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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05336604
Other study ID # C20-25
Secondary ID 2020-A01191-38
Status Recruiting
Phase
First received
Last updated
Start date May 2, 2020
Est. completion date August 30, 2022

Study information

Verified date February 2022
Source Institut National de la Santé Et de la Recherche Médicale, France
Contact Josiane Warszawski, MD, PhD
Phone 01 49 59 53 05
Email josiane.warszawski@inserm.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

EpiCov is a population-based cohort which aims to provide national and regional estimates of seroprevalence of SARS-CoV-2 infection and analyse relations between living conditions and the dynamics of the epidemic in France. The study population is a random sample of individuals aged 15 years and older, excluding people living in residences for the elderly and living in jail. The participants are recruited from the French national tax register and is representative of the population living in France. Home self-samples on Dried Blood Spots (DBS) for IgG and neutralizing antibodies detection were offered to a random national sub-sample of 12,114 in the 1st round of the EPICOV survey (May 2020) and to all respondents in the 2nd round (November 2020), including also serological testing for all members (≥ 6 years old) of household for 20% of index participants. A third round was perfomed in June-July 2021, without serological measurements. Overall, 134,391 participants have been enrolled in first-round (May 2020). Among them, 107 759 participated to the second round (November 2020) and 85 074 in third round (June 2021). The next wave is expected in March-april 2022.


Recruitment information / eligibility

Status Recruiting
Enrollment 134391
Est. completion date August 30, 2022
Est. primary completion date August 9, 2021
Accepts healthy volunteers No
Gender All
Age group 15 Years and older
Eligibility Inclusion Criteria: - individuals aged 15 years or older - living on January 1, 2020, in mainland France or one of three overseas departments (Martinique, Guadeloupe and Réunion Island). Exclusion Criteria: - individuals living in prisons at the time of the study - people living in residential institutions for dependent elderly persons, as caregivers were not available during the epidemic period to help them with internet access or phone calls.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
France Inserm U1018 Le Kremlin-Bicêtre

Sponsors (2)

Lead Sponsor Collaborator
Institut National de la Santé Et de la Recherche Médicale, France Ministry of Health, France

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Changes in COVID-19 Seroprevalence over time Proportion of the individuals tested with an Euroimmun ELISA-S ratio >1.1 (ELISA S+), from home self-sampling on capillarous blood sampled.
Serological tests was based on a capillarous blood samples collected by the participants themselves, at home, from a finger prick dried blood spot 903 Whatman paper (DBS) kits, which was subsequently analyzed in a centralized virology laboratory. The sample kits were delivered by express mail to each participant who had sent their samples by mail to the EpiCov biobank. At the biobank, DBS cards were punched from the spots on the Whatman paper, using a PantheraTM machine (PerkinElmer). The tubes were sent to the virology laboratory (Unité des virus Emergents, Inserm/IRD, Marseille, France), in order to detect IgG antibodies against the spike protein (Euroimmun ELISA-S), and neutralizing antibodies for non-negative ELISA-S.
Inclusion, 6 months, 14 months, 28 months
Primary Changes in living condition Questions relating to living conditions were included: socioeconomic characteristics, size and nature of the habitation, number of people in the household, working condition, childcare, home-schooling, inter-partner relationships within the household Inclusion, 6 months, 14 months, 28 months
Primary Changes in health condition Health status was described through general and specific questions regarding self-perceived health, symptoms potentially linked to COVID-19, mental health, and access to healthcare, whether or not linked to COVID-19. Inclusion, 6 months, 14 months, 28 months
Primary COVID-19 IgG antibodies median Median of Euroimmun ELISA-S IgG, from home self-sampling on capillarous blood sampled. 28 months
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