Seroprevalence of IgG Antibodies to SARS-CoV-2 (COVID-19) in Primary Health Care Workers and Their Household Contacts

• Register: ClinicalTrials.gov
• Last refreshed on: 29 March 2021
• Main ID: NCT04808986
• Date of registration: 17/03/2021
• Prospective Registration: Yes
• Primary sponsor: Institut National de la Santé Et de la Recherche Médicale, France
• Public title: Seroprevalence of IgG Antibodies to SARS-CoV-2 (COVID-19) in Primary Health Care Workers and Their Household Contacts COVID-SeroPRIM
• Scientific title: Séroprévalence Des IgG dirigés Contre le SARS-CoV-2 Chez Les Professionnels de santé en Soins Primaires et Leurs Contacts au Sein Des ménages
• Date of first enrolment: April 2, 2021
• Target sample size: 2000
• Recruitment status: Not yet recruiting
• URL: https://clinicaltrials.gov/show/NCT04808986
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Other. Masking: None (Open Label).
• Phase: N/A

Key inclusion & exclusion criteria

Inclusion Criteria:

Health professionals in primary care :

- General practitioners, paediatricians, pharmacists, pharmacy assistants, dental
surgeons or dental assistants practising in metropolitan France at the time of
inclusion (condition ensured by affiliation to one of the four networks);

- Be affiliated to one of the following networks: Sentinelles, AFPA, IQVIA, ReCOL or
work in a city pharmacy (for pharmacy assistants) or in a dental practice (dental
assistants) whose owners are affiliated to these networks;

- To be a volunteer to participate in the study;

- To have given their agreement in principle to the collection of data (including
personal data) necessary for recruitment;

- Have given their consent to participate in the study;

- To be affiliated to a social security scheme or to be a beneficiary of such a scheme.

Members of health professionals' households :

- Occupy the same dwelling as a healthcare professional included in PHASE 1 of the
COVID-SeroPRIM study at least 2 days per week (including weekend attendees, every
other week, etc.) at the time of inclusion in the study, without necessarily being
related;

- To have volunteered to participate in the study;

- To have given their consent to participate in the study or, in the case of minors,
consent given by the representative(s) of the parental authority;

- To be able to understand the study process, to fill in the questionnaires and to take
the planned samples (if the person included is old enough to understand).

Exclusion criteria :

- Persons subject to a legal protection measure (safeguard of justice, curatorship,
guardianship);

- Persons who have participated in clinical trials to test chemoprophylaxis to prevent
infection with SARS-CoV-2.

- Minors who do not have a parent or guardian in the health professional's household



Age minimum: N/A
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Covid19

Intervention(s)

Diagnostic Test: Serological test for the detection of IgG anti-SARS-CoV-2

Primary Outcome(s)

Seroprevalence estimates in health care professionals [Time Frame: 3 months]

Secondary ID(s)

C20-72

ID RCB : 2020-A03298-31

Source(s) of Monetary Support

Please refer to primary and secondary sponsors