[Trial of device that is not approved or cleared by the U.S. FDA]

March 13, 2026 updated by: [Redacted]
Prospective clinical study conducted at three or more geographically diverse sites (with a simulated home environment) in the United States for the clinical validation of the NowFuture Digital Flu / COVID Test. Results from the investigational test will be compared to results from a 510(k) cleared 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. The secondary objective is to evaluate the usability of the investigational test and the user comprehension of the investigational test lay user instructions when performed by the lay users.

Study Overview

Status

Withheld

Conditions

Intervention / Treatment

Phase

  • Not Applicable

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.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Study participants
Participants self-collecting and testing the device themselves or collecting a sample and performing the testing on another participant
Diagnostic test: Diagnostic test for SARS-CoV-2, influenza A and influenza B
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical performance
Time Frame: The duration from enrollment to ending participation is one day. Each test session is estimated to last 60 minutes and conclude following test and comparator sample collection and completion of participant questionnaire.
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 and compared to results from a 510(k) cleared highly sensitive reverse transcriptase polymerase chain reaction (RT-PCR) test for SARS-CoV-2, influenza A and influenza B. The primary outcome of the study requires a minimum of; 50 SARS-CoV-2 positive samples, 50 Influenza A positive samples, 30 Influenza B positive samples and 500 negative samples by comparator. Study must be performed within a US Flu season, i.e. October to April of any given year.
The duration from enrollment to ending participation is one day. Each test session is estimated to last 60 minutes and conclude following test and comparator sample collection and completion of participant questionnaire.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

[Redacted]

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 Major Dates

Study Start

February 1, 2026

Primary Completion

March 1, 2027

Study Completion

May 1, 2027

Study Registration Dates

First Submitted

January 29, 2026

First Submitted That Met QC Criteria

February 5, 2026

First Posted (Actual)

February 10, 2026

Study Record Updates

Last Update Posted (Actual)

March 17, 2026

Last Update Submitted That Met QC Criteria

March 13, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLN-0019
  • 75A50125C00003 (Other Grant/Funding Number: Biomedical Advanced Research and Development Authority (BARDA))

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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