HSD3B1 Gene Polymorphisms With Outcomes in SARS-CoV-2 Infected Patients

Completed

• Conditions: Covid19

• Registration Number: NCT04516850
• Lead Sponsor: Ricardo Pereira Mestre

Brief Summary

The study includes 2 sub-projects.

Sub-project 1: The aim is to evaluate the expression of receptors and activating proteases mediating SARS-CoV-2 entry and spreading in the local population of Ticino.

Sub-project 2: The aim is to investigate the association between the HSD3B1 gene variations and outcome of COVID-19 in the local population of Ticino.

Detailed Description

Sub-project 1:

This is an observational retrospective study that aims to evaluate the expression of receptors and activating proteases mediating SARS-CoV-2 entry and spreading in the local population of Ticino. The level of expression of these factors will be compared between infected and non-infected subjects. The sub-project will examine RNA samples from nasopharyngeal swabs taken from subjects tested for COVID-19.

Sub-project 2:

This is a haplotype- and diplotype-based case-control retrospective study that aims to investigate the association between the HSD3B1 gene variations and outcome of COVID-19 in the local population of Ticino. The gene status of HSD3B1 will be defined and compared between two groups of patients: the patients who experienced a severe SARS-CoV-2 infection (severe pulmonary insufficiency, ICU admission, eventually death) and the group with a mild-moderate COVID-19 disease without pulmonary insufficiency and oxygen need.

Study Timeline

• Study Start: 2020-06-08
• Study First Submitted: 2020-08-16
• Study First Submitted QC: 2020-08-16
• Study First Posted: 2020-08-18
• Primary Completion: 2023-02-21
• Study Completion: 2023-02-21
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-21
• Last Update Posted: 2023-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

• Availability of RNA extracted from nasopharyngeal swabs taken from subjects tested for COVID-19;
• Subject is aged 18 years or over;
• Written informed consent (for SARS-CoV-2 positive patients only; see §5 for further details).

Exclusion Criteria

• Documented refusal.

Sub-project 2

Inclusion Criteria:

• Female and male hospitalized SARS-CoV-2 patients;
• Patient is aged 18 years or over;
• Availability of archival tissue samples collected at any time before SARS-CoV-2 infection for any clinical reason;
• Clinico-pathological characteristics of the COVID-19 and clinical outcomes recorded in the EOC and Clinica Luganese Moncucco database;
• Written informed consent (see §5 for further details).

Exclusion Criteria:

• Documented refusal.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Expression of receptors and activating proteases	1 year	Determination of the level of expression of the mRNA genes
Prevalencen of olymorphisms of the HSD3B1	1 year	Determination of the prevalence of polymorphisms of the HSD3B1 patients with severe and mild-moderate SARS-CoV-2 infection
Association of polymorphisms of the HSD3B1	1 year	Evaluation of the association of polymorphisms of the HSD3B1 with clinico-pathological parameters

Trial Locations

Locations (2)

Oncology Institute of Southern Switzerland (IOSI); 🇨🇭 Bellinzona, Switzerland

Clinica Luganese Moncucco; 🇨🇭 Lugano, Switzerland