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| ID | Type | Description | Link |
|---|---|---|---|
| APHP200609 | Other Identifier | Assistance Publique - Hôpitaux de Paris | |
| 2020-A01364-35 | Other Identifier | IDRCB |
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| Name | Class |
|---|---|
| Fondation Université de Paris | UNKNOWN |
| Fondation Hôpitaux de Paris-Hôpitaux de France | UNKNOWN |
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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.
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.
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| Measure | Description | 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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" .
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HEGP | Paris | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40019017 | Derived | 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. |
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from february 2021 for the primary outcome and as long as samples will be available in the biological collection.
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
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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Serum (12 mL), Plasma (EDTA 12 mL, citrate 7 mL), Peripheral blood mononucleated cells (PBMC), DNA, RNA, Urine
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 |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |