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Metrix Test for COVID-19 and Flu

N/A

Recruiting

Led By Qin Yang, PhD

Research Sponsored by Aptitude Medical Systems

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participant is currently exhibiting fever, or one or more symptoms associated with COVID-19 and/or influenza and must still be exhibiting symptoms on the day of sample collection.

Must not have

Participant does not understand and/or is not able and willing to sign the study informed consent and/or assent.

Participant is currently undergoing antiviral treatment such as baloxavir marboxil, oseltamivir, zanamivir, and peramivir.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 45 minutes

Awards & highlights

No Placebo-Only Group

Summary

This trial will evaluate the Metrix COVID/Flu Test for use in home testing. The study will be conducted in simulated home environments and urgent care facilities. The purpose of the trial is to validate

Who is the study for?

This trial is for individuals who can participate in a study to test the Metrix COVID/Flu Test, which detects SARS-CoV-2 and Influenza A/B. Participants will use the test in simulated home environments within or near clinical settings like urgent care facilities.

What is being tested?

The trial is evaluating the Metrix COVID/Flu Test's accuracy for detecting SARS-CoV-2, Flu A, and Flu B from swab or saliva samples. The testing environment mimics home use but takes place near active clinical sites across multiple U.S. locations and potentially abroad.

What are the potential side effects?

Since this trial involves diagnostic testing rather than medication or vaccines, traditional side effects are not applicable. However, discomfort from swab collection may occur.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I currently have a fever or symptoms like those of COVID-19 or the flu.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I understand and am willing to sign the study consent form.

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I am currently on antiviral medication.

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I am currently taking or have recently taken medication for COVID-19.

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I cannot read or understand English.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 45 minutes

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~45 minutes

This trial's timeline: 3 weeks for screening, Varies for treatment, and 45 minutes for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Qualitative detection of RNA from SARS-CoV-2, Influenza A, and Influenza B

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: OTC StudyExperimental Treatment1 Intervention

This OTC study will take place in simulated home environments which will be set up within or near clinical settings (e.g., urgent care facilities). The study will enroll symptomatic subjects only. Candidate samples will be self-collected by participants (or collected by a guardian for participants under the age of 14 years) and comparator samples will be collected by a healthcare practitioner with informed consent and Institutional Review Board (IRB) approval. Each sample will be coded for confidentiality.

0 / 5Eligibility criteria met