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

Sponsor
Asociacion para el Estudio de las Enfermedades Infecciosas (Other)
Overall Status
Completed
CT.gov ID
NCT04403061
Collaborator
Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal (Other)
106
1
7.7
13.8

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Actual Enrollment :
106 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Th1/Th2/Th17/TREG Response and TLRs Activation/KIR Receptors for Predicting the Evolution of the SARS Cov-2 Infected Patients
Actual Study Start Date :
May 22, 2020
Actual Primary Completion Date :
Dec 22, 2020
Actual Study Completion Date :
Jan 10, 2021

Outcome Measures

Primary Outcome Measures

  1. Changes in cytokines associated with SARS CoV-2 infection [1 month]

  2. Evaluation of cellular response [1 month]

  3. TLRs activation [1 month]

  4. KIR phenotype determination [1 month]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 100 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hospital Ramon y Cajal Madrid Spain 28034

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Asociacion para el Estudio de las Enfermedades Infecciosas
ClinicalTrials.gov Identifier:
NCT04403061
Other Study ID Numbers:
  • EC128/20
First Posted:
May 27, 2020
Last Update Posted:
Jan 12, 2021
Last Verified:
Jan 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 12, 2021