Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04808986 |
| Other study ID # |
C20-72 |
| Secondary ID |
ID RCB : 2020-A0 |
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
May 10, 2021 |
| Est. completion date |
October 12, 2021 |
Study information
| Verified date |
November 2023 |
| Source |
Institut National de la Santé Et de la Recherche Médicale, France |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Many uncertainties remain regarding the epidemiological and clinical characteristics of
COVID-19, including the number of people exposed to the disease, the persistence of the
humoral response and its associated neutralisation capacity in recovered patients, and the
long-term health consequences of the infection. The French national COVID-SeroPRIM survey
aims to estimate the seroprevalence of IgG antibodies to SARS-CoV-2 in four populations of
primary care health professionals: primary care physicians (general practitioners and
paediatricians), health professionals working in city pharmacies (pharmacists and
compounders) and in dental practices (dentists and dental assistants). Indeed, the majority
of published studies target healthcare professionals in hospitals. It is therefore essential
to provide new knowledge on the exposure of primary care workers to the virus in order to
assess the impact of the pandemic, the level of immunity and the risk factors for exposure to
the virus. These data will be very useful for public health decision makers to better adapt
health protocols and provide useful information to better guide future vaccination campaigns.
Assuming that vaccination against COVID-19 will start in January 2021, data on the
vaccination rate of health professionals and their households will also be collected and made
available to policy makers in a timely manner. This study will be conducted in collaboration
with four primary care research and/or monitoring networks: the Sentinelles network (general
practitioners), the Association de Formation Professionnelle en Pédiatrie (Association for
Professional Training in Paediatrics), IQVIA (general practitioners and pharmacies), and the
Réseau de Recherche Clinique en Odontologie Libérale (ReCOL, dental surgeons) Seroprevalence
will be estimated using a high-sensitivity ELISA designed to detect SARS-CoV-2 specific IgG
antibodies in humoral fluid and a high-specificity seroneutralisation test to assess
seropositivity (i.e. excluding false positive ELISA results due to cross-reactivity with
other coronaviruses) and to assess SARS-CoV-2 neutralising antibody levels. These techniques
have already been used in two general population cohort studies (SAPRIS-SERO and EpiCoV) with
the objective of describing SARS-CoV-2 seroprevalence and risk factors. The secondary
objectives of the COVID-SeroPRIM study will be to assess the seroprevalence of IgG antibodies
to SARS-CoV-2 in household contacts of health care workers, to identify risk factors for
seropositivity to SARS-CoV-2, and to retrospectively describe the symptoms experienced by
individuals diagnosed with COVID-19. Due to the use of the same methodology to assess
seroprevalence, these results will be broadly complementary and comparable to those of
seroepidemiological studies conducted in the general population, such as EpiCOV and
SAPRIS-SERO. These surveys (EpiCOV, SAPRIS-SERO and COVID-SeroPRIM) as a whole are based on
similar questionnaires and identical serological methods and will provide many health
indicators such as the proportion of people who presented symptoms, who consulted for a
suspicion of COVID-19, who were screened but also who did not seek care in the recent period.
The COVID-SeroPRIM study, by targeting primary care health professionals and their
households, will provide data to reinforce the knowledge from SAPRIS-SERO and EpiCOV and to
better understand the dynamics of the epidemic in these four populations in order to guide
public policy makers.
This project has received funding from the French National Research Agency (ANR) as part of
the COVID-19 call for research projects, which aims to support urgent and rapid projects
whose results could be implemented in society in the coming months.
Main objective To estimate the seroprevalence of IgG antibodies to SARS-CoV-2 in four
distinct populations of primary care health professionals (general practitioners,
paediatricians, health professionals practising in city pharmacies and dental practices) in
metropolitan France.
Description:
Primary endpoint
- Estimation of the prevalence of healthcare professionals with IgG antibodies to SARS-CoV-2
in each of the four study populations (general practitioners, paediatricians, healthcare
professionals practising in community pharmacies and dental practices).
Secondary endpoint
- Comparison of the estimated prevalence of IgG antibodies to SARS-CoV-2 between each
healthcare professional population and the general population (EpiCOV and SAPRIS-SERO
studies);
- Comparison of the estimated prevalence of IgG antibodies to SARS-CoV-2 between the four
healthcare worker populations studied;
- Estimation of the prevalence of household contacts of healthcare workers with IgG
antibodies to SARS-CoV-2;
- Estimation of the prevalence of neutralising antibodies to SARS-CoV-2;
- Estimating the prevalence of vaccine-acquired antibodies among health workers and their
household contacts;
- Measurement of the association between SARS-CoV-2 IgG seropositivity and the
characteristics (socio-demographic data, implementation of hygiene measures,
professional practices, etc.) of the health professionals participating in the study;
- Measure of association between SARS-CoV-2 IgG seropositivity and characteristics
(socio-demographics, adherence to hygiene measures, work practices, etc.) among members
of health workers' households;
- Proportion of a- and paucisymptomatic forms in study participants;
- To retrospectively describe the symptoms reported by health workers and their household
members with a biologically confirmed diagnosis of COVID-19.
Target populations First phase The target populations are all four of the following
healthcare professional populations: general practitioners, paediatricians, healthcare
professionals practising in city pharmacies (pharmacists and dispensing chemists) and in
dental practices (dental surgeons and dental assistants) who are self-employed in
metropolitan France at the time of their inclusion in the study (planned for January 2021)
The source populations are general practitioners, paediatricians, health professionals
practising in city pharmacies (pharmacists and dispensing chemists) and in dental practices
(dental surgeons and dental assistants) who are self-employed in metropolitan France, and who
are affiliated to the following four health professional networks at the time of their
inclusion in the study: Sentinelles, AFPA, IQVIA, and ReCOL networks.
Second phase Household members of primary care health professionals The target population is
all the members of the households of the following four populations of healthcare
professionals: general practitioners, paediatricians, healthcare professionals practising in
town pharmacies (pharmacists and dispensing chemists) and in dental practices (dental
surgeons and dental assistants) who are self-employed in metropolitan France at the time of
their inclusion in the study. The source population is made up of members of households of
general practitioners, paediatricians, health professionals practising in city pharmacies
(pharmacists and dispensing chemists) and in dental practices (dental surgeons and dental
assistants) who are members of a network of health professionals listed below, and who are
participating in phase 1 of the COVID-SeroPRIM study: Sentinelles, AFPA, IQVIA, and ReCOL
networks.
