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Deciphering Long-COVID: Uncovering the Significance of Immunological & Virological Dysregulation Underpinning Long-COVID Pathophysiology (DECI-LOCO Study)

Deciphering Long-COVID: Uncovering the Significance of Immunological & Virological Dysregulation Underpinning Long-COVID Pathophysiology (DECI-LOCO Study) - DECI-LOCO study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON56085
Enrollment
120
Registered
2023-09-25
Start date
2023-12-11
Completion date
Unknown
Last updated
2025-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Long-COVID

Interventions

Blood sampling, hair sample, and questionnaires.

Sponsors

Erasmus MC, Universitair Medisch Centrum Rotterdam
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Long-COVID patients • Age >= 18 years, = 18 years, 95% compared to functioning prior COVID-19 infection • Self-reported general good wellbeing • Provided written informed consent

Exclusion criteria

Exclusion criteria: Long-COVID patients • Unable or not willing to provide written informed consent • Unable to complete written questionnaires in Dutch • Unable to draw blood for study purposes • Diagnosis of dementia • Active treatment with hyperbaric oxygen treatment during study start • Alternative diagnosis that may explain clinical symptoms  • No re-infection with COVID-19 in the past 3 months • Suffering from any pre-existing immune-driven disease or use of  anti-inflammatory therapy of any kind (including NSAIDs and steroids) during  the last 3 months • CC • Unable or not willing to provide written informed consent • Unable to complete written questionnaires in Dutch • Unable to draw blood for study purposes • Diagnosis of dementia • Genetically related to participating patients (e.g. brother/sister/parent) • Suffering from any immune-driven disease or use of anti-inflammatory therapy  of any kind (including NSAIDs and steroids), including during the last 3 months • Re-infection with SARS-CoV-2 in the past 3 months before the start of the study • Unable or not willing to provide written informed consent • Unable to complete written questionnaires in Dutch

Design outcomes

Primary

MeasureTime frame
The main study parameter is difference in percentage of age-associated B cells (ABCs) in the circulation of long-COVID patients compared with CCs.

Secondary

MeasureTime frame
Immunological profile    The quantification of ABCs as primary parameter will be part of the immunological profiling of long-COVID patients. This will be accompanied by the characterization and quantification of several other parameters of circulating lymphoid (B and T cell) and myeloid (monocytes and dendritic cells) populations. Frequencies as well as the activation status of different subsets will be determined in PBMCs from both patients and controls. In addition, the expression of several activation markers (including CD86, MHC-II, CD69, etc.) and exhaustion markers (PD1, CTLA-4, etc.) will be determined. Functional experiments will be conducted on B and T cells to measure B and T cell receptor (BCR and TCR, respectively) signaling responsiveness. In addition, the cytokine production potential will be evaluated in lymphoid and myeloid subsets to assess functionality. Differences in the potential of cytokine production in specific cell subsets between groups will be translated to a systemic level, by quantifying circulating cytokine concentrations in plasma/serum. Quantification and phenotypic assessment of SARSCoV-2-specific B and T cells will be performed using in-house techniques developed at the Department of Viroscience [26]. Cell populations of interest will be further investigated on a transcriptional and epigenetic level, using RNA- and ATAC-seq, respectively. Finally, immunological characteristics will be combined and correlated with clinical parameters to form computationally-calculated immunological profiles.    Virological profile    A virological profile will be created based on several circulating virological factors. For SARSCoV-2, these include the quantification of circulating RNA and spike protein in serum/plasma. For reactivation of latent viruses, these include the quantification of viral load of EBV, CMV, and HHV6 in serum/plasma. Concentrations and neutralization capacity of antibodies (IgM and IgG) against bo

Countries

Netherlands

Contacts

Public ContactR.C.N.M. Leesberg

Erasmus MC, Universitair Medisch Centrum Rotterdam

indieningen.long@erasmusmc.nl0633343648

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)