COVID-19SERASYMPTONCT05128656
Immune Response of Asymptomatic EHPAD Employees Infected With COVID-19
A study testing serology in people with COVID-19, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The investigators performed in April 2020, a screening campaign of asymptomatic staff working in elderly nursing homes in Paris France (EHPAD), where the virus had been circulating actively in March and April 2020. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19
- What is being tested?
- serology
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteFrance
- Study dates
- 18 Jun 2022to 18 Jun 2022
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Refuse to participate or inability to obtain informed consent.
- under guardianship, curators
- negative SARS-COV-2 PCR
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Kinetic of Humoral Immune Response of Asymptomatic Nursing Homes (EHPAD) Employees Infected With Severe Acute Respiratory Syndrome Coronavirus : a Case Control Study
The investigators performed in April 2020, a screening campaign of asymptomatic staff working in elderly nursing homes in Paris France (EHPAD), where the virus had been circulating actively in March and April 2020. Among 241 employees tested in four nursing homes, 32 (13.2%) were asymptomatic carriers of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-Cov-2).
Few data are available concerning the humoral immune response of asymptomatic carriers, the elicitation and duration of neutralizing antibodies and the duration of protection.
The purpose of the study is to determine whether these asymptomatic persons develop a humoral immune response, whether this immune response is durable and whether it is protective against the risk of reinfection
Read the detailed description
The investigators performed in April 2020, a screening campaign of asymptomatic staff working in elderly nursing homes in Paris, France, where the virus had been circulating actively in March and April 2020. Among 241 employees tested in four nursing homes, 32 (13.2%) were asymptomatic carriers of SARS-Cov-2.
Few data are available concerning the humoral immune response of asymptomatic carriers, the elicitation and duration of neutralizing antibodies and the duration of protection.
The main objective of this study is to describe the SARS-Cov-2 asymptomatic employees with positive immunoglobulin G (igG) serology at month 1-2 post infection.
Secondary objectives are
- To describe the proportion of asymptomatic persons with SARS-Cov-2 antibodies month 3 and 6 post infection
- To compare the proportion of persons with SARS-Cov-2 antibodies between asymptomatic and asymptomatic carriers at M1-2 post infection, M3 and M6 post infection
- To determine the factors associated with the appearance of antibodies ( viral load, age, sex, previous history, habitus..)
- To study the neutralizing capacities and immune-profiling of SARS-Cov-2 antibodies in vitro
- To evaluate the occurrence of Coronavirus Disease 2019 (COVID-19) reinfections in asymptomatic carriers during the second wave.
The design will be a case control study between
- Cases: SARS-Cov-2 asymptomatic nursing homes employees
- Controls: cohort of patients with a symptomatic COVID-19, preferably recruited in nursing homes or in case of difficulties in the virology service of COCHIN Hospital.
- Conditions
- COVID-19
- Being tested
- serology
- Keywords
- EHPAD employees, COVID-19, asymptomatic, humoral response
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
serologyOther
serology at M3 and serology at M6
| Study group | Role | What they receive |
|---|---|---|
| Cases | Other | SARS-Cov-2 asymptomatic nursing homes employees Receives: Other: serology |
| Controls | Other | cohort of patients with a symptomatic COVID-19, preferably recruited in nursing homes or in case of difficulties in the virology service of COCHIN Hospital. Receives: Other: serology |
What is being measured
The primary outcome is the main question the study is designed to answer.
rate of positive IgG serology
positive IgG (Immunoglobulin G) SARS-Cov-2 serology after infection of asymptomatic employees
Measured: month 1-2 post infection
Secondary outcomes (5)
rate of positive IgG serology
positive IgG (Immunoglobulin G) SARS-Cov-2 serology after infection of asymptomatic employees
Measured: month 3-6 post infection
rate of positive immunoglobulin M (IgM) serology
positive IgM SARS-Cov-2 serology after infection of asymptomatic employees
Measured: month 1-2-3 and 6 post infection
rate of neutralizing antibodies
concentration of neutralizing antibodies
Measured: month 1-2-3 and 6 post infection
questionnaire
Associated factors with the presence of antibodies
Measured: month 1-2-3 and 6 post infection
re infection
of asymptomatic patients with SARS-Cov-2
Measured: through study completion, an average of 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2021
- Study start18 Jun 2022
- Primary completion18 Jun 2022
- Study completion18 Jun 2022
Why it stopped: Authorization denied by Ethical Comitee
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Case control longitudinal study, Interventional minimal risk study
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Institut Pasteur
- Responsible party
- Sponsor
- Investigators
- Dominique Salmon, MD, PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05128656
- Sponsor's protocol ID
- APHP201253
- Other IDs
- 2020-A01833-36
- Acronym
- SERASYMPTO
- Status last verified
- Oct 2022
- First submitted
- 19 Nov 2020
- Last updated
- 26 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Kinetic of Humoral Immune Response of Asymptomatic Nursing Homes (EHPAD) Employees Infected With Severe Acute Respiratory Syndrome Coronavirus : a Case Control Study
- ClinicalTrials.gov ID
- NCT05128656
- Acronym / sponsor ID
- SERASYMPTO / APHP201253
- Conditions
- COVID-19
- Keywords
- EHPAD employees, COVID-19, asymptomatic, humoral response
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Authorization denied by Ethical Comitee
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Institut Pasteur
- Study start
- 18 Jun 2022 (actual)
- Primary completion
- 18 Jun 2022 (actual)
- Study completion
- 18 Jun 2022 (actual)
- First posted
- 22 Nov 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.
