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NCT04690413 · ClinicalTrials.gov registry record · NA
NOWDx Test for the Detection of Antibodies to COVID-19
A NA study of COVID-19 and SARS-CoV-2, sponsored by NOWDiagnostics.
- Completed
- Registry status
- NA
- Development phase
- 129
- Enrollment target
- 3
- Study locations
NCT04690413: Completed NA study of COVID-19 and SARS-CoV-2, sponsored by NOWDiagnostics.
NCT04690413 is a NA study of COVID-19 and SARS-CoV-2 that has completed, run by NOWDiagnostics. The registered enrollment target is 129 participants, below the 38,465-participant average among 298 other COVID-19 trials with a reported enrollment target (100% lower). The trial reports 3 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04690413, a NA study of COVID-19 and SARS-CoV-2, has completed, sponsored by NOWDiagnostics.
- COMPLETED
- Registry status
- NA
- Development phase
- 129 participants
- Enrollment target
- 3
- Study locations
Study Summary
This study is designed to compare the performance of the NOWDx COVID-19 Test to an emergency use authorized PCR test result. The intent is to show the rapid test device is comparable to a currently marketed device. The NOWDx COVID-19 Test is an in vitro lateral flow immunoassay intended for qualitative detection of total antibodies to SARS-CoV-2 in human whole blood (venous and fingerstick).
Primary Outcome
Calculate positive percent agreement (PPA) and negative percent agreement (NPA) between NOWDx COVID-19 Test and emergency use authorized or FDA cleared COVID-19 PCR Test.
Conditions Studied
Interventions
- DEVICE NOWDx COVID-19 Test
Study Locations (3)
Arizona
- Del Sol Research Management, LLC - Tucson
Florida
- Comprehensive Clinical Research, LLC - West Palm Beach
Tennessee
- Clinical Research Solutions, LLC - Jackson
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 129 participants |
| Start Date | 2020-09-01 |
| Est. Completion | 2020-12-31 |
| Phase | NA |
What the finished NCT04690413 record still lists
NCT04690413 is an interventional study that assigns participants to a tested intervention. The registered 129 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 NOWDx COVID-19 Test is the first listed.
NCT04690413 reports a single indexed study location in Arizona, Florida, Tennessee.
Frequently Asked Questions
What is clinical trial NCT04690413 about?
NCT04690413 is a clinical study titled "NOWDx Test for the Detection of Antibodies to COVID-19". This study is designed to compare the performance of the NOWDx COVID-19 Test to an emergency use authorized PCR test result. The intent is to show the rapid test device is comparable to a currently marketed device. The NOWDx COVID-19 Test is an in vitro lateral flow immunoassay intended for qualitat...
What is the current status of trial NCT04690413?
This trial is currently completed. It is a NA study. The enrollment target is 129 participants. The study started on 2020-09-01. Estimated completion is 2020-12-31.
What conditions does trial NCT04690413 study?
This clinical trial studies the following conditions: COVID-19, SARS-CoV-2, Coronavirus.
What interventions are being tested in trial NCT04690413?
The interventions under investigation include: NOWDx COVID-19 Test (DEVICE).
Who is sponsoring clinical trial NCT04690413?
This trial is sponsored by NOWDiagnostics, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04690413 being conducted?
This trial has 3 study locations across Arizona, Florida, Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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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 NCT04690413's enrollment target sits among peer trials
129 185th of 298 higher than 113 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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