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NCT05711836 Clinical Trial

Role of HLA Genes and Innate Immunity in the Phenotypic Variability of COVID-19

COVID-19 Clinical Trial

— 3490  

Official title:
Role of HLA Genes and Innate Immunity in the Phenotypic Variability of COVID-19 an Italian, Prospective, Multicenter Association Study

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05711836
Other study ID # HLA GENES
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 14, 2021
Est. completion date September 1, 2022

Study information
Verified date January 2023
Source Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Case-control, prospective retrospective association study of patients infected with SARS-CoV2 and cured by COVID19. Recruited patients were divided into two cohorts (cases: patients with respiratory failure that required hospitalization and ventilatory assistance. Controls: patients who had oligo-asymptomatic forms of COVID19). Patients' blood samples were collected on bibula paper, from which genomic DNA was extracted. Next-generation sequencing of HLA and innate immunity genes was performed on these samples. Genetic risk and protective variants were identified, based on the distribution of allele frequencies in the two cohorts. The aim of the study is to evaluate the role of genes of the HLA system and innate immunity in modulating the host response to SARS-CoV2 infection. The identification of these factors is essential from the perspective of public health (identifying individuals most in need of protection from infection as they are at higher risk of severe forms), basic research (characterization of molecular mechanisms of disease) and therapeutics (through knowledge of basic mechanisms, identify potential therapeutic targets and optimize the protective efficacy of vaccines).

Recruitment information / eligibility
Status Completed
Enrollment 720
Est. completion date September 1, 2022
Est. primary completion date September 1, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Oxygen saturation (SaO2) <94% on room air; <90% if known chronic hypoxic conditions or receiving chronic supplemental oxygen - Respiratory rate >24 breaths/min Exclusion Criteria: - Patients who still test positive for the presence of SARS-CoV-2 genome at the recruitment. - Patients who cannot understand the meaning of the study and/or do not sign the informed consent form.

Study Design

Related Conditions & MeSH terms

Intervention

Genetic:
• HLA-genotyping
HLA genotyping in DNA samples from peripheral blood of patients and controls

Locations
Country Name City State
Italy Francesco Danilo Tiziano Roma Rm

Sponsors (1)
Lead Sponsor Collaborator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary Severe COVID19 52 weeks
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