Th1/Th2/Th17/TREG and TLRs Activation/KIR for COVID 19 Prediction of Outcome (Resistir)

Th1/Th2/Th17/TREG Response and TLRs Activation/KIR Receptors for Predicting the Evolution of the SARS Cov-2 Infected Patients

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

Study Overview

• Status: Completed
• Conditions: Cytokine Release Syndrome; Disease, Viral; TLRs
• Intervention / Treatment: Diagnostic test: Cytokines measurement; Diagnostic test: Cellular response; Diagnostic test: TLRs activation measurement; Diagnostic test: KIR phenotype evaluation

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.

• Study Type: Observational
• Enrollment (Actual): 106

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain, 28034
    • Hospital Ramón Y Cajal

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with a diagnosis of COVID-19

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Changes in cytokines associated with SARS CoV-2 infection	1 month
Evaluation of cellular response	1 month
TLRs activation	1 month
KIR phenotype determination	1 month

Collaborators and Investigators

• Sponsor: Asociacion para el Estudio de las Enfermedades Infecciosas
• Collaborators: Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 22, 2020
• Primary Completion (ACTUAL): December 22, 2020
• Study Completion (ACTUAL): January 10, 2021

Study Registration Dates

• First Submitted: May 23, 2020
• First Submitted That Met QC Criteria: May 26, 2020
• First Posted (ACTUAL): May 27, 2020

Study Record Updates

• Last Update Posted (ACTUAL): January 12, 2021
• Last Update Submitted That Met QC Criteria: January 11, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Shock; Virus Diseases; Cytokine Release Syndrome
• Other Study ID Numbers: EC128/20

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Pending to establish collaboration to share cytokine measurements

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No