NCT04932837

Brief Summary

A previous seroprevalence survey showed very high seroprevalence levels among residents of the two among the residents of the two migrant workers' hostels surveyed, indicating a high level of circulation of the virus SARS-COV-2 during the 1st wave of COVID-19. The constitution of a cohort after the event would be an opportunity to obtain opportunity to obtain answers to crucial questions: duration of immunity, potential reinfections potential reinfections, potential re-clustering. Going back to check the serological status seems feasible, especiallyespecially in the Foyers de Travailleurs Migrants (high probability of finding the participants). There is an obvious scientific interest around the duration of immunity and reinfections in a population highly exposed during the first wave. Several articles document the decline of IgG antibodies in the months following an infection, but very few infection, but very few evaluate the protective character in the medium term (\>=6 months), especially in asymptomatic individuals. We are also concerned about the circulation of We are also concerned about the circulation of new variants and the immunity acquired after infection in residents. To date, no study on the duration of immunity has been conducted in migrant worker's residences.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jun 2021

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 1, 2021

Completed
13 days until next milestone

Study Start

First participant enrolled

June 14, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 21, 2021

Completed
4 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 25, 2021

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 2, 2021

Completed
Last Updated

June 21, 2021

Status Verified

June 1, 2021

Enrollment Period

11 days

First QC Date

June 1, 2021

Last Update Submit

June 17, 2021

Conditions

Keywords

COVID-19migrant workers' residencesImmunityprotection

Outcome Measures

Primary Outcomes (1)

  • Level and quality of current humoral immune protection in the residents of the two migrant workers' residences

    To assess the level and quality of current humoral immune protection in the residents of the two migrant workers' residences in Villemomble and Montreuil who were included in the 1st seroprevalence study in July 2020, approximately 10 months later (May 2021)

    15 days

Secondary Outcomes (3)

  • Immunity and protection

    15 days

  • New infections and screening

    15 days

  • COVID Vaccination

    15 days

Study Arms (1)

migrant worker residents

The target population will be the 124 residents in the 2 migrant worker residences who were included in the previous seroprevalence study and those who arrived at the 2 residences since September 1st, 2020

Biological: Blood and Saliva collection

Interventions

Serological, viral RNA and antigenic test

migrant worker residents

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

residents of 2 Migrant Workers

You may qualify if:

  • All individuals who consented to participate in the 1st study and who consent to participate in this study
  • All individuals 18 years of age or older not residing in the 2 MWRs in July 2020 and permanently living in the MWR since September 2020 who consent to participate in this study

You may not qualify if:

  • Unwillingness to provide informed consent
  • Unwillingness to provide blood
  • Contraindication to venepuncture

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Foyer de travailleurs migrants

Montreuil, Île-de-France Region, 93, France

Location

Foyer de travailleurs migrants

Villemomble, Île-de-France Region, 93, France

Location

MeSH Terms

Conditions

COVID-19

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Elisabeth POULET, MD

    Epicentre

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 1, 2021

First Posted

June 21, 2021

Study Start

June 14, 2021

Primary Completion

June 25, 2021

Study Completion

July 2, 2021

Last Updated

June 21, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will share

The research team will develop a range of activities to disseminate the study findings. These dissemination activities will be coordinated by MSF and Epicentre. The results will be presented in an internal report and an external report for the Ministry of Health (MoH), the French National Public Health Agency and Institute Pasteur. An abstract of the findings will be submitted for presentation at a scientific conference, and at least one manuscript will be submitted for publication in a peer-reviewed scientific journal. The findings of the survey will also be used for advocacy purposes, in coordination with community leaders of participating communities. The results of the survey (lay version of the report), and their possible use for advocacy / communication, will be shared with the staff, resident representatives and residents of the MWRs, whether or not they actually participated in the study.

Shared Documents
CSR

Locations