The aim of this study is to establish how many employees at Reade have had an infection with SARS-CoV-2, tested with a novel assay for the detection of antibodies against SARS-CoV-2 developed by Sanquin. This study will focus on our own institute,…
ID
Source
Brief title
Condition
- Viral infectious disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary study parameter is the proportion of Reade employees which is
SARS-CoV-2 IgM or IgG positive at baseline and after 6 months of follow-up.
Secondary outcome
The secondary study parameter is the proportion of asymptomatic SARS-CoV-2
positive healthcare professionals.
Background summary
COVID-19 has caused an extensive burden on the healthcare system. The main
reasons for this burden is the sudden increased influx of COVID-19 patients,
outage of healthcare professionals and third probably unnecessary
self-isolation of healthcare professionals. To keep the health institutions and
services up and running we need to better understand the in-hospital
transmission. One way to do that is to start testing healthcare professionals,
preferable in a more sustainable way by serology testing, on their presence of
SARS-CoV-2 IgM or IgG antibodies.
Study objective
The aim of this study is to establish how many employees at Reade have had an
infection with SARS-CoV-2, tested with a novel assay for the detection of
antibodies against SARS-CoV-2 developed by Sanquin. This study will focus on
our own institute, Reade, which is a rheumatology and revalidation centre in
Amsterdam.
Study design
The design of the study is an explorative descriptive study. At two time points
participants are asked to fill out a short questionnaire. Next to that they are
also asked to donate blood at those two time points.
The study is expected to cover approximately 9 months; recruitment and
enrolment will comprise 1 month, follow-up 6 months and analyses 2 months.
Study burden and risks
This is an observational study. The study comprises a questionnaire that does
not probe any *sensitive* topics. The blood test does not probe any sensitive
determinants. During each visit 10 cc blood will be drawn. As such, we have
asked the METC for exemption for insurance which covers compensation for
injury.
Dr. Jan van Bremenstraat 2
Amsterdam 1056 AB
NL
Dr. Jan van Bremenstraat 2
Amsterdam 1056 AB
NL
Listed location countries
Age
Inclusion criteria
* Employed at Reade;
* Age * 18 years.
Exclusion criteria
* Language problems precluding the completion of the questionnaire;
* Lack of informed consent.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL74098.029.20 |