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

Sars-CoV-2 Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05769803
• Other study ID #: 2022-04
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 14, 2022
• Est. completion date: September 30, 2023

Study information

• Verified date: March 2023
• Source: IRCCS Sacro Cuore Don Calabria di Negrar
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 61
• Est. completion date: September 30, 2023
• Est. primary completion date: February 14, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Sars-CoV-2 Infection

Intervention

Diagnostic Test:
• Nasal and mouth swab
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.

Locations

Country	Name	City	State
Italy	IRCCS Sacro Cuore Don Calabria hospital	Negrar	Verona

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS Sacro Cuore Don Calabria di Negrar

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	- Droplet digital PCR (ddPCR) results for SARS-CoV-2	- Droplet digital PCR (ddPCR) results for SARS-CoV-2	2 months
Primary	- NGS or RT-PCR results for genomic lineages or variant identification.	- NGS or RT-PCR results for genomic lineages or variant identification.	2 months
Primary	- RT-PCR analysis results for subgenomics	- RT-PCR analysis results for subgenomics	2 months
Secondary	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