Characterization of aberrant immune response in post-COVID using innovative signal transduction pathway technology (LC-STP)

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 50

Inclusion Criteria

Long-COVID patients
• Age >= 18 years, <65 years
• Past COVID-19 diagnosis, based on
o Positive PCR
o Positive Sars-Cov2 serology
o Positive rapid antigen test
o Typical clinical syndrome during the first pandemic wave, when testing was
not possible
• Long-COVID-19 diagnosis based on World Health Organization consensus
diagnosis
(*Post COVID-19 condition occurs in individuals with a history of probable or
confirmed SARS CoV-2 infection, usually 3 months from the onset of COVID-19
with symptoms and that last for at least 2 months and cannot be explained by an
alternative diagnosis. Symptoms may be new onset following initial recovery
from an acute COVID-19 episode or persist from the initial illness. Symptoms
may also fluctuate or relapse over time)*.
o Ref
https://www.who.int/publications/i/item/WHO-2019-nCoV-Post_COVID19_condition-Cli
nical_case_definition-2021.1
• Overall functioning <70% compared to functioning prior to onset of
Long-COVID/ COVID19 infection
• Presence of post-exertional malaise
• Provided written informed consent
• Long COVID symptoms present > 6 months

Healthy controls
• Age >= 18 years, <65 years
• Past COVID-19 diagnosis, based on
o Positive PCR
o Positive Sars-Cov2 serology
o Positive rapid antigen test
o Typical clinical syndrome during the first pandemic wave, when testing was
not possible
• No clinical diagnosis of long-COVID, good recovery. Overall functioning >95%
compared to functioning prior COVID-19 infection
• Self-reported general good wellbeing
• Provided written informed consent

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
• Alternative diagnosis that may explain their clinical symptoms
• Re-infection or booster vaccination 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

Healthy controls
• 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 or booster vaccination in the past 3 months.

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Transcriptome analysis by STP technology delivers a an STP activity score for<br /><br>15 STPs, for each analyzed immune cell type sample (CD4+ T-, CD8+ T-,<br /><br>B-lymphocytes, NK cells, monocytes). The main study parameters are the STP<br /><br>activity score of 15 STP pathways of the 5 types of immune cells. The main goal<br /><br>is to compare STP activity between long-COVID and controls. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>We will biologically interpretate the abnormal immune function/ STP activity<br /><br>profile in individual long-COVID patients followed by identification and<br /><br>description of potential STP drug targets by DCDC-Tx.<br /><br>If applicable, we will assess for long-COVID subtypes, based on interpretation<br /><br>of STP results (regarding differential immune cell dysfunction and treatment<br /><br>targets) in combination with clinical and/or other laboratory parameters.<br /><br>Several biomarkers implicated in long-COVID and related to immune dysregulation<br /><br>will be measured in serum (including but not limited to) cortisol, cytokines<br /><br>(primarily CCL2, CCL11, galectin-1, galectin-9, IL-6, IL-8, IL-10, CXCL10 and<br /><br>sCD163 (a macrophage activation marker).</p><br>