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OpenTrials
Completed

NCT Number: NCT05711836

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

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).

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Key information

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

HLA-genotyping

Genetic

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

Primary outcomes

  1. Severe COVID19

    Time frame: 52 weeks

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Registry information

Official study title

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

Acronym: 3490

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Feb 3, 2023
Registry last updated
Feb 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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