An observational study in Disease, Viral, Cytokine Release Syndrome and TLRs, sponsored by Asociacion para el Estudio de las Enfermedades Infecciosas. Completed at 1 site in Spain. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2021-01-12.
Sponsored by Asociacion para el Estudio de las Enfermedades Infecciosas · Observational
To ascertain globally the changes in the cytokines involved and TLRs/KIR activation in patients admitted to the hospital with a COVID-19 diagnosis, and the changes after initiation of the different therapies
COVID-19 is a disease with an initial viral phase followed, usually at the 7th day, of an inflammatory state (cytokine storm) leading to respiratory distress, ICU admission and risk of death. Thus, several biological agents, antagonists of the different cytokines (IL-6, IL-1) have been used for patients with severe disease. However, there are no data about the cytokine changes, at admission and after therapy, and its predictive value, a fundamental knowledge to establish the best therapeutic strategy.
The first line of immune defense is the interaction of the virus with innate immunity cell members. The toll like receptors (TLRs) family is a group of pattern recognition receptors that include many different molecules (21-23). These bindings can activate dendritic cells, monocytes, macrophages. There is an important RNA and DNA connection, activation of TLRs, the production of type I interferons, and the development of some autoimmune diseases. TLR7 and TLR8 specifically recognize simple-chain RNA of viruses and are expressed in endosomal membranes. TLR8 is expressed in regulatory cells (Treg) and its activation results in inhibition of its regulatory functions. Natural killer cells (NK) respond to alterations of class I HLA molecules present in infected cells (24-26). An increase in class I HLA expression could lead to an increase in NK activation by increasing its ability to produce IFN-gamma. Therefore, the reasons for KIR binding are often variable between individuals and between populations.
914 studies on the registry are indexed under Virus Diseases; 110 are open to participants now.
This study's enrollment of 106 is below the median of 300 across 275 observational studies indexed under Virus Diseases.
Browse Virus Diseases studies →Asociacion para el Estudio de las Enfermedades Infecciosas is the lead sponsor of 8 studies on the registry; none are open to participants now.
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Patients with a diagnosis of COVID-19
Exclusion Criteria:
Quantification of plasma cytokine levels of human GM-CSF, IFN-α, IFN-γ, IL-2, IL-4, IL-5, IL-6, IL-9, IL-10, IL-12p70, IL-17A, and TNF-α using multiplex technol-ogy (quantitative measure).
SARS-CoV-2 peptides (Prot-S, Pros-N and Port-M) will be used to activate CD4 and CD8 T cells. Cytokines released, such as IFNg, TNFa, IL4, IL17A, and IL2, from each cell subset will be measured by flow cytometry (quantitative measure).
After specific cell activation through TLR7/8 receptors, such as resiquimod, ORN R-0002, ORN R-0006, ORN R-1263, ORN R-2336, and controls as Poly (I:C), the release of IFNa, IFNg, TNFa, IL12, and IL6 will be analyzed (quantitative measure).
Characterization of the presence of 14 genes plus 2 pseudogenes of KIR gene family (qualitative genotyping) by PCR, mRNA expression profiling (quantitative measures) by RT-PCR, and phenotyping of human NK cells analyzing different KIR receptors (quantitative measure) by flow cytometry, will be analyzed.
Changes in cytokines associated with SARS CoV-2 infection
Time frame: 1 month
Evaluation of cellular response
Time frame: 1 month
TLRs activation
Time frame: 1 month
KIR phenotype determination
Time frame: 1 month
Plan to share: Undecided — Pending to establish collaboration to share cytokine measurements
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This study is completed, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.
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Asociacion para el Estudio de las Enfermedades Infecciosas