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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: COVID-19

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.

• Study Type: Observational
• Enrollment (Actual): 1200

Contacts and Locations

Study Locations

• France
  • Paris, France
    • HEGP

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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" .

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborators: Fondation Université de Paris; Fondation Hôpitaux de Paris-Hôpitaux de France
• Investigators: Principal Investigator: 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

Study record dates

Study Major Dates

• Study Start (Actual): June 8, 2020
• Primary Completion (Anticipated): October 1, 2022
• Study Completion (Anticipated): October 1, 2022

Study Registration Dates

• First Submitted: June 2, 2020
• First Submitted That Met QC Criteria: June 4, 2020
• First Posted (Actual): June 5, 2020

Study Record Updates

• Last Update Posted (Actual): May 13, 2022
• Last Update Submitted That Met QC Criteria: May 12, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Biobank; Immunity; Serology,; Hospital staff
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: APHP200609 (Other Identifier: Assistance Publique - Hôpitaux de Paris); 2020-A01364-35 (Other Identifier: IDRCB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Sharing Time Frame: from february 2021 for the primary outcome and as long as samples will be available in the biological collection.

IPD Sharing 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

• IPD Sharing Supporting Information Type: Study Protocol; Informed Consent Form (ICF)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No