COVID-19COVID-HOPNCT04418375
Establishment of a Biological Collection During COVID-19 Serological Screening in APHP Professionals (COVID-HOP)
An observational study of COVID-19, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- COVID-19
- How many people
- 1,200 participants
- Where
- 1 siteFrance
- Study dates
- 8 Jun 2020to 8 Oct 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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" .
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Subject subject to a judicial protection measure
- Subject under guardianship or curatorship
- Subject under state medical aid
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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
- Keywords
- Serology,, Immunity, Hospital staff, Biobank
- Medical subject headings
- COVID-19
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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...)
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 12 months
Identification of potential therapeutic targets to avoid developing a symptomatic form
purpose of potential ancillary studies using the biological collection
Measured: 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
Measured: 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
Measured: Through study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2020
- Study start8 Jun 2020
- Primary completion8 Oct 2022
- Study completion8 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Fondation Université de Paris, Fondation Hôpitaux de Paris-Hôpitaux de France
- Responsible party
- Sponsor
- Investigators
- Nathalie Dr DEMORY, PhD, Principal investigator, AP-HP, Hôpital Européen Georges Pompidou, ParisSolen Dr KERNEIS, PhD, Principal investigator, AP-HP, Hôpital Cochin, ParisMartine Dr LOUET, PhD, Principal investigator, AP-HP, Hôpital la Pitié Salpêtrière, ParisBénédicte Dr SAWICKI, PhD, Principal investigator, AP-HP, Hôpital Bichat, ParisVéronique Dr MAHE, PhD, Principal investigator, AP-HP, Hôpital Lariboisière, Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04418375
- Sponsor's protocol ID
- APHP200609
- Other IDs
- APHP200609, 2020-A01364-35
- Acronym
- COVID-HOP
- Status last verified
- May 2024
- First submitted
- 2 Jun 2020
- Last updated
- 3 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
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.
PubMed 40019017
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04418375
- Acronym / sponsor ID
- COVID-HOP / APHP200609
- Conditions
- COVID-19
- Keywords
- Serology,, Immunity, Hospital staff, Biobank
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,200 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Fondation Université de Paris, Fondation Hôpitaux de Paris-Hôpitaux de France
- Study start
- 8 Jun 2020 (actual)
- Primary completion
- 8 Oct 2022 (actual)
- Study completion
- 8 Oct 2022 (actual)
- First posted
- 5 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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" .
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Time frame: 12 months
9 secondary outcomes
Identification of markers associated with a positive or a negative serology through a questionnaire (medical history, work environment, lifestyle) and a biological collection
Time frame: 12 months
Description of the serological status according to the professional risk of exposure to the virus
Time frame: 12 months
Description of the clinical manifestations of COVID-19 infection in hospital professionals
Time frame: 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
Time frame: 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
Time frame: 12 months
Correlation between the serology result and the PCR result (swabs) for people who have been tested as part of routine care.
Time frame: 12 months
Identification of potential therapeutic targets to avoid developing a symptomatic form
Time frame: Through study completion, an average of 2 years
Identification of potential therapeutic targets to promote the maintenance of an anti SARS-CoV2 protective immunity
Time frame: Through study completion, an average of 2 years
Creation of COVIDneg and COVID + asymptomatic control groups for other COVID-19 biological collections.
Time frame: Through study completion, an average of 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2024.
- Derived from this study: PubMed 40019017Smadja 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.
- Individual participant dataSharing planned: Yes
Related trials for COVID-19
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nathalie Dr DEMORY, PhD principal investigator
AP-HP, Hôpital Européen Georges Pompidou, Paris
Solen Dr KERNEIS, PhD principal investigator
AP-HP, Hôpital Cochin, Paris
Martine Dr LOUET, PhD principal investigator
AP-HP, Hôpital la Pitié Salpêtrière, Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04418375, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2024.