COVID-19 Respiratory InfectionCoVEREDNCT04893057
COVID-19 Seroprevalence in Pregnant Women and Blood Donors
An observational study of COVID-19 Respiratory Infection, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
Trial summary
The study aims to measure the SARS-CoV-2 seroprevalence (ie. the proportion of people with antibodies against the virus) in pregnant women and blood donors in an administrative area of France, and to determine whether these measures are representative of the general population. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- COVID-19 Respiratory Infection
- How many people
- 797 participants
- Where
- 1 siteFrance
- Study dates
- 15 Sep 2022to 4 Jan 2023
- 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 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adult pregnant women and adult blood donors
Who may be able to join
- Pregnant women
- Adult female
- Admitted to hospital for live birth
- Informed consent
- Affiliated to the French social security health insurance scheme
- Blood donors
Show all 10Show fewer
- Adult male or female
- Qualified for whole blood donation (up to 70 years old in France)
- Informed consent
- Affiliated to the French social security health insurance scheme
Who cannot join
- Legal incapacity or limited legal capacity
- Subject without health insurance coverage
- Exclusion period of another study or exclusion period of the French national healthy volunteer registry
Trial locations and contacts
1 site in 1 country.
About this study
Official title: SARS-CoV-2 sERoprévalences Dans la Population Des Femmes Enceintes et Donneurs de Sang
The study aims to measure the SARS-CoV-2 seroprevalence (ie. the proportion of people with antibodies against the virus) in pregnant women and blood donors in an administrative area of France, and to determine whether these measures are representative of the general population.
- Conditions
- COVID-19 Respiratory Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Pregnant women | Women admitted to hospital for a live birth. | |
| Blood donors | Subjects qualified for whole blood donation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anti-SARS-CoV-2 spike protein total IgG
Total IgG directed against anti-SARS-CoV-2 spike protein as measured by ELISA assay
Measured: at inclusion
Secondary outcomes (1)
Anti-SARS-CoV-2 nucleocapsid protein total IgG
Total IgG directed against anti-SARS-CoV-2 nucleocapsid protein as measured by ELISA assay
Measured: at inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2021
- Study start15 Sep 2022
- Primary completion4 Jan 2023
- Study completion4 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19 Respiratory InfectionStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de BesanconThe 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
- Cross-sectional
- Enrolment
- 797 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maxime Desmarets, MD, PhD, Principal investigator, CHU Besançon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04893057
- Sponsor's protocol ID
- 2021/601
- Acronym
- CoVERED
- Status last verified
- Oct 2024
- First submitted
- 11 May 2021
- Last updated
- 4 Oct 2024
- 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 4 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SARS-CoV-2 sERoprévalences Dans la Population Des Femmes Enceintes et Donneurs de Sang
- ClinicalTrials.gov ID
- NCT04893057
- Acronym / sponsor ID
- CoVERED / 2021/601
- Conditions
- COVID-19 Respiratory Infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 797 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Study start
- 15 Sep 2022 (actual)
- Primary completion
- 4 Jan 2023 (actual)
- Study completion
- 4 Jan 2023 (actual)
- First posted
- 19 May 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 study aims to measure the SARS-CoV-2 seroprevalence (ie. the proportion of people with antibodies against the virus) in pregnant women and blood donors in an administrative area of France, and to determine whether these measures are representative of the general population.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pregnant women | – | –Women admitted to hospital for a live birth. |
| Blood donors | – | –Subjects qualified for whole blood donation |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adult pregnant women and adult blood donors
Key inclusion criteria (10 listed)
- Pregnant women
- Blood donors
Key exclusion criteria (3 listed)
- Legal incapacity or limited legal capacity
- Subject without health insurance coverage
- Exclusion period of another study or exclusion period of the French national healthy volunteer registry
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
Anti-SARS-CoV-2 spike protein total IgG
Time frame: at inclusion
Total IgG directed against anti-SARS-CoV-2 spike protein as measured by ELISA assay
1 secondary outcome
Anti-SARS-CoV-2 nucleocapsid protein total IgG
Time frame: at inclusion
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 Oct 2024.
- 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.
Maxime Desmarets, MD, PhD principal investigator
CHU Besançon
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 Respiratory Infection, run by Centre Hospitalier Universitaire de Besancon 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 10 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: finished, as of the sponsor's last update on 4 Oct 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?
Anti-SARS-CoV-2 spike protein total IgG (time frame: at inclusion). 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 4 Oct 2024.