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

NCT04425759 | Unknown

• 1 other identifier: SERO-MARES (56/20)
• Study Type: observational
• Target: 2,400
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

COVID; ANTIBODY; SARS-COV2

Outcome Measures

Primary Outcomes (2)

• 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

Interventions

Blood sample DIAGNOSTIC_TEST

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Professionals working at the Maresme Health Consortium (CSdM).

You may qualify if:

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

You may not qualify if:

• None.

Sponsors & Collaborators

• Hospital de Mataró: lead

Study Sites (1)

Hospital de Mataró

Mataró, Barcelona, 08304, Spain

RECRUITING

MeSH Terms

Conditions

COVID-19; Coronavirus Infections

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Pere Clavé, MD, PhD

  Hospital de Mataró

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pere Clavé, MD, PhD

CONTACT

+34937417700; pere.clave@ciberehd.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Research and Academic Development at CSdM

Study Record Dates

• First Submitted: June 8, 2020
• First Posted: June 11, 2020
• Study Start: June 8, 2020
• Primary Completion: June 30, 2021
• Study Completion: June 30, 2021
• Last Updated: June 16, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)