RECRUITING

Covid And Flu A/B 3 in 1 Combo Test

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This observational study aims to evaluate the diagnostic performance of an investigational Influenza A/B and COVID-19 test in patients presenting with signs and symptoms of respiratory infection. The main questions it aims to answer are: 1. What is the sensitivity and specificity of the investigational test compared with an FDA-cleared reference method for detection of Influenza A, Influenza B, and SARS-CoV-2 antigen. 2. What is the overall positive and negative percent agreement between the investigational test and the reference method? Participants will: 1. Provide a respiratory specimen (e.g., nasal or nasopharyngeal swab) for testing with the investigational device. 2. Provide an additional specimen for testing with the FDA-cleared reference method.

Official Title

Evaluation of iHealth COVID-19/Flu A&B Rapid Test for SARS-CoV-2 and Flu A&B Detection in Symptomatic Individuals

Quick Facts

Study Start:2024-11-12
Study Completion:2026-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT07190131

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:2 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Written informed consent obtained prior to study enrollment.
  2. * Male or female aged 2 years or older
  3. * Subject is currently exhibiting two or more symptoms associated with COVID-19 or influenza (such as, but not limited to, fever, chills, cough, shortness of breath or difficulty breathing, fatigue, new loss of taste or smell, sore throat, congestion or runny nose, nausea or vomiting or diarrhea) (and must present within 6 days of symptom onset- For Antigen assay only). Subject must still be exhibiting symptoms on the day of sample collection.
  1. * Subject who is 18 years of age (or the state's legal age of majority) or older and does not understand or is not able and willing to sign the study informed consent.
  2. * Subject has had seasonal influenza and/or the SARS-CoV-2 vaccine within the past 5 days.
  3. * Subject is not able to tolerate sample collection, or is not willing to contribute the required swab samples for testing or complete the study procedures.
  4. * Subject is currently undergoing antiviral treatment such as baloxavir marboxil (trade name Xofluza®), oseltamivir (Tamiflu®), zanamivir (Relenza®), and peramivir (Rapivab®).
  5. * Subjects currently undergoing treatment and/or within the past thirty (30) days with prescription medication to treat novel Coronavirus SARS-CoV-2 infection, which may include but is not limited to Remdesivir (Veklury), Paxlovid, molnupiravir or receiving convalescent plasma therapy for SARS-CoV-2.
  6. * Subjects who have taken Evusheld (tixagevimab/cilgavimab) within the last 90 days
  7. * Subjects who have had a nasal wash or aspirate as part of their standard of care treatment on day of study visit prior to the study sample collection.
  8. * Subjects who have had recent craniofacial injury or surgery, including to correct deviation of the nasal septum, within the previous six (6) months

Contacts and Locations

Study Locations (Sites)

iHealth Site 006
Birmingham, Alabama, 35242
United States
iHealth Site 021
Trussville, Alabama, 35173
United States
iHealth Site 017
Dublin, California, 94568
United States
iHealth Site 007
Huntington Park, California, 90255
United States
iHealth Site 008
Los Angeles, California, 90057
United States
iHealth Site 011
DeLand, Florida, 32720
United States
iHealth Site 013
Doral, Florida, 33122
United States
iHealth Site 004
Fort Lauderdale, Florida, 33308
United States
iHealth Site 005
Fort Lauderdale, Florida, 33312
United States
iHealth Site 014
Tamarac, Florida, 33321
United States
iHealth Site 009
Ammon, Idaho, 83406
United States
iHealth Site 012
Idaho Falls, Idaho, 83404
United States
iHealth Site 024
Smithfield, Pennsylvania, 15478
United States
iHealth Site 015
Simpsonville, South Carolina, 29681
United States
iHealth Site 016
Spartanburg, South Carolina, 29301
United States
iHealth Site 020
Chattanooga, Tennessee, 37412
United States
iHealth Site 003
Brownsville, Texas, 78520
United States
iHealth Site 002
Edinburg, Texas, 78539
United States

Collaborators and Investigators

Sponsor: iHealth Labs inc

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-11-12
Study Completion Date2026-01

Study Record Updates

Study Start Date2024-11-12
Study Completion Date2026-01

Terms related to this study

Additional Relevant MeSH Terms

  • COVID - 19
  • Influenza A
  • Influenza B