The investigators performed in April 2020, a screening campaign of asymptomatic staff working in elderly nursing homes in Paris France (EHPAD), where the virus had been circulating actively in March and April 2020. Among 241 employees tested in four nursing homes, 32 (13.2%) were asymptomatic carriers of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-Cov-2).
Few data are available concerning the humoral immune response of asymptomatic carriers, the elicitation and duration of neutralizing antibodies and the duration of protection.
The purpose of the study is to determine whether these asymptomatic persons develop a humoral immune response, whether this immune response is durable and whether it is protective against the risk of reinfection
Detailed description
The investigators performed in April 2020, a screening campaign of asymptomatic staff working in elderly nursing homes in Paris, France, where the virus had been circulating actively in March and April 2020. Among 241 employees tested in four nursing homes, 32 (13.2%) were asymptomatic carriers of SARS-Cov-2.
Few data are available concerning the humoral immune response of asymptomatic carriers, the elicitation and duration of neutralizing antibodies and the duration of protection.
The main objective of this study is to describe the SARS-Cov-2 asymptomatic employees with positive immunoglobulin G (igG) serology at month 1-2 post infection.
Secondary objectives are
- To describe the proportion of asymptomatic persons with SARS-Cov-2 antibodies month 3 and 6 post infection
- To compare the proportion of persons with SARS-Cov-2 antibodies between asymptomatic and asymptomatic carriers at M1-2 post infection, M3 and M6 post infection
- To determine the factors associated with the appearance of antibodies ( viral load, age, sex, previous history, habitus..)
- To study the neutralizing capacities and immune-profiling of SARS-Cov-2 antibodies in vitro
- To evaluate the occurrence of Coronavirus Disease 2019 (COVID-19) reinfections in asymptomatic carriers during the second wave.
The design will be a case control study between
- Cases: SARS-Cov-2 asymptomatic nursing homes employees
- Controls: cohort of patients with a symptomatic COVID-19, preferably recruited in nursing homes or in case of difficulties in the virology service of COCHIN Hospital.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Case control longitudinal study, Interventional minimal risk study
| Arm | Type | Receives |
|---|---|---|
| Cases | Other | Other: serologySARS-Cov-2 asymptomatic nursing homes employees |
| Controls | Other | Other: serologycohort of patients with a symptomatic COVID-19, preferably recruited in nursing homes or in case of difficulties in the virology service of COCHIN Hospital. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (4 listed)
- Refuse to participate or inability to obtain informed consent.
- under guardianship, curators
- negative SARS-COV-2 PCR
- Pregnancy
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 |
|---|---|---|
| serologyserology at M3 and serology at M6 | Other | Cases, Controls |
Primary outcome
rate of positive IgG serology
Time frame: month 1-2 post infection
positive IgG (Immunoglobulin G) SARS-Cov-2 serology after infection of asymptomatic employees
5 secondary outcomes
rate of positive IgG serology
Time frame: month 3-6 post infection
rate of positive immunoglobulin M (IgM) serology
Time frame: month 1-2-3 and 6 post infection
rate of neutralizing antibodies
Time frame: month 1-2-3 and 6 post infection
questionnaire
Time frame: month 1-2-3 and 6 post infection
re infection
Time frame: through study completion, an average of 8 months
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 26 Oct 2022.
- Individual participant dataSharing planned: No
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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.
Dominique Salmon, MD, PhD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing serology in people with COVID-19, run by Assistance Publique - Hôpitaux de Paris 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 0 inclusion and 4 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 26 Oct 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 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?
rate of positive IgG serology (time frame: month 1-2 post infection). 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 26 Oct 2022.