Establishment of a Biological Collection During COVID-19 Serological Screening in APHP Professionals (COVID-HOP)

COVID-19 Clinical Trial

— COVID-HOP  

Official title:

Identification of Markers Associated With the Risk of COVID-19 Infection and Symptomatic COVID+ Versus Asymptomatic COVID+ Status Through the Establishment of a Biological Collection During Serological Screening in APHP Professionals

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04418375
• Other study ID #: APHP200609
• Secondary ID: APHP2006092020-A
• Status: Completed
• Start date: June 8, 2020
• Est. completion date: October 8, 2022

Study information

• Verified date: May 2024
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The objective of the COVID-HOP study is to identify biological and non-biological markers associated to: a positive or negative serology anti SRAS-Cov-2; a positive serology and having presented symptoms or, on the contrary, not having had symptoms; the persistence of immunity or the loss of this immunity over time; the protective nature of the presence of anti SRAS-Cov-2 antibodies.

To answer these questions, a biological collection (serum, plasma, DNA, RNA, mono-nucleated cells and urine) and a collection of detailed clinical data during the serological screening for SARS-CoV-2 of hospital agents (medical and non-medical staff) of the Assistance Publique Hôpitaux de Paris (Paris, France) will be carried out. 4000 professionals in 5 hospitals will be included. As part of the research, the anti SRAS-CoV-2 serology will be monitored 6 months and 12 months after the initial serology. Numerous studies will be carried out from this biological collection and from the database to answer the primary and secondary endpoints.

Description:

To answer the questions raised in the primary and secondary endpoints, a biological collection (serum, plasma, DNA, RNA, mono-nucleated cells and urine) and a collection of detailed data by the mean of a questionnaire (demographic, clinical, lifestyle, professional exposure to the virus, COVID-19 infection with detailed symptoms and complications) during the serological screening for SARS-CoV-2 of hospital agents (medical and non-medical staff) of the Assistance Publique Hôpitaux de Paris (Paris, France) will be carried out. 4000 professionals in 5 hospitals of the Assistance Publique Hôpitaux de Paris. As part of the research, the anti SRAS-CoV-2 serology will be monitored 6 months (M6) and 12 months (M12) after the initial serology and a brief questionnaire (update regarding treatments, co-morbidities, and COVID-19 infection) will be fulfilled at these two time points. Of note, if the inclusion could not be performed during the initial serological screening, the professional will be recalled to be included at M6.

Statistical analysis: The analysis of the determinants independently associated with symptomatic COVID + status will be carried out by uni- and multivariate logistic regression. The internal validation will be carried out by methods of draw with discount (bootstrap). The performance of the model will include calibration (graphical method) and discrimination (AUC). The biomarker study will include the study of the association with COVID + symptomatic versus asymptomatic status by univariate then multivariate analyzes (logistic regression) including clinical variables. The additional value of biomarkers will be studied by comparing the discriminating power of clinical models with and without the new biomarker. Finally, the study of the heterogeneity of COVID + symptomatic and asymptomatic patients will be carried out by an unsupervised analysis of Machine Learning known as archetypes.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1200
• Est. completion date: October 8, 2022
• Est. primary completion date: October 8, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Hospital staff (medical and non-medical)

• Age greater than or equal to 18 years

• Benefiting from or having benefited 6 months ago from carrying out a SARS-CoV-2 serology by venous sampling on a APHP site as part of monitoring by a screening center

• Having been informed about the study and having given their informed consent to participate in the study

• Beneficiary or entitled to a social security scheme

Exclusion Criteria:

• Refusal to participate in the study

• Previously known anemia with hemoglobin <10 g / dL

• Subject already included in a cohort study with biological collection COVID-19

• Exclusion period for subjects included or having been included in a COVID-19 interventional study (prophylactic or curative) or other clinical study

• Subject who received blinded treatment for SARS-Cov-2 in a clinical study

• Recent COVID-19 compatible infection with D0 of symptoms less than 4 weeks before collection

• Subject subject to a judicial protection measure

• Subject under guardianship or curatorship

• Subject under state medical aid

Related Conditions & MeSH terms

• COVID-19

Locations

Country	Name	City	State
France	HEGP	Paris

Sponsors (3)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris	Fondation Hôpitaux de Paris-Hôpitaux de France, Fondation Université de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Identification of markers associated with asymptomatic COVID + status (results of the serological test) versus symptomatic COVID + status through a questionnaire (medical history, work environment, lifestyle) and a biological collection		12 months
Secondary	Identification of markers associated with a positive or a negative serology through a questionnaire (medical history, work environment, lifestyle) and a biological collection		12 months
Secondary	Description of the serological status according to the professional risk of exposure to the virus	The level of risk of occupational exposure to SARS-CoV-2 will be described in detailed (type of activity during the COVID-19 pandemic, type of protection during this activity...)	12 months
Secondary	Description of the clinical manifestations of COVID-19 infection in hospital professionals	All the potential clinical signs of a COVID-19 infection and its complication will be recorded	12 months
Secondary	Identification of risk factors associated with the loss of anti SARS-CoV-2 immunity through a questionnaire (medical history, work environment, lifestyle) and a biological collection		12 months
Secondary	Identification of markers associated with symptomatic COVID-19 infection during follow-up despite the presence of anti SARS-CoV-2 antibodies through a questionnaire (medical history, work environment, lifestyle) and a biological collection		12 months
Secondary	Correlation between the serology result and the PCR result (swabs) for people who have been tested as part of routine care.	Correlation between the serology result and the PCR result (swabs) for people who have been tested by PCR as part of routine care.	12 months
Secondary	Identification of potential therapeutic targets to avoid developing a symptomatic form	purpose of potential ancillary studies using the biological collection	Through study completion, an average of 2 years
Secondary	Identification of potential therapeutic targets to promote the maintenance of an anti SARS-CoV2 protective immunity	purpose of potential ancillary studies using the biological collection	Through study completion, an average of 2 years
Secondary	Creation of COVIDneg and COVID + asymptomatic control groups for other COVID-19 biological collections.	purpose of the biological collection that will include people with a negative SRAS-CoV-2 serology and asymptomatic people with a positive SRAS-CoV-2 serology	Through study completion, an average of 2 years