An interventional study of Blood sample in Covid19, sponsored by Assistance Publique Hopitaux De Marseille. Status unknown at 1 site in France. Per ClinicalTrials.gov, last updated 2021-08-19.
Sponsored by Assistance Publique Hopitaux De Marseille · Not applicable, Interventional, and Screening
To measure the immunization rate (seroneutralization) in a population of exposed hospital workers (nursing staff assigned to dedicated COVID-19 care units, laboratory staff handling COVID-19 samples).
Current studies on seroconversion and the time course of immunity following exposure to SARS-CoV-2 do not document: i) Seroconversion in populations in repeated and frequent contact with patients; ii) The temporal dynamics of seroconversion at medium term. These two elements are however fundamental in the comprehension and management of this epidemic or of its potential resurgence in the following months and years.
Objective: To measure the immunization rate (seroneutralization) in a population of exposed hospital workers (nursing staff assigned to dedicated COVID-19 care units, laboratory staff handling COVID-19 samples).
Secondary objectives:
Perspectives
7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.
This study's planned enrollment of 1,000 is above the median of 100 across 4,099 interventional studies indexed under COVID-19.
Browse COVID-19 studies →Assistance Publique Hopitaux De Marseille is the lead sponsor of 686 studies on the registry; 148 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Cohort of exposed hospital workers
Cohort of 'unexposed' hospital workers
Exclusion Criteria:
Hospital health care or non-health care staff willing to participate in the study: * Healthcare personnel (physician, nurse, caregiver) who have worked for a minimum of 2 weeks since March 1, 2020 in a care unit dedicated to the management of patients confirmed or suspected of COVID-19 infection, in the participating centers: intensive care units, emergency rooms, radiology, COVID-19 units; * Staff (physician, technician) who have worked for a minimum of 2 weeks since March 1, 2020 in the AP-HM laboratories handling samples from patients confirmed or suspected of having COVID-19 infection.
Other: Blood sample
Hospital health care worker (physician, nurse, caregiver) willing to participate in the study who has not worked since March 1, 2020 in an intensive care unit or emergency department or other department dedicated to the management of patients confirmed or suspected of having COVID-19 infection.
Other: Blood sample
Seroneutralization and Elisa tests
To establish the level of immunization (seroprevalence) to COVID-19 as determined by the seroneutralization test in a population of exposed hospital workers
Positive seroneutralization test result: the threshold of positivity is set at 40, i.e. any serum with a seroneutralizing value greater than or equal to 40 will be considered positive.
Time frame: 4, 8 and 12 months follow-up visits after the initial visit
Kinetics of the protective antibody immune response (protective immunization against SARS-CoV-2 COVID-19) in a population of exposed hospital workers over a 12-month period.
The kinetics of "seroprevalence" will be defined by the results of the seroneutralization test at 4 time-points (4, 8 and 12 month follow-up visits after the initial visit).
Time frame: 4, 8 and 12 months follow-up visits after the initial visit
Compare immunization profiles
Combine multiple measurement in order to compare immunization profiles (symptomatic status,individual characteristics, i.e, gender, age range, condition of lockdown, blood type; professional characteristics and possible clinical signs.
Time frame: 12 months after the initial visit
Compare the seroprevalence of SARS-CoV-2 and the kinetics of immunization between two groups (exposed hospital workers and a less exposed hospital workers).
Compare between groups the results of the seroneutralization test over time.
Time frame: 4, 8 and 12 months follow-up visits after the initial visit
Identify the technical (sensitivity and specificity) and predictive (positive and negative predictive values) characteristics of the ELISA test evaluated in comparison with the reference test (serum neutralization) in the population of interest.
ELISA's test positivity will be defined with reference to the manufacturer's recommendations. For a ratio OD of the tested sample / kit control: * \<0.9: negative test * Between 0.9 and 1.1: unspecified test * \>1.1: positive test The result will be processed under two modalities: negative/indeterminate/positive and quantitative
Time frame: 12 months
Record COVID-19 seroprevalences established by ELISA at different time points: inclusion, 4 months, 8 months, and 12 months after inclusion.
The technical and predictive characteristics of the ELISA test (sensitivity, specificity, positive predictive value and negative predictive value) are documented by reference to the serum neutralisation test.
Time frame: 4, 8 and 12 months follow-up visits after the initial visit
This study is status unknown, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Assistance Publique Hopitaux De Marseille