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OTC Study for 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.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 45 minutes

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

Select...

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

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

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 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Aptitude Medical SystemsLead Sponsor

Biomedical Advanced Research and Development AuthorityFED

82 Previous Clinical Trials

908,757 Total Patients Enrolled

Qin Yang, PhDPrincipal InvestigatorAptitude Medical Systems

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any available openings for patients to participate in this study?

"Indeed, according to the details available on clinicaltrials.gov, this trial is actively seeking eligible participants. The initial posting of the study was made on November 20th, 2023 and it underwent its most recent update on January 2nd, 2024."

Answered by AI

What is the uppermost limit for participant enrollment in this research endeavor?

"Indeed, as per the information available on clinicaltrials.gov, this trial is currently seeking eligible participants. The initial posting of the trial occurred on November 20th, 2023 and was last modified on January 2nd, 2024. A total of three sites are enrolling approximately 1000 individuals for this study."

Answered by AI