Viral Load Analysis of the SARS-CoV-2 Virus in Nose Versus Mouth Sites
Primary Purpose
Sars-CoV-2 Infection
Status
Active
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Nasal and mouth swab
Sponsored by
About this trial
This is an interventional diagnostic trial for Sars-CoV-2 Infection
Eligibility Criteria
Inclusion Criteria: Patients admitted to IRCCS Sacro Cuore Don Calabria Hospital or health care workers or their family members. Among the family members, also children >4 years old will be included. Subjects verified as positive to SARS-CoV-2 according to either a molecular or antigen test, performed on nasopharyngeal swab, according to current diagnostics. Subjects who will accept to participate to the study and will sign the informed consent. Exclusion Criteria: lack of any needed data or inform consent
Sites / Locations
- IRCCS Sacro Cuore Don Calabria hospital
Outcomes
Primary Outcome Measures
SARS-CoV-2 real time RT-PCR analysis results of the nose and mouth swabs.
SARS-CoV-2 real time RT-PCR analysis results of the nose and mouth swabs.
- Droplet digital PCR (ddPCR) results for SARS-CoV-2
- Droplet digital PCR (ddPCR) results for SARS-CoV-2
- NGS or RT-PCR results for genomic lineages or variant identification.
- NGS or RT-PCR results for genomic lineages or variant identification.
- RT-PCR analysis results for subgenomics
- RT-PCR analysis results for subgenomics
Secondary Outcome Measures
SARS-CoV-2 real time RT-PCR analysis results of the nose and mouth swabs in relationship to the sampling site, to the viral characterization and to the time from diagnosis.
SARS-CoV-2 real time RT-PCR analysis results of the nose and mouth swabs in relationship to the sampling site, to the viral characterization and to the time from diagnosis.
Full Information
NCT ID
NCT05769803
First Posted
March 3, 2023
Last Updated
March 14, 2023
Sponsor
IRCCS Sacro Cuore Don Calabria di Negrar
1. Study Identification
Unique Protocol Identification Number
NCT05769803
Brief Title
Viral Load Analysis of the SARS-CoV-2 Virus in Nose Versus Mouth Sites
Official Title
Viral Load Analysis of the SARS-CoV-2 Virus in Nose Versus Mouth Sites
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 14, 2022 (Actual)
Primary Completion Date
February 14, 2023 (Actual)
Study Completion Date
September 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
IRCCS Sacro Cuore Don Calabria di Negrar
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
It is a single-center, non-profit experimental study, intended to evaluate the viral load of SARS COV 2 in nasal and oral samples of positive subjects to evaluate any variation and understand which is the most suitable site for carrying out the swab.
Detailed Description
Experimental study on de-identified, biological samples (nasal and buccal swab).
The study will be performed on patients admitted to IRCCS Sacro Cuore Don Calabria Hospital or health care workers or their family members, who tested positive for SARS-CoV-2 by either a molecular or antigen test, performed on nasopharyngeal swab, according to current diagnostics.
Among the family members, also children >4 years old will be included. The reason for including children and young subjects is based on data indicating that they seems to be highly sensitive to Omicron infection and that their vaccination status could influence viral load. The nose and mouth swab are poor invasive and they could be well tolerated also by children.
Whinin 7 days from diagnosis, the subjects will be requested to sample another two specimens i.e. nasal swab and mouth swab, that will be tested for the presence of SARS-CoV-2 RNA. Results, expressed as cycle threshold will be then compared to analyze viral loads from the two different sites.
Moreover, an aliquot will be retro-transcribed into cDNA and sequenced by Next Generation Sequencing (NGS) to obtain the virus entire genome sequence or evaluated by RT-PCR for variant determination.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sars-CoV-2 Infection
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
61 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Diagnostic Test
Intervention Name(s)
Nasal and mouth swab
Intervention Description
Whinin 7 days from diagnosis, the subjects will be requested to sample another two specimens i.e. nasal swab and mouth swab, that will be tested for the presence of SARS-CoV-2 RNA. Results, expressed as cycle threshold will be then compared to analyze viral loads from the two different sites.
Moreover, an aliquot will be retro-transcribed into cDNA and sequenced by Next Generation Sequencing (NGS) to obtain the virus entire genome sequence or evaluated by RT-PCR for variantdetermination.
Primary Outcome Measure Information:
Title
SARS-CoV-2 real time RT-PCR analysis results of the nose and mouth swabs.
Description
SARS-CoV-2 real time RT-PCR analysis results of the nose and mouth swabs.
Time Frame
2 months
Title
- Droplet digital PCR (ddPCR) results for SARS-CoV-2
Description
- Droplet digital PCR (ddPCR) results for SARS-CoV-2
Time Frame
2 months
Title
- NGS or RT-PCR results for genomic lineages or variant identification.
Description
- NGS or RT-PCR results for genomic lineages or variant identification.
Time Frame
2 months
Title
- RT-PCR analysis results for subgenomics
Description
- RT-PCR analysis results for subgenomics
Time Frame
2 months
Secondary Outcome Measure Information:
Title
SARS-CoV-2 real time RT-PCR analysis results of the nose and mouth swabs in relationship to the sampling site, to the viral characterization and to the time from diagnosis.
Description
SARS-CoV-2 real time RT-PCR analysis results of the nose and mouth swabs in relationship to the sampling site, to the viral characterization and to the time from diagnosis.
Time Frame
2 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Patients admitted to IRCCS Sacro Cuore Don Calabria Hospital or health care workers or their family members. Among the family members, also children >4 years old will be included.
Subjects verified as positive to SARS-CoV-2 according to either a molecular or antigen test, performed on nasopharyngeal swab, according to current diagnostics.
Subjects who will accept to participate to the study and will sign the informed consent.
Exclusion Criteria:
lack of any needed data or inform consent
Facility Information:
Facility Name
IRCCS Sacro Cuore Don Calabria hospital
City
Negrar
State/Province
Verona
ZIP/Postal Code
37024
Country
Italy
12. IPD Sharing Statement
Learn more about this trial
Viral Load Analysis of the SARS-CoV-2 Virus in Nose Versus Mouth Sites
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