To study the antibody response as a disease modifying factor in the context of COVID-19, we will compare the anti-CoV antibody composition, quality and interaction with immune receptors.
ID
Source
Brief title
Condition
- Autoimmune disorders
- Viral infectious disorders
- Respiratory tract infections
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Fucosylation of SARS-CoV-2 IgG antibodies defined as percentage of
fucose-containing glycans attached to N297 in the IgG-Fc. Focus will be on the
main subclass generated (IgG1 and IgG3).
Secondary outcome
We compare the anti-CoV antibody response and interaction with immune receptors
between cases and controls by:
- Anti-CoV antibody levels, (sub)class and antigen specificity (ELISA)
- Anti-CoV antibody glycosylation
- Interaction of serum-derived patient anti-CoV antibodies with a biosensor
equipped with all human Fc-gamma receptors
- Inflammatory markers of juvenile idiopathic arthritis (see UCAN CAN-DU
protocol)
-To study gene expression profiles to distinguish between inflammatory and
infectious causes of fever.
Background summary
The COVID-19 pandemic caused by SARS-CoV-2, has 24 million confirmed cases and
more than 800.000 deaths. Patient responses to SARS-CoV-2 (COVID-19) are highly
diverse, ranging from asymptomatic or mild self-limiting infection, to a severe
upper airway inflammation leading to respiratory distress, often with a fatal
outcome. This suggests different paths taken by the immune system to combat
the disease, so far there is no clear evidence that can make a distinction
between these two different immunological and pathological paths. It is also
not known how the immune response to COVID in MIS-C compares to other
hyperinflammatory diseases in childhood such as juvenile idiopathic arthritis.
In the recent past, have discovered that antibody responses to enveloped viral
infections can be altered. Posttranslational modification through glycosylation
can either give a protective response or enhance the disease phenotype through
an overreacting immune response. There have been many cases of children and
adolescents with COVID-19-assocated multisystem inflammatory conditions, which
seems to develop after a COVID-19 infection. The multisystem inflammatory
syndrome in children (MIS-C) can lead to shock and multiple organ failure
requiring intensive care. The pathophysiology of MIS-C is still unclear.
Study objective
To study the antibody response as a disease modifying factor in the context of
COVID-19, we will compare the anti-CoV antibody composition, quality and
interaction with immune receptors.
Study design
This is a non-interventional, observational case-control study:
Cases: laboratory-confirmed SARS-CoV-2 infection with MIS-C. We will recruit
retrospective and prospective cases. A single blood draw is taken from
retrospective cases and two blood draws from prospective cases. For the main
analysis all cases will be pooled. Furthermore they will get a short
questionary.
Controls: three control populations will be distinguished in (A) children
suspected of MIS-C but with negative COVID diagnostics, (B) children with
proven acute COVID respiratory infection and (C) otherwise healthy children
prior to elective surgery. A single blood draw prior to surgery is taken from
control group 3 and two blood draws from control group 1 and control group 2.
Furthermore they will get a short questionary.
Study burden and risks
There will be a blood draw, which is the most stressful part.
POB 85090, Kamer KC030630 Lundlaan 6
3508 AB Utrecht Utrecht
NL
POB 85090, Kamer KC030630 Lundlaan 6
3508 AB Utrecht Utrecht
NL
Listed location countries
Age
Inclusion criteria
Children 0-16 years of age with a laboratory confirmed COVID-19 (RIVM) and
MIS-C.
Exclusion criteria
Severe immune-related comorbidity (humoral immunodeficiency, cellular
immunodeficiency, treatment for cancer, treatment with biologicals, IVIG
treatment at moment of inclusion).
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 | NL75633.041.20 |