COVID-19 Clinical Trial
Official title:
Clinical Evaluation of the Panbio™ COVID-19/Flu A&B Panel to Support Home Use
This study is designed to demonstrate the performance and usability of the the Panbio™ COVID-19/Flu A&B Panel Self Test in the hands of patients/lay-users. Nasal swabs will be self-collected by subjects/lay-users who are symptomatic and suspected of viral respiratory infection. They will perform, read, and interpret the test result. The test is intended for nonprescription home use for qualitative detection of COVID-19, Influenza A antigen, and Influenza B antigen.
The total number of anterior nasal swabs collected from each consented Participant is two (2). Participants at least two (2) years of age meeting eligibility criteria will be enrolled. The order of nasal swab collection will be randomized according to the Participant ID as to which swab is used for Panbio™ COVID-19/Flu A&B Panel Self Test and which is to be eluted into VTM for comparator testing. Site staff should allow for a minimum 15 minute period between the 2 swabs to allow for normalization of the swabbing site. For Participants with an odd numbered Participant ID, the first swab collected will be used for Panbio™ COVID-19/Flu A&B Panel Self Test and the second swab collected will be eluted into VTM for comparator testing. For Participants with an even numbered Participant ID, the first swab collected will be eluted into VTM for comparator testing and the second swab collected will be used for Panbio™ COVID-19/Flu A&B Panel Self Test. Sample collection for the Self Test: Each Participant (lay user who will be a self-tester or caregiver) from whom informed consent has been obtained will be provided a single use test kit containing a Panbio™ COVID-19/Flu A&B Panel Self Test and a sterile nasal swab. The Participant will self-collect one (1) anterior nasal swab, perform the Panbio™ COVID- 19/Flu A&B Panel Self Test, then interpret and record the result. Parents of pediatric participants under the age of 14 or Legally Authorized Representatives of adult Participants unable to perform self-collection will collect one (1) anterior nasal swab from the Participant, perform the Panbio™ COVID-19/Flu A&B Panel Self Test, then interpret and record the result. To simulate a home environment testing will occur in a designated room/area that does not contain medical equipment. The designated room/area will at minimum contain a table/counter, chair and lamp for testing. The participant will be provided with the Instructions for Use prior to testing. Participants will not be able to observe other participants conducting testing. The Participant will follow Panbio instructions to insert the swab up to one inch first into the right nostril, to rotate/swirl the swab five (5) times to obtain sample, then remove and insert the same swab into the left nostril, repeating the rotate/swirl technique. After sample collection, Participants will test the sample on the Panbio™ COVID-19/Flu A&B Panel Self Test and interpret the results. Participants will be asked to document their result interpretation, and will pass the completed test to site staff, who will independently and separately document their interpretation of the result. Site staff will interpret the test immediately and at the same time photograph the test result. Site staff will be blinded to the test result recorded by the Participant. Participants/lay users, caregivers, and site staff will be blinded to a Participant's standard of care COVID-19 and/or Flu test results. Sample collection for the comparator: Site staff will collect one (1) anterior nasal swab from the Participant by inserting the swab 1-2 cm into one of the anterior nares. Staff will rotate the swab against the nasal mucosa for about 3 seconds and withdraw. Staff will repeat with the other anterior nare using the same swab, and vigorously elute the swab in Viral Transport Medium (VTM). VTM will be send to the central lab and be tested with reverse transcriptase - Polymerase Chain Reaction (RT-PCR). ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT06065033 -
Exercise Interventions in Post-acute Sequelae of Covid-19
|
N/A | |
| Completed |
NCT06267534 -
Mindfulness-based Mobile Applications Program
|
N/A | |
| Completed |
NCT05047601 -
A Study of a Potential Oral Treatment to Prevent COVID-19 in Adults Who Are Exposed to Household Member(s) With a Confirmed Symptomatic COVID-19 Infection
|
Phase 2/Phase 3 | |
| Recruiting |
NCT04481633 -
Efficacy of Pre-exposure Treatment With Hydroxy-Chloroquine on the Risk and Severity of COVID-19 Infection
|
N/A | |
| Recruiting |
NCT05323760 -
Functional Capacity in Patients Post Mild COVID-19
|
N/A | |
| Completed |
NCT04537949 -
A Trial Investigating the Safety and Effects of One BNT162 Vaccine Against COVID-19 in Healthy Adults
|
Phase 1/Phase 2 | |
| Completed |
NCT04612972 -
Efficacy, Safety and Immunogenicity of Inactivated SARS-CoV-2 Vaccines (Vero Cell) to Prevent COVID-19 in Healthy Adult Population In Peru Healthy Adult Population In Peru
|
Phase 3 | |
| Recruiting |
NCT05494424 -
Cognitive Rehabilitation in Post-COVID-19 Condition
|
N/A | |
| Active, not recruiting |
NCT06039449 -
A Study to Investigate the Prevention of COVID-19 withVYD222 in Adults With Immune Compromise and in Participants Aged 12 Years or Older Who Are at Risk of Exposure to SARS-CoV-2
|
Phase 3 | |
| Enrolling by invitation |
NCT05589376 -
You and Me Healthy
|
||
| Completed |
NCT05158816 -
Extracorporal Membrane Oxygenation for Critically Ill Patients With COVID-19
|
||
| Recruiting |
NCT04341506 -
Non-contact ECG Sensor System for COVID19
|
||
| Completed |
NCT04384445 -
Zofin (Organicell Flow) for Patients With COVID-19
|
Phase 1/Phase 2 | |
| Completed |
NCT04512079 -
FREEDOM COVID-19 Anticoagulation Strategy
|
Phase 4 | |
| Active, not recruiting |
NCT05975060 -
A Study to Evaluate the Safety and Immunogenicity of an (Omicron Subvariant) COVID-19 Vaccine Booster Dose in Previously Vaccinated Participants and Unvaccinated Participants.
|
Phase 2/Phase 3 | |
| Active, not recruiting |
NCT05542862 -
Booster Study of SpikoGen COVID-19 Vaccine
|
Phase 3 | |
| Terminated |
NCT05487040 -
A Study to Measure the Amount of Study Medicine in Blood in Adult Participants With COVID-19 and Severe Kidney Disease
|
Phase 1 | |
| Withdrawn |
NCT05621967 -
Phonation Therapy to Improve Symptoms and Lung Physiology in Patients Referred for Pulmonary Rehabilitation
|
N/A | |
| Terminated |
NCT04498273 -
COVID-19 Positive Outpatient Thrombosis Prevention in Adults Aged 40-80
|
Phase 3 | |
| Active, not recruiting |
NCT06033560 -
The Effect of Non-invasive Respiratory Support on Outcome and Its Risks in Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-COV-2)-Related Hypoxemic Respiratory Failure
|