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Virus Test

Subject 14-65+ years of age for COVID-19

N/A
Waitlist Available
Led By Jason Liggett, PhD
Research Sponsored by EDP Biotech
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Lay subjects greater than 2 years old that do not know their current COVID-19 status and can complete the consent/assent process in both written and spoken English may be included in the study.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months
Awards & highlights

Study Summary

This trial looked at the accuracy of a rapid antigen test for diagnosing SARS-CoV-2.

Eligible Conditions
  • COVID-19
  • Coronavirus

Eligibility Criteria

Inclusion Criteria

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

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Negative Percent Agreement
Positive Percent Agreement
Secondary outcome measures
Detection of Asymptomatic Positives

Trial Design

2Treatment groups
Experimental Treatment
Group I: Subject 14-65+ years of ageExperimental Treatment2 Interventions
Participants will have a nasopharyngeal swab sample collected by trained study site personnel for testing on a high sensitivity EUA SARS-CoV-2 RT-PCR assay to compare the result to the result of the iCura SARS-CoV-2 Antigen Rapid Home Test. The participant will then self-collect or, if both are over 18, collect from another study participant an anterior nasal swab sample and test using the iCura SARS-CoV-2 Antigen Rapid Home Test.
Group II: At least 30 children between 2 and 13 years of ageExperimental Treatment2 Interventions
Participants 2-13 years of age will have a nasopharyngeal swab sample collected by trained study site personnel for testing on a high sensitivity EUA SARS-CoV-2 RT-PCR assay to compare the result to the result of the iCura SARS-CoV-2 Antigen Rapid Home Test. The parent or legal guardian of the child will collect an anterior nasal swab sample from the child and perform the iCura SARS-CoV-2 Antigen Rapid Home Test.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
iCura COVID-19 Antigen Rapid Home Test
2022
N/A
~440
RT-PCR Test
2022
N/A
~1600

Find a Location

Who is running the clinical trial?

EDP BiotechLead Sponsor
3 Previous Clinical Trials
1,308 Total Patients Enrolled
3 Trials studying COVID-19
1,308 Patients Enrolled for COVID-19
iCura Diagnostics, LLCUNKNOWN
New Day DiagnosticsLead Sponsor
3 Previous Clinical Trials
1,308 Total Patients Enrolled
3 Trials studying COVID-19
1,308 Patients Enrolled for COVID-19

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
Journal of AutoimmunityJournal
The Epidemiology and Pathogenesis of Coronavirus Disease (COVID-19) Outbreak
Rothan, Hussin A., and Siddappa N. Byrareddy. 2020. “The Epidemiology and Pathogenesis of Coronavirus Disease (COVID-19) Outbreak”. Journal of Autoimmunity. Elsevier BV. doi:10.1016/j.jaut.2020.102433.
International Journal of Antimicrobial AgentsJournal
Severe Acute Respiratory Syndrome Coronavirus 2 (sars-cov-2) and Coronavirus Disease-2019 (COVID-19): The Epidemic and the Challenges
Lai, Chih-Cheng, Tzu-Ping Shih, Wen-Chien Ko, Hung-Jen Tang, and Po-Ren Hsueh. 2020. “Severe Acute Respiratory Syndrome Coronavirus 2 (sars-cov-2) and Coronavirus Disease-2019 (COVID-19): The Epidemic and the Challenges”. International Journal of Antimicrobial Agents. Elsevier BV. doi:10.1016/j.ijantimicag.2020.105924.
Military Medical ResearchJournal
The Origin, Transmission and Clinical Therapies on Coronavirus Disease 2019 (COVID-19) Outbreak – an Update on the Status
Guo, Yan-Rong, Qing-Dong Cao, Zhong-Si Hong, Yuan-Yang Tan, Shou-Deng Chen, Hong-Jun Jin, Kai-Sen Tan, De-Yun Wang, and Yan Yan. 2020. “The Origin, Transmission and Clinical Therapies on Coronavirus Disease 2019 (COVID-19) Outbreak – an Update on the Status”. Military Medical Research. Springer Science and Business Media LLC. doi:10.1186/s40779-020-00240-0.
clinicaltrials.govStudy
COVID-19 iCura SARS-CoV-2 Ag OTC: Clinical Evaluation
Jason Liggett 2022. "COVID-19 iCura SARS-CoV-2 Ag OTC: Clinical Evaluation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05555030.
~37 spots leftby Apr 2025
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