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

NCT04403061 | Completed DMC

• 1 other identifier: EC128/20
• Study Type: observational
• Target: 106
• Locations: 1 country
• Sites: 1

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

Conditions

Disease, Viral; Cytokine Release Syndrome; TLRs

Outcome Measures

Primary Outcomes (4)

• 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

Interventions

Cytokines measurement DIAGNOSTIC_TEST

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).

Cellular response DIAGNOSTIC_TEST

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).

TLRs activation measurement DIAGNOSTIC_TEST

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).

KIR phenotype evaluation DIAGNOSTIC_TEST

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.

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with a diagnosis of COVID-19

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

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

Study Sites (1)

Hospital Ramon y Cajal

Madrid, 28034, Spain

Location

MeSH Terms

Conditions

Virus Diseases; Cytokine Release Syndrome

Interventions

Immunity, Cellular

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Intervention Hierarchy (Ancestors)

Adaptive Immunity; Immunity; Immune System Phenomena

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2020
• First Posted: May 27, 2020
• Study Start: May 22, 2020
• Primary Completion: December 22, 2020
• Study Completion: January 10, 2021
• Last Updated: January 12, 2021

Record last verified: 2021-01

Locations

ES (1)