SARS-COV-2NCT04932837
Level of Immunity, Neutralization of the COVID-19 Virus and Reinfections in Residents of 2 Migrant Workers' Residences
An observational study of SARS-COV-2, run by Epicentre at 2 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- SARS-COV-2
- What is being tested?
- Blood and Saliva collection
- How many people
- 0 participants
- Where
- 2 sitesFrance
- Study dates
- 14 Jun 2021to 2 Jul 2021
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: residents of 2 Migrant Workers
Who may be able to join
- 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
Who cannot join
- Unwillingness to provide informed consent
- Unwillingness to provide blood
- Contraindication to venepuncture
Trial locations and contacts
2 sites in 1 country.
France2 sites
Foyer de travailleurs migrants
Montreuil, Île-de-France Region, 93
Foyer de travailleurs migrants
Villemomble, Île-de-France Region, 93
About this study
Official title: Determination of the Level of Immunity, Neutralization of the SARS-COV-2 Virus and Reinfections in Residents of 2 Migrant Workers' Residences 10 Months Apart
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.
- Conditions
- SARS-COV-2
- Being tested
- Blood and Saliva collection
- Keywords
- COVID-19, migrant workers' residences, Immunity, protection
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood and Saliva collectionBiological
Serological, viral RNA and antigenic test
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Biological: Blood and Saliva collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 15 days
Secondary outcomes (3)
Immunity and protection
- Identify potential reinfections (reported symptoms confirmed by positive PCR tests) or resurgence of symptoms (long COVID) among residents who were seropositive in July 2020
- Assess the evolution of antibodies (IgA, IgM, IgG) approximately 10 months after the first test in Sars-CoV-2 seropositive individuals in July
- To evaluate the neutralizing and therefore protective activity of the re-measured antibodies, and their level of affinity maturation to SARS-COV-2 as well as their efficacy against the mainly circulating variants: B.1.1.7 (UK), B.1.351 (South Africa) and P.1 (Brazil)
Measured: 15 days
New infections and screening
- Estimate the proportion of infections (reported symptoms and/or positive PCR tests)/exposure to the virus in people newly arrived since September 2020
- In case of SARS-COV-2 RNA detection, characterize the virus subtype (genomic sequencing)
- Document the turnover in MWR populations to guide MSF activities in the future
Measured: 15 days
COVID Vaccination
- Assess the proportion of participants already vaccinated or interested in the future COVID vaccination campaign and document the reasons for those who express doubts or plan to refuse vaccination
- To evaluate the performance of the LuLISA technique for the response to SARS-CoV-2 N and S proteins
- To evaluate the performance of a rapid serological test on strip, LuLISA Stripe developed by the Institute Pasteur by comparison to the LuLISA technique
- To evaluate the performance of a rapid N and S antigenic test on saliva, LuLISA Flash, developed by the Institut Pasteur, by comparing it to the RT-PCR method
- To evaluate the performance of an alternative antigenic test on saliva with very high sensitivity, LuLISA Stick, developed by Institute Pasteur, by comparing it to the RT-PCR method
- Evaluate the performance of a rapid molecular RT-LAMP test developed by Institute Pasteur (depending on availability) by comparing it to the RT-PCR method
Measured: 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2021
- Study start14 Jun 2021 (estimated)
- Primary completion25 Jun 2021 (estimated)
- Study completion2 Jul 2021 (estimated)
Why it stopped: The vaccination campaign started before the approval of the ethics committee was obtained. The study is therefore no longer of interest to be carried out.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SARS-COV-2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Epicentre
- Sponsor type
- University, hospital or other
- Collaborators
- Medecins Sans Frontieres, Netherlands, Institut Pasteur, Agence Regionale de Sante d'Ile de France
- Responsible party
- Sponsor
- Investigators
- Elisabeth POULET, MD, Principal investigator, Epicentre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04932837
- Sponsor's protocol ID
- 811562
- Status last verified
- Jun 2021
- First submitted
- 1 Jun 2021
- Last updated
- 21 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of the Level of Immunity, Neutralization of the SARS-COV-2 Virus and Reinfections in Residents of 2 Migrant Workers' Residences 10 Months Apart
- ClinicalTrials.gov ID
- NCT04932837
- Acronym / sponsor ID
- 811562
- Conditions
- SARS-COV-2
- Keywords
- COVID-19, migrant workers' residences, Immunity, protection
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: The vaccination campaign started before the approval of the ethics committee was obtained. The study is therefore no longer of interest to be carried out.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- EpicentreUniversity, hospital or other
- Collaborators
- Medecins Sans Frontieres, Netherlands, Institut Pasteur, Agence Regionale de Sante d'Ile de France
- Study start
- 14 Jun 2021 (estimated)
- Primary completion
- 25 Jun 2021 (estimated)
- Study completion
- 2 Jul 2021 (estimated)
- First posted
- 21 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| migrant worker residents | – | Biological: Blood and Saliva collectionThe 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- residents of 2 Migrant Workers
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- Unwillingness to provide informed consent
- Unwillingness to provide blood
- Contraindication to venepuncture
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood and Saliva collectionSerological, viral RNA and antigenic test | Biological | migrant worker residents |
Primary outcome
Level and quality of current humoral immune protection in the residents of the two migrant workers' residences
Time frame: 15 days
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)
3 secondary outcomes
Immunity and protection
Time frame: 15 days
New infections and screening
Time frame: 15 days
COVID Vaccination
Time frame: 15 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2021.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elisabeth POULET, MD principal investigator
Epicentre
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of SARS-COV-2, run by Epicentre at 2 sites 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 3 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: withdrawn, as of the sponsor's last update on 21 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 was withdrawn before enrolling participants, so there are no results.
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?
Level and quality of current humoral immune protection in the residents of the two migrant workers' residences (time frame: 15 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Jun 2021.