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NCT04750629 · ClinicalTrials.gov registry record
Clinical Evaluation of a Point-of-Care (POC), COVID-19 Rapid Antigen Test (CoviDx™)
A clinical trial of COVID-19 and SARS-CoV-2, sponsored by Lumos Diagnostics.
- Completed
- Registry status
- 140
- Enrollment target
- 2
- Study locations
NCT04750629: Completed study of COVID-19 and SARS-CoV-2, sponsored by Lumos Diagnostics.
NCT04750629 is a study of COVID-19 and SARS-CoV-2 that has completed, run by Lumos Diagnostics. The registered enrollment target is 140 participants, below the 38,464-participant average among 298 other COVID-19 trials with a reported enrollment target (100% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04750629, a study of COVID-19 and SARS-CoV-2, has completed, sponsored by Lumos Diagnostics.
- COMPLETED
- Registry status
- 140 participants
- Enrollment target
- 2
- Study locations
Study Summary
Prospective study that will evaluate the clinical agreement of the CoviDx™ Rapid Antigen test compared to SARS-CoV-2 RT-PCR.
Primary Outcome
The primary outcome is the presence of SARS-CoV-2 antigen in nasal swab as compared to confirmatory diagnosis SARS-CoV-2 as determined by a high-sensitive SARS-CoV-2 RT-PCR granted Emergency Use Authorization (EUA) by the FDA
Conditions Studied
Interventions
- DEVICE POC CoviDx™ Rapid Antigen Test
Study Locations (2)
Florida
- Doral Medical Research - Hialeah
- Comprehensive Clinical Research - West Palm Beach
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 140 participants |
| Start Date | 2021-02-08 |
| Est. Completion | 2021-05-14 |
What the finished NCT04750629 record still lists
NCT04750629 is an observational study that tracks outcomes without assigning an intervention. The registered 140 participants enrollment target is mid-sized for trials with a published cap, below the 38,464-participant average among 298 other COVID-19 trials with a reported enrollment target (100% lower).
The record links to 2 conditions, with COVID-19 appearing as the primary indexed condition, and to 1 intervention - of which POC CoviDx™ Rapid Antigen Test is the first listed.
NCT04750629 reports a single indexed study location in Florida.
Frequently Asked Questions
What is clinical trial NCT04750629 about?
NCT04750629 is a clinical study titled "Clinical Evaluation of a Point-of-Care (POC), COVID-19 Rapid Antigen Test (CoviDx™)". Prospective study that will evaluate the clinical agreement of the CoviDx™ Rapid Antigen test compared to SARS-CoV-2 RT-PCR.
What is the current status of trial NCT04750629?
This trial is currently completed. The enrollment target is 140 participants. The study started on 2021-02-08. Estimated completion is 2021-05-14.
What conditions does trial NCT04750629 study?
This clinical trial studies the following conditions: COVID-19, SARS-CoV-2.
What interventions are being tested in trial NCT04750629?
The interventions under investigation include: POC CoviDx™ Rapid Antigen Test (DEVICE).
Who is sponsoring clinical trial NCT04750629?
This trial is sponsored by Lumos Diagnostics, which has 6 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04750629 being conducted?
This trial has 2 study locations across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04750629's enrollment target sits among peer trials
140 181st of 298 higher than 117 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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