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

NCT05769803 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 61

Last updated 2023-03-15

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • IRCCS Sacro Cuore Don Calabria di Negrar

    lead OTHER

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
4 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-03-14
Primary Completion
2023-02-14
Completion
2023-09-30

Countries

  • Italy

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05769803 on ClinicalTrials.gov