives; ELISA for positives with differentiated IgM+IgA vs IgG specific for SARS-Cov-2 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.	1 year
PCR of nasopharyngeal smears on all IgM +	To detect symptomatic or asymptomatic carriers; New diagnostics of COVID19 confirmed by PCR of nasopharyngeal smears	1 year

Collaborators and Investigators

• Sponsor: Hospital de Mataró
• Investigators: Principal Investigator: Pere Clavé, MD, PhD, Hospital de Mataró

Study record dates

Study Major Dates

• Study Start (Actual): June 8, 2020
• Primary Completion (Anticipated): June 30, 2021
• Study Completion (Anticipated): June 30, 2021

Study Registration Dates

• First Submitted: June 8, 2020
• First Submitted That Met QC Criteria: June 8, 2020
• First Posted (Actual): June 11, 2020

Study Record Updates

• Last Update Posted (Actual): June 16, 2020
• Last Update Submitted That Met QC Criteria: June 12, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: COVID; SARS-COV2; ANTIBODY
• Additional Relevant MeSH Terms: Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Coronavirus Infections
• Other Study ID Numbers: SERO-MARES (56/20)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No