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NCT04568356 · ClinicalTrials.gov registry record · NA
A Clinical Evaluation of COVID-19 Rapid Point of Care Antigen Tests
A NA study of SARS-CoV-2, sponsored by E25Bio.
- Completed
- Registry status
- NA
- Development phase
- 200
- Enrollment target
- 3
- Study locations
NCT04568356: Completed NA study of SARS-CoV-2, sponsored by E25Bio.
NCT04568356 is a NA study of SARS-CoV-2 that has completed, run by E25Bio. The registered enrollment target is 200 participants, below the 3,448-participant average among 34 other SARS-CoV-2 trials with a reported enrollment target (94% lower). The trial reports 3 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04568356, a NA study of SARS-CoV-2, has completed, sponsored by E25Bio.
- COMPLETED
- Registry status
- NA
- Development phase
- 200 participants
- Enrollment target
- 3
- Study locations
Study Summary
The current standard of care for diagnosis of Severe Acute Respiratory Syndrome associated Coronavirus -2 (SARS-CoV-2 ) infection involves sample collection to be prepared and measured via real time-polymerase chain reaction (RT-PCR). This process is often time consuming depending on the level of automation within the laboratory processing the samples. In many cases, sample turn-around times can take hours to several days. A rapid assay that does not require the sophisticated laboratory equipment and techniques could provide a significant advantage to the way practitioners screen and ultimately treat patients. Moreover, the collection of samples from the nasal nares should prove useful and less invasive. The study aims to validate the use of nasal swabs and also to validate the antigen test using nasal swabs.
Primary Outcome
Calculate the performance of the antigen test compared to PCR using nasopharyngeal swab samples
Conditions Studied
Interventions
- DIAGNOSTIC_TEST Direct Antigen Tests for COVID-19
Study Locations (3)
Florida
- JFK Medical Center - Miami
- Kendall Regional - Miami
- Aventura Hospital and Medical Center - Miami
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 200 participants |
| Start Date | 2020-04-24 |
| Est. Completion | 2020-09-24 |
| Phase | NA |
What the finished NCT04568356 record still lists
NCT04568356 is an interventional study that assigns participants to a tested intervention. The registered 200 participants enrollment target is mid-sized for trials with a published cap, below the 3,448-participant average among 34 other SARS-CoV-2 trials with a reported enrollment target (94% lower).
The record links to 1 condition, with SARS-CoV-2 appearing as the primary indexed condition, and to 1 intervention - of which Direct Antigen Tests for COVID-19 is the first listed.
NCT04568356 reports a single indexed study location in Florida.
Frequently Asked Questions
What is clinical trial NCT04568356 about?
NCT04568356 is a clinical study titled "A Clinical Evaluation of COVID-19 Rapid Point of Care Antigen Tests". The current standard of care for diagnosis of Severe Acute Respiratory Syndrome associated Coronavirus -2 (SARS-CoV-2 ) infection involves sample collection to be prepared and measured via real time-polymerase chain reaction (RT-PCR). This process is often time consuming depending on the level of au...
What is the current status of trial NCT04568356?
This trial is currently completed. It is a NA study. The enrollment target is 200 participants. The study started on 2020-04-24. Estimated completion is 2020-09-24.
What conditions does trial NCT04568356 study?
This clinical trial studies the following conditions: SARS-CoV-2.
What interventions are being tested in trial NCT04568356?
The interventions under investigation include: Direct Antigen Tests for COVID-19 (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT04568356?
This trial is sponsored by E25Bio, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04568356 being conducted?
This trial has 3 study locations across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for SARS-CoV-2
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04568356's enrollment target sits among peer trials
200 22nd of 34 higher than 13 of 34 other SARS-CoV-2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other SARS-CoV-2 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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