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NOWDx Test for the Detection of Antibodies to COVID-19
NCT04690413 · View on ClinicalTrials.gov ↗
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).
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04690413
The ClinicalTrials.gov registry entry for NCT04690413 describes a study currently listed as completed. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 129 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is NOWDiagnostics, which has 3 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04690413 reports 3 study locations spanning 3 distinct geographic areas — top geographies include Arizona, Florida, Tennessee. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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, Coronavirus, SARS-CoV-2. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04690413?
The interventions under investigation include: NOWDx COVID-19 Test (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04690413?
This trial is sponsored by NOWDiagnostics, which has 3 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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