NCT04516850

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2020

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 8, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 16, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 18, 2020

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 21, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 21, 2023

Completed
Last Updated

April 25, 2023

Status Verified

April 1, 2023

Enrollment Period

2.7 years

First QC Date

August 16, 2020

Last Update Submit

April 21, 2023

Conditions

Covid19

Outcome Measures

Primary Outcomes (3)

  • Expression of receptors and activating proteases

    Determination of the level of expression of the mRNA genes

    1 year

  • Prevalencen of olymorphisms of the HSD3B1

    Determination of the prevalence of polymorphisms of the HSD3B1 patients with severe and mild-moderate SARS-CoV-2 infection

    1 year

  • Association of polymorphisms of the HSD3B1

    Evaluation of the association of polymorphisms of the HSD3B1 with clinico-pathological parameters

    1 year

Study Arms (2)

Patients tested for COVID-19

The nasopharyngeal swabs taken from patients tested for Covid-19 who resulted infected and non-infected will be analyzed to evaluate the expression of receptors and activating proteases mediating SARS-CoV-2.

Genetic: Expression of receptors and activating proteases

Patients with mild-moderate and severe SARS-CoV-2 infection

Formalin-fixed paraffin will be analysed to determine the association between polymorphism of the HSD3B1 gene and outcomes in COVID-19 affected patients

Genetic: Polymorphism of the HSD3B1

Interventions

Expression of receptors and activating proteasesGENETIC

Level of expression of the mRNA of the genes encoding ACE2, TMPRSS2, TMPRSS4 and AR along with reference genes (beta-actin and EPCAM) in nasopharyngeal swabs taken from patients tested for COVID-19

Patients tested for COVID-19
Polymorphism of the HSD3B1GENETIC

Formalin-fixed paraffin embedded tissue blocks will be amplified using polymerase chain reaction (PCR) based experiments followed by direct sequencing (Sanger sequencing)

Patients with mild-moderate and severe SARS-CoV-2 infection

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Subjects tested for COVID-19

You may qualify if:

  • 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).

You may not qualify if:

  • \- Documented refusal.
  • Sub-project 2
  • 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).
  • \- Documented refusal.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Oncology Institute of Southern Switzerland (IOSI)

Bellinzona, 6500, Switzerland

Location

Clinica Luganese Moncucco

Lugano, 6900, Switzerland

Location

Biospecimen

Retention: SAMPLES WITH DNA

Sub-project 1: nasopharyngeal swabs Sub-project 2: tissue samples

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Ricardo Pereira Mestre, MD

    Oncology Institute of Southern Switzerland (IOSI)

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

August 16, 2020

First Posted

August 18, 2020

Study Start

June 8, 2020

Primary Completion

February 21, 2023

Study Completion

February 21, 2023

Last Updated

April 25, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations

CH(2)