Primary objective: To investigate the baseline systemic immune profile in COVID-19 patients using mRNA expression profiling, and to connect that to clinical outcome in order to identify prognostic and predictive markers that can help in decision…
ID
Source
Brief title
Condition
- Viral infectious disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To investigate the baseline systemic immune profile in COVID-19 patients using
mRNA expression profiling, and to connect that to clinical outcome in order to
identify prognostic and predictive markers that can help in decision making for
individual patients.
Secondary outcome
* To investigate the individual systemic immune profile changes in COVID-19
patients using mRNA expression profiling, and to connect that to clinical
outcome.
* To scrutinize the pathogenesis of COVID-19 by connecting the circulating
immune profile to that infiltrated in the lung samples of deceased patients.
Background summary
Currently it is not clear which patients who are admitted to the hospital with
a SARS-CoV-2 infection will benefit from treatment at either the general COVID
ward or the Intensive Care unit. Based on clinical features, pathology and the
pathogenesis of acute respiratory disorder it is suggested that the excessive
inflammation, oxidation, and an exaggerated immune response may very likely
contribute to COVID-19 pathology. This leads to a cytokine storm and subsequent
progression to acute lung injury, diffuse lung embolism and sometimes to death.
In early stages of Coronavirus infection, dendritic cells and epithelial cells
are activated and express a cluster of pro-inflammatory cytokines and
chemokines including IL-1*, IL-2, IL-6, IL-8, both IFN-*/*, and many other
secreted molecules that are under the control of the immune system. However,
the balanced immune system, including the innate immunity is severely disturbed
in some the SARS-CoV-2 infected patients which contributes to the progression
in disease. We believe that monitoring the immunological changes (cell type
ratios, cytokines and chemokines) induced by the SARS-CoV-2 virus will lead to
discovering prognostic or predictive markers that may assist in decision making
and hopefully offers new treatment options.
Study objective
Primary objective: To investigate the baseline systemic immune profile in
COVID-19 patients using mRNA expression profiling, and to connect that to
clinical outcome in order to identify prognostic and predictive markers that
can help in decision making for individual patients. Secondary objectives: 1)
To investigate the individual systemic immune profile changes in COVID-19
patients using mRNA expression profiling, and to connect that to clinical
outcome. 2) To scrutinize the pathogenesis of COVID-19 by connecting the
circulating immune profile to that infiltrated in the lung samples of deceased
patients.
Study design
Case control study.
Study burden and risks
For the participating patients there is no direct benefit. However, if we are
able to determine an immune profile which can predict clinical outcome this
will benefit future patients during their treatment course. Unnecessary
Intensive Care treatment can be avoided in elderly patients if the profile
predicts a negative outcome. The extra burden consists of a maximum of 3 extra
blood collections, however these collections will take place during a standard
blood collection or from a permanent peripheral vein catheter.
's-Gravendijkwal 230
Rotterdam 3015 CE
NL
's-Gravendijkwal 230
Rotterdam 3015 CE
NL
Listed location countries
Age
Inclusion criteria
* Age 18 years and older;
* Proven SARS-CoV-2 infection;
* Patient will be admitted to either the general COVID ward or the Internsive
Care unit;
* Written informed consent.
Exclusion criteria
* Unable to provide written informed consent.
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 | NL73767.078.20 |