Sars-CoV2SEROPHUGACNCT04422977
Serological Study of the Exposure of Personnel to COVID-19
A study testing Sars-Cov-2 serology in people with Sars-CoV2, run by Centre Hospitalier Saint Joseph Saint Luc de Lyon at 1 site in France.
Trial summary
A seroconversion test for SARS-Cov-2 will be offered to all the employees of a care institution, which has treated 240 patients hospitalized for COVID disease between 28/02 and 30/04/2020. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Sars-CoV2
- What is being tested?
- Sars-Cov-2 serology
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 957 participants
- Where
- 1 siteFrance
- Study dates
- 8 Jun 2020to 10 Jul 2020
- 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 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subject who worked at Saint Joseph Saint Luke's Hospital during the epidemic wave (male or female).
- Free and informed consent
- Social security affiliation
Who cannot join
- Subject refusal
- Subject on leave during the entire period
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Serological Study of the Exposure of Personnel to Sars-cov-2 in an Urban Hospital Two Months After Managing an Influx of COVID Patients 19
A seroconversion test for SARS-Cov-2 will be offered to all the employees of a care institution, which has treated 240 patients hospitalized for COVID disease between 28/02 and 30/04/2020. The seroconversion test will be with a questionnaire to determine:
- whether the subject has shown signs of infection in the last 3 recent months
- if the subject has been in contact with COVID-diagnosed subjects (RT-PCR diagnosis or scanner) outside of the activity or within the professional activity (patient or colleague)
- Working conditions during the period
- The level of knowledge and respect of the barrier measures practices.
- Respect for distance during meals professional. Overall seroprevalence and stratified seroprevalence by care and administrative areas will be determined.
- Conditions
- Sars-CoV2
- Being tested
- Sars-Cov-2 serology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sars-Cov-2 serologyDiagnostic test
Also called serology
Measurement of overall seroprevalence of SARS-Cov-2 in an hospital staff
| Study group | Role | What they receive |
|---|---|---|
| CoVID exposure | Other | Not described Receives: Diagnostic Test: Sars-Cov-2 serology |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of overall seroprevalence of SARS-Cov-2 in an hospital staff with a seroconversion test for SARS-Cov-2
Measurement of overall seroprevalence of SARS-Cov-2 in an hospital staff
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2020
- Study start8 Jun 2020
- Primary completion10 Jul 2020
- Study completion10 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sars-CoV2Studies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 957 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Saint Joseph Saint Luc de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04422977
- Sponsor's protocol ID
- SEROPHUGAC
- Acronym
- SEROPHUGAC
- Status last verified
- Apr 2024
- First submitted
- 5 Jun 2020
- Last updated
- 4 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Vivier E, Pariset C, Rio S, Armand S, Doroszewski F, Richard D, Chardon M, Romero G, Metral P, Pecquet M, Didelot A. Specific exposure of ICU staff to SARS-CoV-2 seropositivity: a wide seroprevalence study in a French city-center hospital. Ann Intensive Care. 2021 May 13;11(1):75. doi: 10.1186/s13613-021-00868-8.
PubMed 33987718
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serological Study of the Exposure of Personnel to Sars-cov-2 in an Urban Hospital Two Months After Managing an Influx of COVID Patients 19
- ClinicalTrials.gov ID
- NCT04422977
- Acronym / sponsor ID
- SEROPHUGAC / SEROPHUGAC
- Conditions
- Sars-CoV2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 957 participants (actual)
- Lead sponsor
- Centre Hospitalier Saint Joseph Saint Luc de LyonUniversity, hospital or other
- Study start
- 8 Jun 2020 (actual)
- Primary completion
- 10 Jul 2020 (actual)
- Study completion
- 10 Jul 2020 (actual)
- First posted
- 9 Jun 2020 (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 seroconversion test for SARS-Cov-2 will be offered to all the employees of a care institution, which has treated 240 patients hospitalized for COVID disease between 28/02 and 30/04/2020. The seroconversion test will be with a questionnaire to determine:
- whether the subject has shown signs of infection in the last 3 recent months
- if the subject has been in contact with COVID-diagnosed subjects (RT-PCR diagnosis or scanner) outside of the activity or within the professional activity (patient or colleague)
- Working conditions during the period
- The level of knowledge and respect of the barrier measures practices.
- Respect for distance during meals professional. Overall seroprevalence and stratified seroprevalence by care and administrative areas will be determined.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CoVID exposure | Other | Diagnostic Test: Sars-Cov-2 serology |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subject who worked at Saint Joseph Saint Luke's Hospital during the epidemic wave (male or female).
Key exclusion criteria (2 listed)
- Subject refusal
- Subject on leave during the entire period
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 serologyAlso: serologyMeasurement of overall seroprevalence of SARS-Cov-2 in an hospital staff | Diagnostic test | CoVID exposure |
Primary outcome
Measurement of overall seroprevalence of SARS-Cov-2 in an hospital staff with a seroconversion test for SARS-Cov-2
Time frame: 1 month
Measurement of overall seroprevalence of SARS-Cov-2 in an hospital staff
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 4 Apr 2024.
- Derived from this study: PubMed 33987718Vivier E, Pariset C, Rio S, Armand S, Doroszewski F, Richard D, Chardon M, Romero G, Metral P, Pecquet M, Didelot A. Specific exposure of ICU staff to SARS-CoV-2 seropositivity: a wide seroprevalence study in a French city-center hospital. Ann Intensive Care. 2021 May 13;11(1):75. doi: 10.1186/s13613-021-00868-8.
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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?
A study testing Sars-Cov-2 serology in people with Sars-CoV2, run by Centre Hospitalier Saint Joseph Saint Luc de Lyon 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 3 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 4 Apr 2024. 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?
Measurement of overall seroprevalence of SARS-Cov-2 in an hospital staff with a seroconversion test for SARS-Cov-2 (time frame: 1 month). 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 NCT04422977, which also lists 1 linked publication.
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 4 Apr 2024.