At least 30 children between 2 - 13 years of age for Coronavirus

N/A

Waitlist Available

Led By Enrique Villa, MD

Research Sponsored by BioTeke USA, LLC

Eligibility Criteria Checklist

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

Must have

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 48 hours

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a home COVID-19 test kit that people can use by swabbing their nose. It is designed for anyone aged 14 and older to use on their own, and for adults to use on children aged 2 to 13. The test works by using antibodies to detect the virus.

Eligible Conditions

Coronavirus

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 48 hours

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~48 hours

This trial's timeline: 3 weeks for screening, Varies for treatment, and 48 hours for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Negative Percent Agreement - Specificity

Positive Percent Agreement - Sensitivity

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Group I: Subjects 14 - 90 years of ageExperimental Treatment3 Interventions

The subject will self collect and test using the Bio-Self COVID-19 antigen home test. The standard of care test and the RT-PCR test samples will be collected by the study team.

Group II: At least 30 children between 2 - 13 years of ageExperimental Treatment3 Interventions

Subjects less than 14 years of age, where the Parent or legal guardian collects a sample from their child (e.g., ages 2-13) and performs the Bio-Self COVID-19 antigen home test. The standard of care test and the RT-PCR test samples will be collected by the study team.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Bio-Self COVID-19 Antigen Home Test

2022

N/A

~290

Standard of Care COVID-19 Test

2022

N/A

~290