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NCT06744660 · ClinicalTrials.gov registry record · NA
Clinical Validation of the Aptitude Medical Systems Metrix COVID-19 Test
A NA study of COVID-19 and COVID, sponsored by Aptitude Medical Systems.
- Recruiting
- Registry status
- NA
- Development phase
- 1,000
- Enrollment target
- 3
- Study locations
NCT06744660: Recruiting NA study of COVID-19 and COVID, sponsored by Aptitude Medical Systems.
NCT06744660 is a NA study of COVID-19 and COVID that is actively recruiting participants, run by Aptitude Medical Systems. The registered enrollment target is 1,000 participants, below the 38,462-participant average among 298 other COVID-19 trials with a reported enrollment target (97% lower). The trial reports 3 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06744660, a NA study of COVID-19 and COVID, is actively recruiting participants, sponsored by Aptitude Medical Systems.
- RECRUITING
- Registry status
- NA
- Development phase
- 1,000 participants
- Enrollment target
- 3
- Study locations
Study Summary
The Metrix COVID Test will be evaluated for use in Point-of-Care and Non-Laboratory settings in a home testing environment utilizing the clinical study design described herein. The study will take place in simulated home environments which will be set up within or near active clinical settings (e.g., urgent care facilities). This will be a prospective study conducted at three or more investigational sites located within the United States for the clinical validation of the Metrix COVID Test for the detection of SARS-CoV-2 AN swab samples. Additional sites may be added to the study in order to meet minimum subject/sample enrollment requirements and geographic prevalence of respiratory virus infections. Comparator testing will be performed to determine the infection status of each sample for comparison to results generated by the candidate test. The primary comparator for the study will be an FDA-cleared assay for the detection of SARS-CoV-2.
Primary Outcome
Qualitative detection of RNA from SARS-CoV-2 in unprocessed AN swab samples. Primary objective of this study is to evaluate the performance (positive percent agreement, negative percent agreement and 95% confidence intervals for upper and lower bounds) of the Metrix COVID/Flu Test for the qualitative detection of SARS-CoV-2 viral RNA using AN swab samples. Comparator testing will be performed to determine the status of each sample for comparison to results produced by the candidate test. Compara
Interventions
- DIAGNOSTIC_TEST Aptitude Medical Systems Metrix COVID Test
Study Locations (3)
Alabama
- AFC Montclair - Birmingham
- AFC Madison - Madison
Louisiana
- PPU Mid City - Baton Rouge
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,000 participants |
| Start Date | 2024-10-17 |
| Est. Completion | 2025-12-01 |
| Phase | NA |
What NCT06744660 shows while recruiting
NCT06744660 is an interventional study that assigns participants to a tested intervention. Its 1,000 participants enrollment target places it among the larger protocols in the corpus, below the 38,462-participant average among 298 other COVID-19 trials with a reported enrollment target (97% lower).
The record links to 2 conditions, with COVID-19 appearing as the primary indexed condition, and to 1 intervention - of which Aptitude Medical Systems Metrix COVID Test is the first listed.
NCT06744660 reports a single indexed study location in Alabama, Louisiana.
Frequently Asked Questions
What is clinical trial NCT06744660 about?
NCT06744660 is a clinical study titled "Clinical Validation of the Aptitude Medical Systems Metrix COVID-19 Test". The Metrix COVID Test will be evaluated for use in Point-of-Care and Non-Laboratory settings in a home testing environment utilizing the clinical study design described herein. The study will take place in simulated home environments which will be set up within or near active clinical settings (e.g....
What is the current status of trial NCT06744660?
This trial is currently recruiting. It is a NA study. The enrollment target is 1,000 participants. The study started on 2024-10-17. Estimated completion is 2025-12-01.
What conditions does trial NCT06744660 study?
This clinical trial studies the following conditions: COVID-19, COVID.
What interventions are being tested in trial NCT06744660?
The interventions under investigation include: Aptitude Medical Systems Metrix COVID Test (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT06744660?
This trial is sponsored by Aptitude Medical Systems, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06744660 being conducted?
This trial has 3 study locations across Alabama, Louisiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06744660's enrollment target sits among peer trials
1,000 71st of 298 higher than 222 of 298 other COVID-19 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other COVID-19 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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