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

NCT04418375 | Completed

• 2 other identifiers: APHP2006092020-A01364-35
• Study Type: observational
• Target: 1,200
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19

Keywords

Serology,; Immunity; Hospital staff; Biobank

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• 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

• Description of the serological status according to the professional risk of exposure to the virus

  12 months

• Description of the clinical manifestations of COVID-19 infection in hospital professionals

  12 months

• 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

• 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Hospital staff agent (medical and non medical) from the "Assistance Publique Hôpitaux de Paris" undergoing a serology to depict IgG anti SRAS-Cov-2 antibodies in a screening center from the "Assistance Publique Hôpitaux de Paris" .

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• Fondation Université de Paris: collaborator
• Fondation Hôpitaux de Paris-Hôpitaux de France: collaborator

Study Sites (1)

HEGP

Paris, France

Location

Related Publications (1)

• 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.

  PMID: 40019017 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Serum (12 mL), Plasma (EDTA 12 mL, citrate 7 mL), Peripheral blood mononucleated cells (PBMC), DNA, RNA, Urine

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Nathalie Dr DEMORY, PhD

  AP-HP, Hôpital Européen Georges Pompidou, Paris

  PRINCIPAL INVESTIGATOR

• Solen Dr KERNEIS, PhD

  AP-HP, Hôpital Cochin, Paris

  PRINCIPAL INVESTIGATOR

• Martine Dr LOUET, PhD

  AP-HP, Hôpital la Pitié Salpêtrière, Paris

  PRINCIPAL INVESTIGATOR

• Bénédicte Dr SAWICKI, PhD

  AP-HP, Hôpital Bichat, Paris

  PRINCIPAL INVESTIGATOR

• Véronique Dr MAHE, PhD

  AP-HP, Hôpital Lariboisière, Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2020
• First Posted: June 5, 2020
• Study Start: June 8, 2020
• Primary Completion: October 8, 2022
• Study Completion: October 8, 2022
• Last Updated: May 3, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: from february 2021 for the primary outcome and as long as samples will be available in the biological collection.
• Access Criteria: Ancillary studies willing to use the biological collection and/or dataset of the COVID-HOP study will be submitted to the scientific board of COVID-HOP for evaluation. Data sharing must be accepted by the sponsor and the PI based on scientific project and scientific involvement of the PI team. Teams wishing obtain IPD must meet the sponsor and IP team to present scientifics (and commercial) purpose, IPD needed, format of data transmission, and timeframe. Technical feasibility and financial support will be discussed before mandatory contractualization

Locations

FR (1)