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NCT04720794 · ClinicalTrials.gov registry record · NA
A Study To Evaluate The Performance of the Lucira Health All-In-One COVID-19 Test Kit vs Hologic Panther Fusion
A NA study of COVID-19 and Corona Virus Infection, sponsored by Lucira Health.
- Completed
- Registry status
- NA
- Development phase
- 101
- Enrollment target
- 1
- Study location
NCT04720794: Completed NA study of COVID-19 and Corona Virus Infection, sponsored by Lucira Health.
NCT04720794 is a NA study of COVID-19 and Corona Virus Infection that has completed, run by Lucira Health. The registered enrollment target is 101 participants, below the 38,465-participant average among 298 other COVID-19 trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04720794, a NA study of COVID-19 and Corona Virus Infection, has completed, sponsored by Lucira Health.
- COMPLETED
- Registry status
- NA
- Development phase
- 101 participants
- Enrollment target
- 1
- Study location
Study Summary
This Lucira COVID-19 All-In-One Test Kit performance study will be used to establish the performance of the Lucira COVID-19 All-In-One Test Kit as compared to a known high sensitivity RT-PCR molecular assay. The results of this study will be used to demonstrate the Lucira COVID-19 'swab to result in 30 minutes' test kit is similar in performance to known high sensitivity best-in-class molecular assays performed in high complexity labs. The results of this study will be combined with other studies the Sponsor has underway and will support a FDA Emergency Use Authorization (EUA) of the Lucira COVID-19 All-In-One Test Kit. This performance study will include nasal swabs self-collected by study subjects at community-based locations with trained medical staff. A subject's participation in this study will consist of one study visit and one collection event. The subject self-collects a nasal swab sample according to Lucira COVID-19 Test Kit instructions and runs test according to Quick Reference Instructions (QRI). Following the Lucira COVID-19 All-In-One Test Kit self-collection will be an additional swab collection for reference method testing. One (1) additional NS specimen will be collected either by the health care professional or self-collection, prepared in Transport Medium and sent to a reference laboratory.
Primary Outcome
Study prevalence of SARS-CoV-2 will be summarized by counts and grouped by age
Conditions Studied
Interventions
- DEVICE Lucira COVID-19 All-In-One test kit
Study Locations (1)
California
- Neeraj Kochhar Family Medicine - Los Gatos
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 101 participants |
| Start Date | 2020-09-25 |
| Est. Completion | 2020-10-20 |
| Phase | NA |
What the finished NCT04720794 record still lists
NCT04720794 is an interventional study that assigns participants to a tested intervention. The registered 101 participants enrollment target is mid-sized for trials with a published cap, below the 38,465-participant average among 298 other COVID-19 trials with a reported enrollment target (100% lower).
The record links to 3 conditions, with COVID-19 appearing as the primary indexed condition, and to 1 intervention - of which Lucira COVID-19 All-In-One test kit is the first listed.
NCT04720794 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT04720794 about?
NCT04720794 is a clinical study titled "A Study To Evaluate The Performance of the Lucira Health All-In-One COVID-19 Test Kit vs Hologic Panther Fusion". This Lucira COVID-19 All-In-One Test Kit performance study will be used to establish the performance of the Lucira COVID-19 All-In-One Test Kit as compared to a known high sensitivity RT-PCR molecular assay. The results of this study will be used to demonstrate the Lucira COVID-19 'swab to result in...
What is the current status of trial NCT04720794?
This trial is currently completed. It is a NA study. The enrollment target is 101 participants. The study started on 2020-09-25. Estimated completion is 2020-10-20.
What conditions does trial NCT04720794 study?
This clinical trial studies the following conditions: COVID-19, Corona Virus Infection, SARS (Severe Acute Respiratory Syndrome).
What interventions are being tested in trial NCT04720794?
The interventions under investigation include: Lucira COVID-19 All-In-One test kit (DEVICE).
Who is sponsoring clinical trial NCT04720794?
This trial is sponsored by Lucira Health, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04720794 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04720794's enrollment target sits among peer trials
101 200th of 298 higher than 99 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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