To test the hypotheses that patients who show severe fatigue after COVID-19 infection exhibit an exaggerated abnormal expression of inflammatory monocyte genes (particularly of the genes involved in pyroptosis, such as IL-1 and IL-6) as compared to…
ID
Source
Brief title
Condition
- Immune disorders NEC
- Respiratory tract infections
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Gene expression profiles and inflammaging in monocytes of fatigued versus
non-fatigued post-COVID patients
Secondary outcome
In fatigued versus non-fatigued post-COVID-19 patients
Cellular immune parameters
- Extensive immunophenotyping of monocyte maturation subsets
- Extensive immunophenotyping of T-lymphocyte maturation subsets, including
recently thymic emigrants
- SARS-CoV2-specific CD8+ T-cell responses using immunodominant SARS-CoV-2
peptides
Molecular parameters
Next generation sequencing of the T-cell receptor repertoire
Background summary
A large proportion of patients suffer from considerable fatigue in the
aftermath of COVID-19 infection.
Recent research in immuno-psychiatry indicates that such fatigue is associated
with (and probably partially caused by) a premature senescent state of the
immune system. This state is characterized by various T cell defects (low
output of naive T cells from the thymus, high levels of terminally
differentiated and exhausted T cells) and by *inflammaging* (high expression of
inflammatory genes in monocytes, high levels of pro-inflammatory cytokines in
the circulation). It is likely that the COVID-19 infection induces such
premature immune-senescent state with chronic low grade inflammation in
vulnerable individuals.
Study objective
To test the hypotheses that patients who show severe fatigue after COVID-19
infection exhibit an exaggerated abnormal expression of inflammatory monocyte
genes (particularly of the genes involved in pyroptosis, such as IL-1 and IL-6)
as compared to unaffected post-Covid-19 patients.
Study design
A: comparative, non-randomized, observational, study
B: Observational cohort
For this study extra Na-Heparin blood (30-35 ml) will be obtained from patients
at 3 and 6 months after discharge at the post-COVID outpatient department, and
from adult healthy controls. Heparin blood will be used for different types of
cellular and molecular analysis.
Study burden and risks
Participants do not benefit, risks are negligible, burden is low.
Wytemaweg 80
Rotterdam 3015 CN
NL
Wytemaweg 80
Rotterdam 3015 CN
NL
Listed location countries
Age
Inclusion criteria
• Post COVID-19 diagnosis (based on positive PCR or multidisciplinary team
decision based on symptoms and CT or positive serology)
• Referred for outpatient follow-up
• Age >= 18 years
• Provided written informed consent
Exclusion criteria
• Unable or not willing to provide written informed consent
• Unable to complete written questionnaires in Dutch
• Living in a nursing home because of a diagnosis of dementia
• Patients that visit the outpatient clinic in another hospital outside of the
region
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 | NL75781.078.20 |