COVID-19SeroPrevHUSNCT05652582
Seroprevalence of Covid-19 in the Staff of the University Hospitals of Strasbourg
An observational study of COVID-19, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
The Grand Est region is one of the most affected regions in France during the first wave of the COVID-19 epidemic. A significant increase in the number of patients hospitalized for SARS-CoV 2 infection at the University Hospitals of Strasbourg (HUS) led to a sudden saturation of their capacities. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19
- How many people
- 5,694 participants
- Where
- 1 siteFrance
- Study dates
- 24 Jun 2021to 24 Jun 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 18 years and older
- All sexes
- Adult, Older adult
Study population: Hospital staff practicing at HUS who performed SARS-CoV 2 serology in the period from 06/22/2020 to 11/1/2020
Who may be able to join
- Adult subject (≥ 18 years of age)
- Hospital staff practicing at HUS who performed SARS-CoV 2 serology in the period from 06/22/2020 to 11/1/2020
Who cannot join
- Subject not meeting inclusion criteria
Trial locations and contacts
1 site in 1 country.
France1 site
Service Laboratoire de Virologie - PTM - CHU de Strasbourg - France
Strasbourg, 67091
About this study
Official title: Seroprevalence of SARS-CoV 2 in the Staff of the University Hospitals of Strasbourg
The Grand Est region is one of the most affected regions in France during the first wave of the COVID-19 epidemic. A significant increase in the number of patients hospitalized for SARS-CoV 2 infection at the University Hospitals of Strasbourg (HUS) led to a sudden saturation of their capacities. Hospital workers appear to be a population at particular risk for this new infectious agent. The percentage of hospital workers who have been in contact with the virus or have contracted COVID-19 is unknown.
The objective of this work is to determine the prevalence of SARS-CoV-2 positive serologies among hospital staff screened from June 22, 2020 to November 1, 2020 following a screening campaign offering serological testing to all volunteer HUS professionals.
- Conditions
- COVID-19
- Keywords
- COVID-19, SARS-COV-2, Prevalence of SARS-CoV-2
- Medical subject headings
- COVID-19
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the positive seroprevalence of SARS-CoV-2 among hospital staff screened from June 22, 2020 to November 1, 2020
Seroprevalence will be estimated by calculating the rate of seropositive subjects with its 95% confidence interval
Measured: Files analysed retrospectively from June 22, 2020 to November 1, 2020 will be examined
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2022
- Study start24 Jun 2021
- Primary completion24 Apr 2022
- Study completion24 Jun 2022
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 University Hospital, Strasbourg, 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 5,694 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05652582
- Sponsor's protocol ID
- 8253
- Acronym
- SeroPrevHUS
- Status last verified
- Dec 2023
- First submitted
- 13 Dec 2022
- Last updated
- 11 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Seroprevalence of SARS-CoV 2 in the Staff of the University Hospitals of Strasbourg
- ClinicalTrials.gov ID
- NCT05652582
- Acronym / sponsor ID
- SeroPrevHUS / 8253
- Conditions
- COVID-19
- Keywords
- COVID-19, SARS-COV-2, Prevalence of SARS-CoV-2
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5,694 participants (actual)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 24 Jun 2021 (actual)
- Primary completion
- 24 Apr 2022 (actual)
- Study completion
- 24 Jun 2022 (actual)
- First posted
- 15 Dec 2022 (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 Grand Est region is one of the most affected regions in France during the first wave of the COVID-19 epidemic. A significant increase in the number of patients hospitalized for SARS-CoV 2 infection at the University Hospitals of Strasbourg (HUS) led to a sudden saturation of their capacities. Hospital workers appear to be a population at particular risk for this new infectious agent. The percentage of hospital workers who have been in contact with the virus or have contracted COVID-19 is unknown.
The objective of this work is to determine the prevalence of SARS-CoV-2 positive serologies among hospital staff screened from June 22, 2020 to November 1, 2020 following a screening campaign offering serological testing to all volunteer HUS professionals.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Hospital staff practicing at HUS who performed SARS-CoV 2 serology in the period from 06/22/2020 to 11/1/2020
Key inclusion criteria (2 listed)
- Adult subject (≥ 18 years of age)
- Hospital staff practicing at HUS who performed SARS-CoV 2 serology in the period from 06/22/2020 to 11/1/2020
Key exclusion criteria (1 listed)
- Subject not meeting inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To determine the positive seroprevalence of SARS-CoV-2 among hospital staff screened from June 22, 2020 to November 1, 2020
Time frame: Files analysed retrospectively from June 22, 2020 to November 1, 2020 will be examined
Seroprevalence will be estimated by calculating the rate of seropositive subjects with its 95% confidence interval
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 11 Dec 2023.
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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, run by University Hospital, Strasbourg, 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 2 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 11 Dec 2023. 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?
To determine the positive seroprevalence of SARS-CoV-2 among hospital staff screened from June 22, 2020 to November 1, 2020 (time frame: Files analysed retrospectively from June 22, 2020 to November 1, 2020 will be examined). 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 11 Dec 2023.