SARS CoV 2 InfectionNCT07743970
Clinical Validation of the NowFuture Digital Flu / COVID Test in Anterior Nasal Samples for Over-the-Counter (OTC) Use in Australia
A study testing Diagnostic test for SARS-CoV-2, influenza A and influenza B in people with SARS CoV 2 Infection and Influenza A Virus Infection, run by Biocrucible Ltd at 3 sites in Australia.
Trial summary
Prospective clinical study conducted at three sites (with a simulated home environment) in Australia for the clinical validation of the NowFuture Digital Flu / COVID Test. Results from the investigational test will be compared to results from a highly sensitive reverse transcriptase polymerase chain reaction (RT-PCR)… Read more about this study
- Who is it for?
- Ages 2 years and olderHealthy volunteers can take part
- Conditions the study is for
- SARS CoV 2 Infection, Influenza A Virus Infection, Influenza B Virus Infection
- What is being tested?
- Diagnostic test for SARS-CoV-2, influenza A and influenza B
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 3 sitesAustralia
- Study dates
- 17 Aug 2026to Apr 2027
- Phase
- Interventional
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
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Written informed consent obtained prior to study enrollment.
- Male or female aged 2 years of age and older.
- Participant is currently exhibiting at least one symptom (i.e. symptomatic) associated with COVID-19 or influenza (such as, but not limited to, fever, headache, 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 (equates to 5 DPSO). Subject must still be exhibiting symptom(s) on the day of sample collection.
Who cannot join
- Participant or participant's legally acceptable representative (for minors) 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.
- Participant who has had a positive SARS-CoV-2, Influenza A and/or Influenza B result within the past 30 days.
- Participant has had seasonal influenza vaccine such as the FluMist/FluMist Quadrivalent live intranasal influenza vaccine and/or the SARS-CoV-2 vaccine within the past 5 days.
- Participant is not able to tolerate sample collection or is not willing to contribute the required swab samples for testing or complete the study procedures.
- Participant is currently undergoing antiviral treatment such as baloxavir marboxil (Xofluza), oseltamivir (Tamiflu®), zanamivir (Relenza®), and peramivir (Rapivab®).
- Participant currently undergoing treatment and/or has undergone treatment within the past thirty (30) days with prescription medication to treat 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.
- Participant who has 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.
- Participant who has had recent craniofacial injury or surgery, including to correct deviation of the nasal septum, within the previous six (6) months.
Trial locations and contacts
3 sites in 1 country.
Australia3 sites
Paratus Western Sydney
Blacktown, New South Wales, 2148
Brecken Health
Bunbury, Western Australia, 6230
Clinical Trials Institute Torquay
Torquay, Victoria, 3228
About this study
Prospective clinical study conducted at three sites (with a simulated home environment) in Australia for the clinical validation of the NowFuture Digital Flu / COVID Test. Results from the investigational test will be compared to results from a highly sensitive reverse transcriptase polymerase chain reaction (RT-PCR) test for SARS-CoV-2, Influenza A and Influenza B. The primary objective of this study is to evaluate the clinical performance (positive percent agreement, negative percent agreement and 95% confidence intervals for upper and lower bounds) of the NowFuture Digital Flu / COVID Test for the qualitative detection and differentiation of SARS-CoV-2 nucleocapsid antigen, Influenza A and Influenza B nucleoproteins antigens using AN swab samples collected and processed in the test by lay users.
- Being tested
- Diagnostic test for SARS-CoV-2, influenza A and influenza B
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diagnostic test for SARS-CoV-2, influenza A and influenza BDiagnostic test
Participants will test themselves or another participant for SARS-CoV-2, influenza A and influenza B. Participants will observe the test result displayed on the device. Participants will be advised to not use investigational test result for diagnostics purposes.
| Study group | Role | What they receive |
|---|---|---|
| Study participants | Experimental | Participants self-collecting and testing the device themselves or collecting a sample and performing the testing on another participant Receives: Diagnostic Test: Diagnostic test for SARS-CoV-2, influenza A and influenza B |
What is being measured
The primary outcome is the main question the study is designed to answer.
Investigational Test Result
Investigational Test Result determined by the participant using the NowFuture Digital Flu / COVID Test under the test session. Participant will perform test to completion, and determine result as either of the following:
- Negative
- Positive to SARS-CoV-2 and/or influenza A and/or influenza B
- Invalid
- Test error
Measured: 60 minutes
Comparator Test Result
Study staff will collect anterior nasal swab sample from participant. Sample will be stored and transported to a reference laboratory for testing using the an RT-PCR test method. The test will record one of the following results, to be compared to the investigational test result:
- Negative
- Positive to SARS-CoV-2 and/or influenza A and/or influenza B
- Invalid
Measured: 14 days from sample collection to testing in a reference laboratory
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2026
- Study start17 Aug 2026
- Primary completionOct 2026 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SARS CoV 2 InfectionStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Biocrucible Ltd
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07743970
- Sponsor's protocol ID
- CLN-0020
- Other IDs
- 75A50125C00003
- Status last verified
- Oct 2026
- First submitted
- 26 Jul 2026
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No