Covid19SERO-MARESNCT04425759
Prevalence and Risk Factors of SARS-CoV-2 Antibody Responses (COVID-19)
An observational study of Covid19 and Corona Virus Infection, run by Hospital de Mataró at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Covid19, Corona Virus Infection, SARS-CoV 2
- What is being tested?
- Blood sample
- How many people
- 2,400 participants
- Where
- 1 siteSpain
- Study dates
- 8 Jun 2020to 30 Jun 2021
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Professionals working at the Maresme Health Consortium (CSdM).
Who may be able to join
- All the professionals working at the Consorci Sanitari del Maresme (approximately 2300 subjects).
Who cannot join
- None.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital de Mataró
Mataró, Barcelona, 08304
Pere Clavé, MD, 937417700 ext. 2285, pere.clave@ciberehd.org
About this study
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)
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.
Read the 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:
- Let them know if they have been exposed to the SARS-CoV-2 virus.
- Identify asymptomatic carriers of SARS-CoV-2 virus.
- 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:
- Screening the entire population with total CLIA result (IgA, IgM, IgG) to determine negatives.
- ELISA for positives with differentiated IgM, IgA and IgG results.
- 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
- Being tested
- Blood sample
- Keywords
- COVID, ANTIBODY, SARS-COV2
- Medical subject headings
- COVID-19, Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sampleDiagnostic test
Blood sammples for the serological analysis will be collected at 0/90/180/270/360 days.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2020
- Study start8 Jun 2020
- Primary completion30 Jun 2021 (estimated)
- Study completion30 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,400 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Hospital de Mataró
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pere Clave, Hospital de Mataró
- Investigators
- Pere Clavé, MD, PhD, Principal investigator, Hospital de Mataró
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04425759
- Sponsor's protocol ID
- SERO-MARES (56/20)
- Acronym
- SERO-MARES
- Status last verified
- Jun 2020
- First submitted
- 8 Jun 2020
- Last updated
- 16 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Barrufet MP, Serra-Prat M, Palomera E, Ruiz A, Tapias G, Montserrat N, Valladares N, Ruz FJ, Bolivar-Prados M, Clave P. Prevalence and risk factors of SARS-CoV-2 antibody responses among healthcare workers (June 2020-November 2021). Eur J Public Health. 2023 Oct 10;33(5):923-929. doi: 10.1093/eurpub/ckad093.
PubMed 37311716
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT04425759
- Acronym / sponsor ID
- SERO-MARES / SERO-MARES (56/20)
- Conditions
- Covid19, Corona Virus Infection, SARS-CoV 2, COVID
- Keywords
- COVID, ANTIBODY, SARS-COV2
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,400 participants (estimated)
- Lead sponsor
- Hospital de MataróUniversity, hospital or other
- Study start
- 8 Jun 2020 (actual)
- Primary completion
- 30 Jun 2021 (estimated)
- Study completion
- 30 Jun 2021 (estimated)
- First posted
- 11 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Let them know if they have been exposed to the SARS-CoV-2 virus.
- Identify asymptomatic carriers of SARS-CoV-2 virus.
- 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:
- Screening the entire population with total CLIA result (IgA, IgM, IgG) to determine negatives.
- ELISA for positives with differentiated IgM, IgA and IgG results.
- 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Professionals working at the Maresme Health Consortium (CSdM).
Key inclusion criteria (1 listed)
- All the professionals working at the Consorci Sanitari del Maresme (approximately 2300 subjects).
Key exclusion criteria (1 listed)
- None.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood sampleBlood sammples for the serological analysis will be collected at 0/90/180/270/360 days. | Diagnostic test | – |
Primary outcome
Antibodies to SARS-CoV2: IgA, IgM, IgG
Time frame: 1 year
* 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.
PCR of nasopharyngeal smears on all IgM +
Time frame: 1 year
* To detect symptomatic or asymptomatic carriers * New diagnostics of COVID19 confirmed by PCR of nasopharyngeal smears
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2020.
- Derived from this study: PubMed 37311716Barrufet MP, Serra-Prat M, Palomera E, Ruiz A, Tapias G, Montserrat N, Valladares N, Ruz FJ, Bolivar-Prados M, Clave P. Prevalence and risk factors of SARS-CoV-2 antibody responses among healthcare workers (June 2020-November 2021). Eur J Public Health. 2023 Oct 10;33(5):923-929. doi: 10.1093/eurpub/ckad093.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pere Clavé, MD, PhD principal investigator
Hospital de Mataró
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19 and Corona Virus Infection, run by Hospital de Mataró at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pere Clavé, MD, PhD (+34937417700 ext. 1046, pere.clave@ciberehd.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Antibodies to SARS-CoV2: IgA, IgM, IgG (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04425759, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2020.