Clinical trial NCT04403061: Th1/Th2/Th17/TREG and TLRs Activation/KIR for COVID 19 Prediction of Outcome
Official title: Th1/Th2/Th17/TREG Response and TLRs Activation/KIR Receptors for Predicting the Evolution of the SARS Cov-2 Infected Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Disease, Viral
Cytokine Release Syndrome
TLRs
Lead sponsor: Asociacion para el Estudio de las Enfermedades Infecciosas
Sponsor class: NETWORK
Collaborators: name: Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
First posted: 2020-05-27
Enrollment: 106
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with a diagnosis of COVID-19

Brief summary: 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

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Patients with a diagnosis of COVID-19 (PCR confirmed)

Exclusion Criteria:

* No informed consent
* Presence of chronic therapy with immunomodulators, corticoids or antineoplastic agents.

Primary outcomes:
measure: Changes in cytokines associated with SARS CoV-2 infection
timeFrame: 1 month
measure: Evaluation of cellular response
timeFrame: 1 month
measure: TLRs activation
timeFrame: 1 month
measure: KIR phenotype determination
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Hospital Ramon y Cajal
Study officials:
References: