Objective: To evaluate the humoral response and estimate the prevalence of antibodies against SARS-CoV2 in children during the COVID-19 outbreak in the Netherlands.
ID
Source
Brief title
Condition
- Viral infectious disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Main study parameters/endpoints: IgG, IgM, IgA and total neutralizing
antibodies against SARS-CoV2 in blood and secretory IgA levels against
SARS-CoV2 in saliva from all participants
Secondary outcome
na
Background summary
Rationale: Coronavirus disease 2019 (COVID-19) first started in China in
December 2019 and the outbreak was declared a pandemic by the World Health
Organization (WHO) on 11 March 2020. Sero-epidemiological studies can identify
patients that have been infected with SARS-CoV2, regardless of the severity of
their illness. These studies are needed to provide estimates of herd immunity
that are essential for public health policy makers. The antibody response is
crucial for preventing viral infections and may also contribute to combat
infection. The first seroepidemiological studies in adults in the Netherlands
are being initiated, but there is currently no data on immunity in children.
Evidence is emerging that while children suffer less severely from COVID-19,
they do get infected, can spread the virus, and elicit IgG, IgM, IgA or
secretory IgA responses. Differences in the humoral response to SARS-CoV2 in
between children and adults may partly explain the difference in disease
severity.
Objective: To evaluate the humoral response and estimate the prevalence of
antibodies against SARS-CoV2 in children during the COVID-19 outbreak in the
Netherlands.
Study objective
Objective: To evaluate the humoral response and estimate the prevalence of
antibodies against SARS-CoV2 in children during the COVID-19 outbreak in the
Netherlands.
Study design
Study design: Multicenter prospective cohort study,
Study burden and risks
Nature and extent of the burden and risks associated with participation,
benefit and group relatedness:
This study is classified as an observational study in subjects under 18 years
of age. We will ask additional blood to be collected if the patient has blood
tests ordered by the treating physician in routine medical care. The child will
not be subjected to additional dermal or vena punctures for this study. Blood
can be obtained when the child presents to the emergency department, during
hospitalization, or in the outpatient clinic of the participating hospitals. We
will ask for an additional 1 ml of blood in children aged 0-1 years, 2 ml in
1-5 year olds, and 5 ml in 5-18 year olds. Simultaneously, a saliva sample with
a buccal swab will be sampled. The burden to participate in this study is
therefore negligible. Parents/guardians can join their child at all times
during the procedure.
The individual study results will be shared with the parents/guardians after
finalizing the study.
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
All children younger than 18 years of age that have blood drawn for
normal/standard medical care in the emergency room, hospital ward or outpatient
clinic of a participating hospital
Exclusion criteria
No written informed consent from parents/ guardians or eligible child older
than 12 years of age.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL73556.018.20 |
| OMON | NL-OMON27267 |