Covid19NCT04516850
HSD3B1 Gene Polymorphisms With Outcomes in SARS-CoV-2 Infected Patients
An observational study of Covid19, run by Ricardo Pereira Mestre at 2 sites in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19
- What is being tested?
- Expression of receptors and activating proteases and Polymorphism of the HSD3B1
- How many people
- 400 participants
- Where
- 2 sitesSwitzerland
- Study dates
- 8 Jun 2020to 21 Feb 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects tested for COVID-19
Who may be able to join
- 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).
- 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).
Who cannot join
- Documented refusal.
- Sub-project 2
- Documented refusal.
Trial locations and contacts
2 sites in 1 country.
Switzerland2 sites
Oncology Institute of Southern Switzerland (IOSI)
Bellinzona, 6500
Clinica Luganese Moncucco
Lugano, 6900
About this study
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
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.
Read the 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.
- Conditions
- Covid19
- Being tested
- Expression of receptors and activating proteases, Polymorphism of the HSD3B1
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
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)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Genetic: Polymorphism of the HSD3B1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Expression of receptors and activating proteases
Determination of the level of expression of the mRNA genes
Measured: 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
Measured: 1 year
Association of polymorphisms of the HSD3B1
Evaluation of the association of polymorphisms of the HSD3B1 with clinico-pathological parameters
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2020
- Study start8 Jun 2020
- Primary completion21 Feb 2023
- Study completion21 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ricardo Pereira Mestre
- Sponsor type
- University, hospital or other
- Collaborators
- Institute of Oncology Research (IOR), Istituto Cantonale di Patologia
- Responsible party
- Sponsor-investigator, Ricardo Pereira Mestre, Oncology Institute of Southern Switzerland
- Investigators
- Ricardo Pereira Mestre, MD, Study chair, Oncology Institute of Southern Switzerland (IOSI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04516850
- Sponsor's protocol ID
- COVID19-GeneExp
- Status last verified
- Apr 2023
- First submitted
- 16 Aug 2020
- Last updated
- 25 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04516850
- Acronym / sponsor ID
- COVID19-GeneExp
- Conditions
- Covid19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Ricardo Pereira MestreUniversity, hospital or other
- Collaborators
- Institute of Oncology Research (IOR), Istituto Cantonale di Patologia
- Study start
- 8 Jun 2020 (actual)
- Primary completion
- 21 Feb 2023 (actual)
- Study completion
- 21 Feb 2023 (actual)
- First posted
- 18 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients tested for COVID-19 | – | Genetic: Expression of receptors and activating proteasesThe 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. |
| Patients with mild-moderate and severe SARS-CoV-2 infection | – | Genetic: Polymorphism of the HSD3B1Formalin-fixed paraffin will be analysed to determine the association between polymorphism of the HSD3B1 gene and outcomes in COVID-19 affected patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects tested for COVID-19
Key inclusion criteria (8 listed)
- 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).
- Female and male hospitalized SARS-CoV-2 patients;
- Patient is aged 18 years or over;
Key exclusion criteria (3 listed)
- Documented refusal.
- Sub-project 2
- Documented refusal.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Expression of receptors and activating proteasesLevel 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 | Genetic | Patients tested for COVID-19 |
| Polymorphism of the HSD3B1Formalin-fixed paraffin embedded tissue blocks will be amplified using polymerase chain reaction (PCR) based experiments followed by direct sequencing (Sanger sequencing) | Genetic | Patients with mild-moderate and severe SARS-CoV-2 infection |
Primary outcome
Expression of receptors and activating proteases
Time frame: 1 year
Determination of the level of expression of the mRNA genes
Prevalencen of olymorphisms of the HSD3B1
Time frame: 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
Time frame: 1 year
Evaluation of the association of polymorphisms of the HSD3B1 with clinico-pathological parameters
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ricardo Pereira Mestre, MD study chair
Oncology Institute of Southern Switzerland (IOSI)
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19, run by Ricardo Pereira Mestre at 2 sites in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Expression of receptors and activating proteases (time frame: 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2023.