Clinical trial NCT04516850: HSD3B1 Gene Polymorphisms With Outcomes in SARS-CoV-2 Infected Patients
Official title: An Exploratory Analysis of the Expression of Receptors and Activating Proteases Mediating SARS-CoV-2 Entry and the Association Between HSD3B1 Gene Polymorphisms With Outcomes in SARS-CoV-2 Infected Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid19
Lead sponsor: Oncology Institute of Southern Switzerland
Sponsor class: OTHER
Collaborators: name: Institute of Oncology Research (IOR)
name: Istituto Cantonale di Patologia
First posted: 2020-08-18
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects tested for COVID-19

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.

Eligibility criteria: Sub-project 1

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.

Primary outcomes:
measure: Expression of receptors and activating proteases
timeFrame: 1 year
measure: Prevalencen of olymorphisms of the HSD3B1
timeFrame: 1 year
measure: Association of polymorphisms of the HSD3B1
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Bellinzona
country: Switzerland
facility: Oncology Institute of Southern Switzerland (IOSI)
city: Lugano
country: Switzerland
facility: Clinica Luganese Moncucco
Study officials:
affiliation: Oncology Institute of Southern Switzerland (IOSI)
name: Ricardo Pereira Mestre, MD
role: STUDY_CHAIR
References: