Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05766111 |
| Other study ID # |
3253 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
June 1, 2020 |
| Est. completion date |
July 1, 2020 |
Study information
| Verified date |
March 2023 |
| Source |
Fondazione Policlinico Universitario Agostino Gemelli IRCCS |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical Trial 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 limited/no
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 nasal/oropharyngeal swabs as the diagnostic gold standard.
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 nurses.Medical 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 (i.e.,
a Ct less than 40) for at least one of two viral targets (i.e., 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 Pearson's 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.
