Viral Load Analysis of the SARS-CoV-2 Virus in Nose Versus Mouth Sites
1 other identifier
interventional
61
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2022
1 active site
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
March 14, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 14, 2023
CompletedFirst Submitted
Initial submission to the registry
March 3, 2023
CompletedFirst Posted
Study publicly available on registry
March 15, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2023
CompletedMarch 15, 2023
March 1, 2023
11 months
March 3, 2023
March 14, 2023
Conditions
Outcome Measures
Primary Outcomes (4)
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.
2 months
- Droplet digital PCR (ddPCR) results for SARS-CoV-2
\- Droplet digital PCR (ddPCR) results for SARS-CoV-2
2 months
- NGS or RT-PCR results for genomic lineages or variant identification.
\- NGS or RT-PCR results for genomic lineages or variant identification.
2 months
- RT-PCR analysis results for subgenomics
\- RT-PCR analysis results for subgenomics
2 months
Secondary Outcomes (1)
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.
2 months
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- lack of any needed data or inform consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
IRCCS Sacro Cuore Don Calabria hospital
Negrar, Verona, 37024, Italy
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 3, 2023
First Posted
March 15, 2023
Study Start
March 14, 2022
Primary Completion
February 14, 2023
Study Completion
September 30, 2023
Last Updated
March 15, 2023
Record last verified: 2023-03