To study anti-SARS-CoV-2 antibody-mediated inflammatory responses by macrophages in individuals with obesity.
ID
Source
Brief title
Condition
- Viral infectious disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Measurement of pro-inflammatory cytokines interleukin (IL)-6, IL-1β, and tumor
necrosis factor (TNF) production by macrophages in response to SARS-CoV-2 viral
and antibody costimulation.
Secondary outcome
- Pro-inflammatory cytokine (IL-6, IL-1β, and TNF) production by macrophages
upon separate viral stimulation and antibody stimulation
- Macrophage expression levels of activation markers and Fc-gamma receptors
- Macrophage intracellular lipid content
- Macrophage metabolic profiling
- mRNA expression of proteins of interest in macrophages
- Epigenetic analyses: chromatin accessibility, histone modification, and
transcription/epigenetic factor binding
- Proteomics (profiling of plasma proteins)
- SARS-CoV-2 antigen-specific T cell responses
- SARS-CoV-2 antigen-specific antibodies
- Clinical chemistry and haematology data (only cohort 1)
- Plasma pro-inflammatory cytokine levels
- Additional cytokines and chemokines produced by macrophages upon stimulation
with antibodies
- History of and severity of prior SARS-CoV-2 infections
Background summary
COVID-19 continues to result in hospital admissions and case fatalities
worldwide. Obesity is recognized as a major risk factor for severe COVID-19,
yet the underlying mechanisms remain unclear. Previous studies suggest that
SARS-CoV-2 antibodies may play a pathogenic role by promoting inflammation
through binding to Fc-gamma receptors on alveolar macrophages. However, this
mechanism has not been explored in obese individuals. A better understanding of
COVID-19 pathophysiology in obese patients could lead to new therapeutic
approaches, potentially beneficial for future coronaviruses that cause similar
diseases.
Study objective
To study anti-SARS-CoV-2 antibody-mediated inflammatory responses by
macrophages in individuals with obesity.
Study design
Prospective observational cohort study
Study burden and risks
This study aims to significantly advance our understanding of COVID-19
pathophysiology in obese patients, contributing to the broader scientific
knowledge and potentially informing improved treatment and management
strategies for COVID-19. These findings may ultimately benefit both individual
patients and society at large. The primary risk to participants is associated
with the single venipuncture, which may cause temporary discomfort or pain and
carries a minor risk of hematoma formation.
Kleiweg 500
Rotterdam 3045PM
NL
Kleiweg 500
Rotterdam 3045PM
NL
Listed location countries
Age
Inclusion criteria
Cohort 1 (obesity cohort)
- >=18 and <=65 years of age
- BMI >=30 kg/m2
- Patient of Franciscus Hospital
Cohort 2 (control cohort)
- >=18 and <=65 years of age
- BMI <25 kg/m2
- Healthcare workers of Franciscus Hospital
Exclusion criteria
Cohort 1 and 2 (obesity cohort and control cohort)
- Acute infection or current systemic immunological disorders
- Use of immune-modulatory medication (i.e., corticosteroids and biologicals)
- Hormonal therapy
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 | NL88800.100.25 |