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

Status Active, not recruiting

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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05769803
Study type	Interventional
Source	IRCCS Sacro Cuore Don Calabria di Negrar
Contact
Status	Active, not recruiting
Phase	N/A
Start date	March 14, 2022
Completion date	September 30, 2023

View Details

See also
Status	Clinical Trial	Phase
Terminated	`NCT04555096` - A Trial of GC4419 in Patients With Critical Illness Due to COVID-19	Phase 2
Completed	`NCT04593641` - This is a Phase 1 Study to Evaluate the Safety,Tolerability and Virology of CT P59 in Patients With Mild Symptoms of Symptoms of Coronavirus Disease (COVID-19)	Phase 1
Recruiting	`NCT05200754` - Trial With or Without Infusion of SARS-CoV-2 Antibody Containing Plasma in High-Risk Patients With COVID-19	Phase 2
Completed	`NCT04583995` - A Study Looking at the Effectiveness, Immune Response, and Safety of a COVID-19 Vaccine in Adults in the United Kingdom	Phase 3
Recruiting	`NCT06255860` - SARS-COV-2 Reinfection and Multisystem Inflammatory Syndrome in Children (MIS-C) Risk: Matched Case-control Study
Recruiting	`NCT04516811` - Therapeutic Use of Convalescent Plasma in the Treatment of Patients With Moderate to Severe COVID-19	Phase 3
Recruiting	`NCT05012826` - Osteopathy and Physiotherapy Compared to Physiotherapy Alone on Fatigue and Functional Status in Long COVID	N/A
Completed	`NCT05007236` - Study to Evaluate the Efficacy and Safety of Oral RP7214, a DHODH Inhibitor, in Patients With Symptomatic Mild COVID-19 Infection.	Phase 2
Recruiting	`NCT06026514` - Phase I Safety Study of B/HPIV3/S-6P Vaccine Via Nasal Spray in Adults	Phase 1
Completed	`NCT05523739` - Safety and Efficacy Study of STI-1558 in Healthy Adults and SARS-CoV-2-Positive Patients	Phase 1
Suspended	`NCT04738136` - Safety, Tolerability and Efficacy Of S-1226 in Moderate Severity Covid-19 Bronchiolitis/Pneumonia	Phase 2
Recruiting	`NCT04584658` - Dysphagia and Dysphonia Outcomes in SARS CoV-2 (COVID-19) Infection (DYADS Study)
Recruiting	`NCT04547114` - Breath Analysis for SARS-CoV-2 in Infected and Healthy Subjects
Completed	`NCT05119348` - Transmission of Coronavirus Disease 2019 (COVID19) in Crowded Environments	N/A
Completed	`NCT05096962` - COVID-19: SARS-CoV-2-CZ-PREVAL-II Study
Recruiting	`NCT04534400` - Automated Quantification of Radiologic Pulmonary Alteration During Acute Respiratory Failure
Completed	`NCT04527354` - Pilot Study to Assess Efficacy and Safety of Treamid in the Rehabilitation of Patients After COVID-19 Pneumonia	Phase 2
Completed	`NCT04583982` - ImmuneSense™ COVID-19 Study
Completed	`NCT05077176` - Phase 3 Booster Vaccination Against COVID-19	Phase 3
Completed	`NCT05584189` - COVID-19 MP Biomedicals Rapid SARS-CoV-2 Antigen Test Usability	N/A