Ignite Creation Date:
2024-05-06 @ 6:43 PM
Last Modification Date:
2024-10-26 @ 2:53 PM
Study NCT ID:
NCT05766111
Status:
COMPLETED
Last Update Posted:
2023-03-13
First Post:
2023-03-10
Brief Title:
COVID-19 Seroprevalence Among Healthcare Workers of a Large COVID-19 Hospital in Rome
Sponsor:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Organization:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study Overview
Official Title:
Seroprevalence Survey in Healthcare Workers of the A Gemelli IRCCS University Hospital Foundation as Part of the Surveillance and Control Activities of the Covid-19 Epidemic
Status:
COMPLETED
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Healthcare workers are at the forefront against COVID-19 worldwide Since Fondazione Policlinico Universitario A Gemelli FPG IRCCS was enlisted as a COVID-19 hospital the healthcare workers deployed to COVID-19 wards were separated from those with limitedno exposure whereas the administrative staff were designated to work from home Between June and July 2020 an investigation will conduct to evaluate the seroprevalence of severe acute respiratory syndrome coronavirus 2 SARS-CoV-2 immunoglobulin IgG antibodies among the employees of the FPG using point-of-care POC and venous blood tests Sensitivity specificity and predictive values were determined with reverse-transcription polymerase chain reaction on nasaloropharyngeal swabs as the diagnostic gold standard
Detailed Description:
This cross-sectional study will consist of a seroprevalence survey between June 2020 and July 2020 which enroll participants on a voluntary basis via a hospital e-mail system including medical non-medical HCW and administrative staff AS of the FPG The study approved by the FPG ethics committee and participants sign an informed consent form before their inclusion in the study Both the venous blood and POC SARS-CoV-2 serological tests will offer to each participant and perform in dedicated blood-drawing areas in compliance with COVID-19 safety regulations In cases with a positive result from at least one test participants undergo NOS sampling for RT-PCR SARS-CoV-2 RNA detection to assess the actual infection status Unlike the venous blood testing the POC testing will perform by trained clinical staff composed of public health residents and student nursesMedical and non-medical HCWs will categorize into two groups by whether they had or had not assisted COVID-19 patients in the period between 9 March 2020 the date of the first COVID-19 patients in our hospital and 1 June 2020 the date of seroprevalence survey initiation For predictivity analysis which requires the consideration of the prevalence of the studied population we used the AS as a further comparison group because this was a group with low seroprevalence This is because these participants were less exposed to COVID-19 infection than HCWs and many of them had been in work-from-home arrangements for two days a week from 9 March 2020
As mentioned above participants that will test positive for SARS-CoV-2 specific antibodies with at least one of the serological tests used in the study will sample for NOS testing within 48 h after positive serological test results will be available RT-PCR testing on NOS samples will perform using the Seegene Allplex 2019-nCoV assay and a positive result ie a Ct less than 40 for at least one of two viral targets ie RdRP and N genes indicated the presence of SARS-CoV-2 RNA As current studies show marked variation and are likely to overestimate sensitivity we used the lower end of current estimates from systematic reviews with the approximate numbers of 70 for sensitivity and 95 for specificity for illustrative purposes
Descriptive analysis will perform for sex age professional category and wards of the HCWs The difference between proportions will evaluate with the two proportion Z test Seroprevalence will calculate separately for tests on the venous samples and the POC tests Seroprevalence for the tests on the venous samples will estimate as the proportion of individuals who will have a positive result of IgG in the immunoassay Furthermore for the tests on capillary blood seroprevalence for both IgM and IgG will estimete as the proportion of individuals who will have positive results in the corresponding band of the POC test
We also re-estimate the sensitivity and specificity of the POC test using the immunoassay as a reference The accuracy of the capillary versus the venous test will evaluate with sensitivity specificity and predictive values with 95 confidence intervals CIs Each of the seroprevalences will stratify for professional category age and wards in which they worked during the COVID-19 emergency
The difference between positivity in one of the serological tests and positivity in the RT-PCR on NOS samples will estimate through Pearsons chi-squared tests The Spearman rank test Bonferroni-adjusted will use to evaluate the correlation between the anti-SARS-CoV-2 IgG assay in capillary blood versus the same titer in venous blood
As mentioned above participants that will test positive for SARS-CoV-2 specific antibodies with at least one of the serological tests used in the study will sample for NOS testing within 48 h after positive serological test results will be available RT-PCR testing on NOS samples will perform using the Seegene Allplex 2019-nCoV assay and a positive result ie a Ct less than 40 for at least one of two viral targets ie RdRP and N genes indicated the presence of SARS-CoV-2 RNA As current studies show marked variation and are likely to overestimate sensitivity we used the lower end of current estimates from systematic reviews with the approximate numbers of 70 for sensitivity and 95 for specificity for illustrative purposes
Descriptive analysis will perform for sex age professional category and wards of the HCWs The difference between proportions will evaluate with the two proportion Z test Seroprevalence will calculate separately for tests on the venous samples and the POC tests Seroprevalence for the tests on the venous samples will estimate as the proportion of individuals who will have a positive result of IgG in the immunoassay Furthermore for the tests on capillary blood seroprevalence for both IgM and IgG will estimete as the proportion of individuals who will have positive results in the corresponding band of the POC test
We also re-estimate the sensitivity and specificity of the POC test using the immunoassay as a reference The accuracy of the capillary versus the venous test will evaluate with sensitivity specificity and predictive values with 95 confidence intervals CIs Each of the seroprevalences will stratify for professional category age and wards in which they worked during the COVID-19 emergency
The difference between positivity in one of the serological tests and positivity in the RT-PCR on NOS samples will estimate through Pearsons chi-squared tests The Spearman rank test Bonferroni-adjusted will use to evaluate the correlation between the anti-SARS-CoV-2 IgG assay in capillary blood versus the same titer in venous blood
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None