Home use of COVID-19 antigen testing and data reporting
Community Study to Evaluate the Performance of COVID-19 Frequent Antigen Testing at Home Through Digital Health Reporting
This study tests whether home COVID-19 tests can accurately identify contagious people who don't have symptoms by having participants test themselves weekly for eight days if they get a positive result.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 1000 (estimated) |
| Ages | 12 Years and up |
| Sex | All |
| Sponsor | IDX20 Inc Industry-sponsored |
| Locations | 1 site (Chelsea, Massachusetts) |
| Trial ID | NCT05884515 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of home-based rapid diagnostic tests (RDTs) for COVID-19 in asymptomatic individuals. Participants will undergo weekly antigen testing and follow-up RT-PCR testing for eight days if a positive result is obtained. The goal is to establish a monitoring protocol for asymptomatic cases and assess the reliability of these tests in identifying contagious individuals. The study will take place at three sites within the same geographical area, focusing on the collection and analysis of test results over a four-month period.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals aged 12 and older who are asymptomatic and not critically ill.
Not a fit: Patients who are critically ill or under 12 years of age may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could streamline COVID-19 testing and improve monitoring of asymptomatic cases, potentially reducing transmission rates.
How similar studies have performed: Previous studies have indicated the effectiveness of rapid diagnostic tests in monitoring COVID-19, suggesting that this approach has potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * older than 12 years of age Exclusion Criteria: * critical ill
Where this trial is running
Chelsea, Massachusetts
- Chelsea Housing Authority — Chelsea, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Irene Bosch, PhD — IDX20 Inc
- Study coordinator: Irene Bosch, PhD
- Email: ibosch@idx20.us
- Phone: 6176861249
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.