COVID-19 InfectionNCT04964024
SaRS-Cov-2 Antibodies Following Exposure to Coronavirus Disease 2019 (COVID-19) and/or Vaccination in Nursing Homes
An observational study of COVID-19 Infection, run by Central Hospital, Nancy, France at 1 site in France.
Trial summary
Presence of SaRS-Cov-2 antibodies following exposure to Coronavirus Disease 2019 (COVID-19) and/or vaccination is a major indicator of immunization. Few data exit about serology response in nursing homes (NHs), i.e. in the most vulnerable population for developing severe forms of the disease. Read more about this study
- Who is it for?
- Ages 20 to 110 yearsHealthy volunteers can take part
- Conditions the study is for
- COVID-19 Infection
- What is being tested?
- SARS-CoV-2 antibodies
- Type of treatment
- Vaccines
- How many people
- 1,293 participants
- Where
- 1 siteFrance
- Study dates
- 15 Jul 2021to 15 May 2022
- 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 20 to 110 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Residents of the 9 Nursing Homes that participate in this study Health professionals working these Nursing Homes
Who may be able to join
- For Residents:
- Living in one of the 9 Nursing Homes that participate in this study
- Having a SARS-COV-2 post vaccination serology.
- Having no objection for using the results of the serology for the purpose of this analysis
- For Health Professionals:
- Working in one of the 9 Nursing Homes that participate in this study,
- Having a SARS-COV-2 post vaccination serology.
- Having no objection for using the results of the serology for the purpose of this analysis
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
France1 site
CHRU de Nancy, Université de Lorraine
Vandœuvre-lès-Nancy, US and Canada Only, 54500
About this study
Official title: SaRS-Cov-2 Antibodies Following Exposure to COVID-19 and/or Vaccination in Nursing Homes
Presence of SaRS-Cov-2 antibodies following exposure to Coronavirus Disease 2019 (COVID-19) and/or vaccination is a major indicator of immunization. Few data exit about serology response in nursing homes (NHs), i.e. in the most vulnerable population for developing severe forms of the disease.
Residents and health professionals in 9 nursing homes (NHs) with SaRS-Cov-2 antibodies detection after exposure (either COVID-19 or vaccine) All biological tests were performed in the frame of the standard care of residents and health professionals and all participants did not express opposition for using anonymously their data for the purpose of this academic analysis. In addition all Directors and Physicians of these NHs accepted to participate in this study
- Conditions
- COVID-19 Infection
- Being tested
- SARS-CoV-2 antibodies
- Keywords
- SARS-CoV-2, Antibodies, Vaccination, Nursing Homes
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SARS-CoV-2 antibodiesDiagnostic test
Analysis of the results of the serological response to COVID-19 and/or Vaccine
| Study group | Role | What they receive |
|---|---|---|
| Residents in Nursing homes | Not described Receives: Diagnostic Test: SARS-CoV-2 antibodies | |
| Health professionals in Nursing homes | Not described Receives: Diagnostic Test: SARS-CoV-2 antibodies |
What is being measured
The primary outcome is the main question the study is designed to answer.
Levels of SARS-COV-2 antibodies
Study of the SARS-COV-2 antibodies according to the history of COVID-19 and vaccinal status in Nursing Home residents and in health professionals
Measured: Through study completion average 6 months Retrospective analysis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2021
- Study start15 Jul 2021
- Primary completion15 May 2022
- Study completion15 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19 InfectionStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,293 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pr Athanase BENETOS, Central Hospital, Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04964024
- Sponsor's protocol ID
- EHPAD-COVID-19
- Status last verified
- Jul 2022
- First submitted
- 26 Jun 2021
- Last updated
- 19 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The database can be used by other groups but only for academic purposes
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SaRS-Cov-2 Antibodies Following Exposure to COVID-19 and/or Vaccination in Nursing Homes
- ClinicalTrials.gov ID
- NCT04964024
- Acronym / sponsor ID
- EHPAD-COVID-19
- Conditions
- COVID-19 Infection
- Keywords
- SARS-CoV-2, Antibodies, Vaccination, Nursing Homes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,293 participants (actual)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 15 Jul 2021 (actual)
- Primary completion
- 15 May 2022 (actual)
- Study completion
- 15 May 2022 (actual)
- First posted
- 15 Jul 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.
Presence of SaRS-Cov-2 antibodies following exposure to Coronavirus Disease 2019 (COVID-19) and/or vaccination is a major indicator of immunization. Few data exit about serology response in nursing homes (NHs), i.e. in the most vulnerable population for developing severe forms of the disease.
Residents and health professionals in 9 nursing homes (NHs) with SaRS-Cov-2 antibodies detection after exposure (either COVID-19 or vaccine) All biological tests were performed in the frame of the standard care of residents and health professionals and all participants did not express opposition for using anonymously their data for the purpose of this academic analysis. In addition all Directors and Physicians of these NHs accepted to participate in this study
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Residents in Nursing homes | – | Diagnostic Test: SARS-CoV-2 antibodies |
| Health professionals in Nursing homes | – | Diagnostic Test: SARS-CoV-2 antibodies |
Who may qualify
- Ages
- 20 to 110 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Residents of the 9 Nursing Homes that participate in this study Health professionals working these Nursing Homes
Key inclusion criteria (8 listed)
- Living in one of the 9 Nursing Homes that participate in this study
- Having a SARS-COV-2 post vaccination serology.
- Having no objection for using the results of the serology for the purpose of this analysis
- Working in one of the 9 Nursing Homes that participate in this study,
- Having a SARS-COV-2 post vaccination serology.
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| SARS-CoV-2 antibodiesAnalysis of the results of the serological response to COVID-19 and/or Vaccine | Diagnostic test | Health professionals in Nursing homes, Residents in Nursing homes |
Primary outcome
Levels of SARS-COV-2 antibodies
Time frame: Through study completion average 6 months Retrospective analysis
Study of the SARS-COV-2 antibodies according to the history of COVID-19 and vaccinal status in Nursing Home residents and in health professionals
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2022.
- Individual participant dataSharing planned: Undecided. The database can be used by other groups but only for academic purposes
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19 Infection, run by Central Hospital, Nancy, 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 8 inclusion and 1 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 19 Jul 2022. 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?
Levels of SARS-COV-2 antibodies (time frame: Through study completion average 6 months Retrospective analysis). 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 19 Jul 2022.