COVID - 19NCT07190131
Evaluation of COVID-19 and Flu A/B 3 in 1 Combo Rapid Test
An observational study of COVID - 19 and Influenza A, run by iHealth Labs inc at 15 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 2 years and older
- Conditions the study is for
- COVID - 19, Influenza A, Influenza B
- What is being tested?
- Investigational Flu A/B And Covid-19 Diagnostic Test
- How many people
- 588 participants
- Where
- 15 sitesin 2 countries
- Study dates
- 12 Nov 2024to 12 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Individuals with flu-like symptoms presenting to participating clinical sites
Who may be able to join
- Written informed consent obtained prior to study enrollment.
- Male or female aged 2 years or older
- 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.
Who cannot join
- 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.
- Subject has had seasonal influenza and/or the SARS-CoV-2 vaccine within the past 5 days.
- 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.
- Subject is currently undergoing antiviral treatment such as baloxavir marboxil (trade name Xofluza®), oseltamivir (Tamiflu®), zanamivir (Relenza®), and peramivir (Rapivab®).
- 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.
- Subjects who have taken Evusheld (tixagevimab/cilgavimab) within the last 90 days
- 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.
- Subjects who have had recent craniofacial injury or surgery, including to correct deviation of the nasal septum, within the previous six (6) months
Trial locations and contacts
15 sites in 2 countries.
15 sites in 2 countries
United States14 sites
iHealth Site 009
Ammon, Idaho, 83406
iHealth Site 006
Birmingham, Alabama, 35242
iHealth Site 003
Brownsville, Texas, 78520
iHealth Site 020
Chattanooga, Tennessee, 37412
iHealth Site 013
Doral, Florida, 33122
iHealth Site 017
Dublin, California, 94568
iHealth Site 002
Edinburg, Texas, 78539
iHealth Site 004
Fort Lauderdale, Florida, 33308
iHealth Site 005
Fort Lauderdale, Florida, 33312
iHealth Site 007
Huntington Park, California, 90255
iHealth Site 008
Los Angeles, California, 90057
iHealth Site 024
Smithfield, Pennsylvania, 15478
iHealth Site 014
Tamarac, Florida, 33321
iHealth Site 021
Trussville, Alabama, 35173
About this study
Official title: Evaluation of iHealth COVID-19/Flu A&B Rapid Test for SARS-CoV-2 and Flu A&B Detection in Symptomatic Individuals
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:
Read more
- 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.
- What is the overall positive and negative percent agreement between the investigational test and the reference method?
Participants will:
- Provide a respiratory specimen (e.g., nasal or nasopharyngeal swab) for testing with the investigational device.
- Provide an additional specimen for testing with the FDA-cleared reference method.
- Conditions
- COVID - 19, Influenza A, Influenza B
- Being tested
- Investigational Flu A/B And Covid-19 Diagnostic Test
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Investigational Flu A/B And Covid-19 Diagnostic TestDiagnostic test
A diagnostic test in lateral flow cassette format designed to detect Influenza A, Influenza B and SARS-CoV-2 from anterior nasal swab specimens.
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and Specificity of the Investigational Test for Detection of Influenza A, Influenza B and SARS-CoV-2 Compared to an FDA-Cleared Reference Method
Measured: Within approximately 5 days of specimen collection (time needed for both investigational and comparator test results)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2025
- Study start12 Nov 2024
- Primary completion12 Dec 2025
- Study completion12 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID - 19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 588 participants (actual)
Sponsor and investigators
- Lead sponsor
- iHealth Labs inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07190131
- Sponsor's protocol ID
- iH017
- Status last verified
- Jan 2026
- First submitted
- 22 Sep 2025
- Last updated
- 8 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of iHealth COVID-19/Flu A&B Rapid Test for SARS-CoV-2 and Flu A&B Detection in Symptomatic Individuals
- ClinicalTrials.gov ID
- NCT07190131
- Acronym / sponsor ID
- iH017
- Conditions
- COVID - 19, Influenza A, Influenza B
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 588 participants (actual)
- Lead sponsor
- iHealth Labs incIndustry (pharma, biotech, devices)
- Study start
- 12 Nov 2024 (actual)
- Primary completion
- 12 Dec 2025 (actual)
- Study completion
- 12 Dec 2025 (actual)
- First posted
- 24 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- What is the overall positive and negative percent agreement between the investigational test and the reference method?
Participants will:
- Provide a respiratory specimen (e.g., nasal or nasopharyngeal swab) for testing with the investigational device.
- Provide an additional specimen for testing with the FDA-cleared reference method.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Individuals with flu-like symptoms presenting to participating clinical sites
Key inclusion criteria (3 listed)
- Written informed consent obtained prior to study enrollment.
- Male or female aged 2 years or older
- 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.
Key exclusion criteria (8 listed)
- 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.
- Subject has had seasonal influenza and/or the SARS-CoV-2 vaccine within the past 5 days.
- 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.
- Subject is currently undergoing antiviral treatment such as baloxavir marboxil (trade name Xofluza®), oseltamivir (Tamiflu®), zanamivir (Relenza®), and peramivir (Rapivab®).
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Investigational Flu A/B And Covid-19 Diagnostic TestA diagnostic test in lateral flow cassette format designed to detect Influenza A, Influenza B and SARS-CoV-2 from anterior nasal swab specimens. | Diagnostic test | – |
Primary outcome
Sensitivity and Specificity of the Investigational Test for Detection of Influenza A, Influenza B and SARS-CoV-2 Compared to an FDA-Cleared Reference Method
Time frame: Within approximately 5 days of specimen collection (time needed for both investigational and comparator test results)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
15 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID - 19 and Influenza A, run by iHealth Labs inc at 15 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity and Specificity of the Investigational Test for Detection of Influenza A, Influenza B and SARS-CoV-2 Compared to an FDA-Cleared Reference Method (time frame: Within approximately 5 days of specimen collection (time needed for both investigational and comparator test results)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2026.