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

NCT ID: NCT04418375

Last Updated: 2024-05-03

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-06-08
• Study Completion Date: 2022-10-08

Brief 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.

Detailed 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.

Conditions

COVID-19

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Fondation Université de Paris

UNKNOWN

Sponsor Role: collaborator

Fondation Hôpitaux de Paris-Hôpitaux de France

UNKNOWN

Sponsor Role: collaborator

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nathalie Dr DEMORY, PhD

Role: PRINCIPAL_INVESTIGATOR

AP-HP, Hôpital Européen Georges Pompidou, Paris

Solen Dr KERNEIS, PhD

Role: PRINCIPAL_INVESTIGATOR

AP-HP, Hôpital Cochin, Paris

Martine Dr LOUET, PhD

Role: PRINCIPAL_INVESTIGATOR

AP-HP, Hôpital la Pitié Salpêtrière, Paris

Bénédicte Dr SAWICKI, PhD

Role: PRINCIPAL_INVESTIGATOR

AP-HP, Hôpital Bichat, Paris

Véronique Dr MAHE, PhD

Role: PRINCIPAL_INVESTIGATOR

AP-HP, Hôpital Lariboisière, Paris

Locations

HEGP

Paris, , France

Countries

France

References

Smadja DM, Roux de Bezieux J, Peronino C, Jilet L, Ivak P, Pya Y, Philippe A, Latremouille C, Gustafsson F, Ramjankhan FZ, Roussel JC, Courbebaisse M, Parfait B, Lebeaux D, Friedlander G, Vincentelli A, Flecher E, Gaussem P, Jansen P, Netuka I. Understanding Platelet Activation in the Aeson Bioprosthetic Total Artificial Heart: Insights From Aspirin Treatment and Outcomes. ASAIO J. 2025 Sep 1;71(9):701-710. doi: 10.1097/MAT.0000000000002403. Epub 2025 Feb 28.

Reference Type: DERIVED

PMID: 40019017 (View on PubMed)

Other Identifiers

APHP200609

Identifier Type: OTHER

Identifier Source: secondary_id

2020-A01364-35

Identifier Type: OTHER

Identifier Source: secondary_id

APHP200609

Identifier Type: -

Identifier Source: org_study_id