Clinical trial NCT04425759: Prevalence and Risk Factors of SARS-CoV-2 Antibody Responses (COVID-19)
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)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Covid19
Corona Virus Infection
SARS-CoV 2
COVID
Keywords: COVID
ANTIBODY
SARS-COV2
Lead sponsor: Hospital de Mataró
Sponsor class: OTHER
First posted: 2020-06-11
Enrollment: 2400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Professionals working at the Maresme Health Consortium (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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* None.

Primary outcomes:
measure: Antibodies to SARS-CoV2: IgA, IgM, IgG
timeFrame: 1 year
measure: PCR of nasopharyngeal smears on all IgM +
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Mataró
country: Spain
facility: Hospital de Mataró
state: Barcelona
Study officials:
affiliation: Hospital de Mataró
name: Pere Clavé, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: