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General PopulationEpiCovNCT05336604

STUDY OF THE COVID-19 EPIDEMIC AND SOCIO-ECONOMIC LIVING CONDITIONS IN FRANCE

An observational study of General Population, run by Institut National de la Santé Et de la Recherche Médicale, France at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 15 years and older
Conditions the study is for
General Population
How many people
134,391 participants
Where
1 siteFrance
Study dates
2 May 2020to 4 May 2023
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 15 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: Population-based sample based on a national random probability sample from the administrative sample frame: all individuals aged 15 years or older on January 1, 2020, living in mainland France or one of three overseas departments (Martinique, Guadeloupe and Réunion Island). Due to the poor quality of the sampling frame, poor internet access and the use of multiple languages, two other overseas departments, French Guiana and Mayotte, were excluded from the study.

Who may be able to join

  • 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).

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

France1 site

  • Inserm U1018

    Le Kremlin-Bicêtre

Other trials in France

About this study

Official title: Epidémiologie et Conditions de Vide liées au Covid-19 STUDY OF THE COVID-19 (SARS-CoV-2) EPIDEMIC AND SOCIO-ECONOMIC LIVING

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.

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT05336604
Study groupRoleWhat they receive
General population, aged 15 years or more, living in FrancePopulation-based ohort of general population, aged 15 years or more, living in France in May 2020, selected at random from national administrative sample frame

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Inclusion, 6 months, 14 months, 28 months

  2. 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

    Measured: Inclusion, 6 months, 14 months, 28 months

  3. 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.

    Measured: Inclusion, 6 months, 14 months, 28 months

  4. COVID-19 IgG antibodies median

    Median of Euroimmun ELISA-S IgG, from home self-sampling on capillarous blood sampled.

    Measured: 28 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Apr 2022
  2. Study start2 May 2020
  3. Primary completion9 Aug 2021
  4. Study completion4 May 2023

Resources

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
134,391 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05336604
Sponsor's protocol ID
C20-25
Other IDs
2020-A01191-38
Acronym
EpiCov
Status last verified
Jul 2024
First submitted
4 Apr 2022
Last updated
8 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: The EpiCov data is available for research purpose, 9 months after overall completion of one round. Access to anonymized individual data may be available before the planned period of open access : specific project has to be presented to the EpiCov exploitation committee : if accepted, it needs approval of ethics and reglementary Committee for researchers who meet the criteria for access to data. The first round, and will be available by March 2022 concerning the second round for research purpose on CASD (https://www.casd.eu/), after submission to approval of French Ethics and Regulatory Committee procedure (Comité du Secret Statistique, CESREES and CNIL).

Publications

  • Melchior M, Florence AM, Davisse-Paturet C, Falissard B, Galera C, Hazo JB, Vuillermoz C, Warszawski J, Dione F, Rouquette A. Labor market participation and depression during the COVID-19 pandemic among young adults (18 to 30 years): A nationally representative study in France. Front Public Health. 2022 Oct 24;10:904665. doi: 10.3389/fpubh.2022.904665. eCollection 2022.

    PubMed 36353287

  • Bajos N, Spire A, Silberzan L, Sireyjol A, Jusot F, Meyer L, Franck JE, Warszawski J; EpiCov study group. When Lack of Trust in the Government and in Scientists Reinforces Social Inequalities in Vaccination Against COVID-19. Front Public Health. 2022 Jul 20;10:908152. doi: 10.3389/fpubh.2022.908152. eCollection 2022.

    PubMed 35937246

  • Silberzan L, Martin C, Bajos N; EpiCov Study Group. Social Isolation Among Older Adults in the Time of COVID-19: A Gender Perspective. Front Public Health. 2022 Jun 9;10:840940. doi: 10.3389/fpubh.2022.840940. eCollection 2022.

    PubMed 35757612

  • Warszawski J, Meyer L, Franck JE, Rahib D, Lydie N, Gosselin A, Counil E, Kreling R, Novelli S, Slama R, Raynaud P, Bagein G, Costemalle V, Sillard P, Fourie T, de Lamballerie X, Bajos N; Epicov Team. Trends in social exposure to SARS-Cov-2 in France. Evidence from the national socio-epidemiological cohort-EPICOV. PLoS One. 2022 May 25;17(5):e0267725. doi: 10.1371/journal.pone.0267725. eCollection 2022.

    PubMed 35613100

  • Warszawski J, Beaumont AL, Seng R, de Lamballerie X, Rahib D, Lydie N, Slama R, Durrleman S, Raynaud P, Sillard P, Beck F, Meyer L, Bajos N; EPICOV study group. Prevalence of SARS-Cov-2 antibodies and living conditions: the French national random population-based EPICOV cohort. BMC Infect Dis. 2022 Jan 9;22(1):41. doi: 10.1186/s12879-021-06973-0.

    PubMed 35000580

Questions about this trial

What is this clinical trial studying?

An observational study of General Population, run by Institut National de la Santé Et de la Recherche Médicale, France at 1 site in France.

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 2 inclusion and 2 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: finished, as of the sponsor's last update on 8 Jun 2026. 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 France. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in COVID-19 Seroprevalence over time (time frame: Inclusion, 6 months, 14 months, 28 months). The study lists 4 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 NCT05336604, which also lists 5 linked publications.

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 8 Jun 2026.

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