Establishment of a Biological Collection During COVID-19 Serological Screening in APHP Profession… (NCT04418375) | Clinical Trial Compass
CompletedNot Applicable
Establishment of a Biological Collection During COVID-19 Serological Screening in APHP Professionals (COVID-HOP)
France1,200 participantsStarted 2020-06-08
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
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