Viral Load Analysis of the SARS-CoV-2 Virus in Nose Versus Mouth Sites

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Sars-CoV-2 Infection
• Intervention / Treatment: Diagnostic test: Nasal and mouth 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.

• Study Type: Interventional
• Enrollment (Actual): 61
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Verona
    • Negrar, Verona, Italy, 37024
      • IRCCS Sacro Cuore Don Calabria hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	2 months

Collaborators and Investigators

• Sponsor: IRCCS Sacro Cuore Don Calabria di Negrar

Study record dates

Study Major Dates

• Study Start (Actual): March 14, 2022
• Primary Completion (Actual): February 14, 2023
• Study Completion (Anticipated): September 30, 2023

Study Registration Dates

• First Submitted: March 3, 2023
• First Submitted That Met QC Criteria: March 14, 2023
• First Posted (Actual): March 15, 2023

Study Record Updates

• Last Update Posted (Actual): March 15, 2023
• Last Update Submitted That Met QC Criteria: March 14, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: 2022-04

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No