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

NCT05711836 | Completed

• 1 other identifier: HLA GENES
• Study Type: observational
• Target: 720
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

COVID-19

Outcome Measures

Primary Outcomes (1)

• Severe COVID19

  52 weeks

Study Arms (2)

patients

Genetic: HLA-genotyping

controls

Genetic: HLA-genotyping

Interventions

HLA-genotyping GENETIC

HLA genotyping in DNA samples from peripheral blood of patients and controls

controls; patients

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects healed from severe forms of COVID19 and oligo/asymptomatic subjects as controls

You may qualify if:

• Oxygen saturation (SaO2) \<94% on room air; \<90% if known chronic hypoxic conditions or receiving chronic supplemental oxygen
• Respiratory rate \>24 breaths/min

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Francesco Danilo Tiziano

Roma, Rm, 00168, Italy

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 1, 2023
• First Posted: February 3, 2023
• Study Start: January 14, 2021
• Primary Completion: September 1, 2022
• Study Completion: September 1, 2022
• Last Updated: February 8, 2023

Record last verified: 2023-01

Locations

IT (1)