Coronavirus Clinical Trial
— AntiCoV-HBOfficial title:
COVID 19 : Seroprevalence Study of Anti SRAS-CoV-2 Antibodies in GHT Employees in Haute Bretagne
Verified date | May 2023 |
Source | Rennes University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Since the start of this epidemic, numerous clinical and fundamental studies have been conducted to best adapt the individual management of COVID-19 cases [1-6]. In parallel with this work, it is necessary to better understand the characteristics of the epidemic in the general population but also in the population working in healthcare settings more exposed to SARS-CoV-2. Seroprevalence studies are therefore particularly useful in order to understand the collective immunization rate and the factors that can explain this immunization.
Status | Completed |
Enrollment | 9453 |
Est. completion date | October 12, 2020 |
Est. primary completion date | July 10, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Employees of voluntary establishments of GHT Haute-Bretagne - Employees over the age of 18 - Having signed a free, informed and written consent. Exclusion Criteria: - Employees subject to legal protection (safeguard of justice, guardianship, curatorship) |
Country | Name | City | State |
---|---|---|---|
France | Centre Hospitalier de Fougeres | Fougères | |
France | Centre Hospitalier Grand Fougeray | Grand-Fougeray | |
France | Centre Hospitalier de La Roche Aux Fees | Janzé | |
France | CENTRE HOSPITALIER de VITRE_ Saint Jean (La Guerche) | La Guerche de Bretagne | La Guerche-de-Bretagne |
France | Centre Hospitalier Montfort-Sur-Meu | Montfort sur Meu | |
France | Centre Hospitalier de Redon Carentoir | Redon | |
France | Chu Rennes | Rennes | |
France | Centre Hospitalier St Meen Le Grand | Saint-Méen-le-Grand | |
France | CENTRE HOSPITALIER VITRE_Simone Veil | Vitré |
Lead Sponsor | Collaborator |
---|---|
Rennes University Hospital | Fonds NOMINOE |
France,
Garlantezec R, Heslan C, Tadie E, Tattevin P, Thibault V, Paris C. A lateral flow immunoassay test performance in SARS-CoV-2 seroprevalence surveys: a validation study among healthcare workers. Emerg Microbes Infect. 2020 Dec;9(1):2547-2549. doi: 10.1080/ — View Citation
Garlantezec R, Tadie E, Heslan C, Gary-Bobo P, Oumari S, Saade A, Sitruk A, Tattevin P, Thibault V, Paris C; AntiCOV-HB* working group. SARS-CoV-2 seroprevalence and antibodies persistence among health care workers after the first COVID-19 wave in nine ho — View Citation
Paris C, Tadie E, Heslan C, Gary-Bobo P, Oumari S, Saade A, Sitruk A, Wild P, Thibault V, Tattevin P, Garlantezec R. Risk factors for SARS-CoV-2 infection among health care workers. Am J Infect Control. 2022 Apr;50(4):375-382. doi: 10.1016/j.ajic.2021.11. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | rate of presence of anti-SARS-CoV-2 antibodies (Ig G _ Ig M) among employees working in a GHT Haute Bretagne health establishment. | Rate of presence | at inclusion visit | |
Secondary | a) Validation of the Biotech NG test: | Sensitivity | at inclusion visit | |
Secondary | a) Validation of the Biotech NG test: | Specificity | at inclusion visit | |
Secondary | a) Validation of the Biotech NG test: Agreement between observers (kappa coefficient) for IgG | agreement between observers (kappa coefficient) | at inclusion visit | |
Secondary | a) Validation of the Biotech NG test: Agreement between observers (kappa coefficient) for IgM. | agreement between observers (kappa coefficient) | at inclusion visit | |
Secondary | b) Risk of presence of anti SARS-CoV-2 antibodies in function: | Demographic characteristics (age, sex) | At inclusion visit | |
Secondary | b) Risk of presence of anti SARS-CoV-2 antibodies in function: | - Professional characteristics (establishment, profession, service). | At inclusion visit | |
Secondary | b) Risk of presence of anti SARS-CoV-2 antibodies in function: | - Management of confirmed or probable COVID-19 patients | At inclusion visit | |
Secondary | b) Risk of presence of anti SARS-CoV-2 antibodies in function: | - From contact with confirmed or probable COVID-19 professionals. | At inclusion visit | |
Secondary | b) Risk of presence of anti SARS-CoV-2 antibodies in function: | - From contact in his personal circle with COVID-19 confirmed or probable persons. | At inclusion visit | |
Secondary | b) Risk of presence of anti SARS-CoV-2 antibodies in function: | - Episodes of symptoms suggestive of COVID-19 | At inclusion visit | |
Secondary | b) Risk of presence of anti SARS-CoV-2 antibodies in function: | - The existence of a chronic immunomodulatory pathology | At inclusion visit | |
Secondary | b) Risk of presence of anti SARS-CoV-2 antibodies in function: | - The existence of smoking | At inclusion visit | |
Secondary | c) Risk of presence of anti SARS-CoV-2 antibodies in function: | - The use of materials adapted to good hygiene practices | At inclusion visit | |
Secondary | c) Risk of presence of anti SARS-CoV-2 antibodies in function: | - Service organization | At inclusion visit | |
Secondary | d) Description of the experience and behavioral changes related to the epidemic, | depending on the work sector (COVID dedicated or not) and depending on the profession:
- Rate of employees who changed their tobacco consumption |
at Day 0 | |
Secondary | d) Description of the experience and behavioral changes related to the epidemic, | depending on the work sector (COVID dedicated or not) and depending on the profession:
- Description of the reasons for modifying tobacco consumption |
at Day 0 | |
Secondary | d) Description of the experience and behavioral changes related to the epidemic, | depending on the work sector (COVID dedicated or not) and depending on the profession:
- Rate of employees who changed their alcohol consumption |
at Day 0 | |
Secondary | d) Description of the experience and behavioral changes related to the epidemic, | depending on the work sector (COVID dedicated or not) and depending on the profession:
- Description of the reasons for modification of alcohol consumption |
at Day 0 | |
Secondary | d) Description of the experience and behavioral changes related to the epidemic, | depending on the work sector (COVID dedicated or not) and depending on the profession:
- Rate of employees who have changed their eating habits |
at Day 0 | |
Secondary | d) Description of the experience and behavioral changes related to the epidemic, | depending on the work sector (COVID dedicated or not) and depending on the profession:
- Description of sleep changes |
at Day 0 | |
Secondary | d) Description of the experience and behavioral changes related to the epidemic, | depending on the work sector (COVID dedicated or not) and depending on the profession:
- Description of lived experience and perceived stress |
at Day 0 | |
Secondary | e) Evolution of seroprevalence over time: | For employees identified as COVID "certain or probable"
* Percentage of employees with antibodies (IgG and IgM) against SARS CoV-2 on D30 and D90. |
At Day30 | |
Secondary | e) Evolution of seroprevalence over time: | For employees identified as COVID "certain or probable"
* Evolution of the kinetics of antibodies (IgG and IgM) against SARS CoV-2 on D30 and D90. |
At Day 90 | |
Secondary | e) Evolution of seroprevalence over time: | For the random sample of employees with follow-up on D90: Percentage of employees with antibodies (IgG and IgM) against SARS CoV-2 | At Day 90 |
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