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

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS (Other)

Overall Status

Completed

CT.gov ID

NCT05711836

Collaborator

(none)

720

Enrollment

Location

19.5

Actual Duration (Months)

36.8

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
COVID-19	Genetic: HLA-genotyping

Study Design

Study Type:

Observational

Actual Enrollment :

720 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Jan 14, 2021

Actual Primary Completion Date :

Sep 1, 2022

Actual Study Completion Date :

Sep 1, 2022

Arms and Interventions

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

Arm

Intervention/Treatment

patients

Genetic: HLA-genotyping

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

controls

Genetic: HLA-genotyping

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

Outcome Measures

Primary Outcome Measures

Severe COVID19 [52 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Francesco Danilo Tiziano	Roma	Rm	Italy	00168

Sponsors and Collaborators

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

ClinicalTrials.gov Identifier:

NCT05711836

Other Study ID Numbers:

HLA GENES

First Posted:

Feb 3, 2023

Last Update Posted:

Feb 8, 2023

Last Verified:

Jan 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

COVID-19

Study Results

No Results Posted as of Feb 8, 2023