Respiratory Viral Infection Clinical Trial
Official title:
Clinical Evaluation of SARS-COV-2, Influenza and RSV 8-Well MT-PCR Panel for In Vitro Diagnostics
This study is a prospective accuracy observational study to evaluate the performance of the Highplex System SARS-Cov-2, Influenza and RSV 8-well in vitro diagnostic medical device panel and generate performance data. The precision of results will be evaluated in concordance with the comparator predicate device panel BioFire Respiratory Panel 2.1 (RP2.1).
This study is a prospective accuracy observational study to evaluate the performance of the Highplex System SARS-Cov-2, Influenza and RSV 8-well in vitro diagnostic medical device panel and generate performance data. The precision of results will be evaluated in concordance with the comparator predicate device panel BioFire Respiratory Panel 2.1 (RP2.1). This study will utilise prospective sample respiratory swabs from individuals with paired test data, presenting with influenza-like symptoms (e.g., cough, nasal congestion, rhinorrhoea, sore throat, fever, headache, myalgia), as well as asymptomatic individuals. To meet the target number of 400 positive samples (50 samples per target; 8 targets in total), a required sampling size of 1000 participants will need to be screened to account for unviable samples and screen failures. Prospective respiratory samples will include nasopharyngeal swabs as described in Intended Use of the product. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Terminated |
NCT04898023 -
Zinc and Green Tea Extract for Community Respiratory Viral Infections
|
Phase 2 | |
Withdrawn |
NCT04842331 -
PREvent Viral Exposure and Transmission Study: a COVID-19 (SARS-CoV-2) PEP Study (PREVENT)
|
Phase 2/Phase 3 | |
Completed |
NCT02260596 -
Respiratory Viral Infections in Pediatric Transplantation
|
N/A | |
Not yet recruiting |
NCT06099873 -
A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Trial of ZX-7101A Tablets to Evaluate the Efficacy and Safety in the Treatment of Uncomplicated Influenza in Adolescents
|
Phase 3 | |
Completed |
NCT04898140 -
The Evaluation of Cellular and Humoral Immunity to COVID-19 in Moscow Residents
|
||
Completed |
NCT04611061 -
Kagocel® for the Prevention of ARVI and Influenza in Adults Health Care Workers
|
||
Not yet recruiting |
NCT05618483 -
Xylitol Based Nasal Spray for COVID-19 Treatment
|
N/A | |
Recruiting |
NCT06149494 -
RCT of Vapendavir in Patients With COPD and Human Rhinovirus/Enterovirus Upper Respiratory Infection
|
Phase 2 | |
Terminated |
NCT04141917 -
Test-and-treat for Influenza in Homeless Shelters
|
Phase 4 | |
Recruiting |
NCT06017310 -
Respiferon Project
|
||
Enrolling by invitation |
NCT06188988 -
Viral Infections and Airway Microbiome in Young Children With Cystic Fibrosis
|
||
Completed |
NCT04141930 -
Pilot of Cohort of Households for Influenza Monitoring and Evaluation in Seattle
|
Phase 4 | |
Completed |
NCT05846360 -
The Technical and Operational Performance of the QuidelOrtho Savanna RVP4 Analyzer
|
||
Completed |
NCT04532411 -
COVID-19 Testing Sample Acquisition Throughput and Efficiency
|
||
Active, not recruiting |
NCT04258059 -
Wells and Enteric Disease Transmission Trial (WET - Trial)
|
N/A | |
Active, not recruiting |
NCT04482673 -
Vitamin D Supplementation in the Prevention and Mitigation of COVID-19 Infection
|
Phase 4 | |
Recruiting |
NCT05092607 -
Evaluation of the Detection Performance of the N Antigenemia of SARS-CoV-2 in the General Population for the Diagnosis and Screening of COVID-19
|
N/A | |
Recruiting |
NCT05913700 -
Effect of Respiratory Virus Infection on EmeRgencY Admission Study (EVERY Study)
|
||
Recruiting |
NCT04826991 -
Wells and Enteric Disease Transmission
|
N/A | |
Terminated |
NCT04664075 -
Predicting Severity and Disease Progression in Influenza-like Illness (Including COVID-19)
|