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NCT05403346 · ClinicalTrials.gov registry record
Clinical Evaluation of a COVID-19 Antigen Self-Test (CoviDx™)
A clinical trial, sponsored by Lumos Diagnostics.
- Terminated
- Registry status
- 45
- Enrollment target
NCT05403346: Clinical Trial study, sponsored by Lumos Diagnostics.
NCT05403346 is a clinical trial that was terminated before completion, run by Lumos Diagnostics. The registered enrollment target is 45 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05403346 was terminated before completion, sponsored by Lumos Diagnostics.
- TERMINATED
- Registry status
- 45 participants
- Enrollment target
Study Summary
Prospective study that will evaluate the clinical agreement of the CoviDx™ Self test compared to SARS-CoV-2 RT-PCR.
Primary Outcome
Evaluate the performance (positive percent agreement (PPA) and negative percent agreement (NPA)) of the CoviDx™ COVID-19 Antigen Self-Test for the detection of SARS-CoV-2 virus antigen in anterior nasal swab (NS) samples collected by lay users compared to results obtained from by a high-sensitive SARS-CoV-2 RT-PCR granted Emergency Use Authorization (EUA) by the FDA (comparator test).
Interventions
- DEVICE CoviDx™ Covid-19 Antigen Self-Test
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 45 participants |
| Start Date | 2022-05-17 |
| Est. Completion | 2022-10-31 |
Why NCT05403346 stopped before completion
NCT05403346 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 45 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which CoviDx™ Covid-19 Antigen Self-Test is the first listed.
NCT05403346 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05403346 about?
NCT05403346 is a clinical study titled "Clinical Evaluation of a COVID-19 Antigen Self-Test (CoviDx™)". Prospective study that will evaluate the clinical agreement of the CoviDx™ Self test compared to SARS-CoV-2 RT-PCR.
What is the current status of trial NCT05403346?
This trial is currently terminated. The enrollment target is 45 participants. The study started on 2022-05-17. Estimated completion is 2022-10-31.
What interventions are being tested in trial NCT05403346?
The interventions under investigation include: CoviDx™ Covid-19 Antigen Self-Test (DEVICE).
Who is sponsoring clinical trial NCT05403346?
This trial is sponsored by Lumos Diagnostics, which has 6 total clinical trials registered on ClinicalTrials.gov.
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