Role of HLA Genes and Innate Immunity in the Phenotypic Variability of COVID-19 (3490)

February 6, 2023 updated by: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

720

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Rm
      • Roma, Rm, Italy, 00168
        • Francesco Danilo Tiziano

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
controls
Genetic: HLA-genotyping
HLA genotyping in DNA samples from peripheral blood of patients and controls
patients
Genetic: HLA-genotyping
HLA genotyping in DNA samples from peripheral blood of patients and controls

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Severe COVID19
Time Frame: 52 weeks
52 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 14, 2021

Primary Completion (ACTUAL)

September 1, 2022

Study Completion (ACTUAL)

September 1, 2022

Study Registration Dates

First Submitted

February 1, 2023

First Submitted That Met QC Criteria

February 1, 2023

First Posted (ACTUAL)

February 3, 2023

Study Record Updates

Last Update Posted (ACTUAL)

February 8, 2023

Last Update Submitted That Met QC Criteria

February 6, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HLA GENES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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