Official Title
Viral Load Analysis of the SARS-CoV-2 Virus in Nose Versus Mouth Sites
Brief Summary

It is a single-center, non-profit experimental study, intended to evaluate the viral loadof SARS COV 2 in nasal and oral samples of positive subjects to evaluate any variationand 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.

Active, not recruiting
SARS-CoV-2 Infection

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.

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

Eligibility Gender
All
Eligibility Age
Minimum: 4 Years ~ Maximum: N/A
Countries
Italy
Locations

IRCCS Sacro Cuore Don Calabria hospital
Negrar, Verona, Italy

Not Provided

IRCCS Sacro Cuore Don Calabria di Negrar
NCT Number
MeSH Terms
COVID-19