Primary objective* To determine the seroprevalence of SARS-CoV-2 neutralising antibodies in HCWs in Dutch hospitals.Secondary objectivesBaseline, all participants * To determine the seroprevalence of SARS-CoV-2 total antibodies in HCWs in Dutch…
ID
Source
Brief title
Condition
- Viral infectious disorders
- Respiratory tract infections
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Main study endpoint
* Seroprevalence of SARS-CoV-2 neutralising antibodies.
Secondary outcome
Secondary study endpoints
* Seroprevalence of SARS-CoV-2 total antibodies.
* SARS-CoV-2 serum neutralisation titer (serum).
* SARS-CoV-2 sqRT-PCR cycling threshold (Ct) value (nasopharyngeal/throat swab).
* Median tissue culture infectious dose (TCID50) (nasopharyngeal/throat swab).
* Cumulative incidence of seroconversion for SARS-CoV-2 (neutralising)
antibodies.
* Cumulative incidence of sqRT-PCR- and/or virus culture-confirmed SARS-CoV-2
(re)infection.
* Cumulative incidence of self-reported symptoms suspected for COVID-19.
* Duration (number of days) of self-reported symptoms suspected for COVID-19.
* Duration (number of days) of (unplanned) absenteeism.
* Duration (number of days) of (unplanned) absenteeism because of documented
SARS-CoV-2 infection.
* Duration (number of days) of (unplanned) absenteeism because of self-reported
symptoms suspected for COVID-19.
* Duration (number of days) of (unplanned) absenteeism because of imposed
quarantine for being exposed to SARS-CoV-2 infection.
* Cumulative incidence of hospital admission for any reason.
* Cumulative incidence of hospital admission for documented SARS-CoV-2
infection.
* Duration (number of days) of hospital admission for any reason.
* Duration (number of days) of hospital admission for documented SARS-CoV-2
infection.
* Cumulative incidence of all-cause death.
* Cumulative incidence of death due to documented SARS-CoV-2 infection.
Background summary
Since December 2019, the world has been in the grip of the severe acute
respiratory syndrome coronavirus 2 (SARS-CoV-2) and the disease it causes,
coronavirus disease 2019 (COVID-19). Effective management of this pandemic
requires estimation of the burden of disease. Currently available literature on
COVID-19 mostly represents severe cases admitted to the hospital; data on mild
and unsuspected clinical presentations and asymptomatic infections are largely
unknown. Sero-epidemiologic studies are urgently needed to help uncover the
burden of disease, in particular the rate of asymptomatic infections, and to
get better estimates on the incidence of disease. Sero-epidemiologic studies
can help identify the extent to which the virus has spread and whether this has
led to protective immunity. Such information could help guide infection control
policies. This study will evaluate the sero-epidemiology of SARS-CoV-2 in
healthcare workers (HCWs) in Dutch hospitals.
Study objective
Primary objective
* To determine the seroprevalence of SARS-CoV-2 neutralising antibodies in HCWs
in Dutch hospitals.
Secondary objectives
Baseline, all participants
* To determine the seroprevalence of SARS-CoV-2 total antibodies in HCWs in
Dutch hospitals in areas with varying incidence of COVID-19 upon enrolment
(baseline).
* To determine if the seroprevalence of SARS-CoV-2 (neutralising) antibodies in
HCWs is related to illness or (unplanned) absenteeism in the four months before
enrolment.
* To determine if the seroprevalence is related to the risk of SARS-CoV-2
exposure
* To describe the clinical presentation of documented SARS-CoV-2 infection in
the four months before enrolment.
Study design
This observational study is designed as a cross-sectional study with
prospective follow-up in HCWs of ten to twelve Dutch university and
non-university hospitals with a representative participation of hospitals from
areas with a high incidence of COVID-19 . The duration of follow-up will be
three months after enrolment. Follow-up of symptoms that started within these
three months will be followed-up until symptom resolution. The study will end
after the last follow-up period has ended for the last subject.
Study burden and risks
Participation in this observational study poses a negligible risk and the
burden is considered minimal. Subjects will have a 10-mL blood sample drawn on
two occasions if no self-reported symptoms suspected for COVID-19. In case of
self-reported symptoms suspected for COVID-19 during the follow-up, a 10-mL
blood sample and a nasopharyngeal/throat swab will be obtained on three
additional occasions. A retrospective questionnaire will be administered at
enrolment and 12 weekly short questionnaires during follow-up. In case of
self-reported symptoms suspected for COVID-19, a diary on symptoms will be kept
until the resolution of symptoms. Participation in the study will not interfere
with, or influence local infection control policies for HCWs. There is no
direct benefit to subjects, except that individual test results will be made
available to the subject during and after the end of the study.
Heidelberglaan 100
Utrecht 3508 AB
NL
Heidelberglaan 100
Utrecht 3508 AB
NL
Listed location countries
Age
Inclusion criteria
A subject who meets all of the following criteria will be eligible to
participate in this study:
* HCW employed in one of the participating hospitals
Exclusion criteria
A potential subject who meets any of the following criteria will be excluded
from participation in this study:
* Age below 18 years
* Direct involvement in the design or execution of this study
* Expected absence from work for more than four weeks during follow-up
* Legally incapacitated or unwilling to provide 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 | NL73836.041.20 |
| Other | NTR:NL 8528 |