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RECRUITING

Prospective Clinical Evaluation of the BioFire Emerging Coronavirus Panel for the Detection of COVID-19 and Other Coronaviruses

NCT07221097 · View on ClinicalTrials.gov ↗

Study Summary

The Biomedical Advanced Research and Development Authority (BARDA) has contracted BioFire Defense (BFDf) to develop the BioFire Emerging Coronavirus (ECoV) Panel, a nucleic acid test capable of detecting coronaviruses from nasopharyngeal swab (NPS) in transport medium. This study aims to evaluate the diagnostic accuracy of the assays comprising the BioFire ECoV Panel. It is hypothesized that the BioFire ECoV Panel assays will be highly sensitive and specific for the detection of the coronaviruses included on the panel.

Interventions

  • DEVICE Investigational IVD for coronaviruses

Study Locations (6)

California

  • Children's Hospital Los Angeles — Los Angeles

District of Columbia

  • George Washington University — Washington D.C.

Florida

  • Tampa General Hospital — Tampa

Georgia

  • Emory University Hospital — Atlanta

North Carolina

  • Wake Forest University Health Sciences — Winston-Salem

Texas

  • University of Texas Medical Branch — Galveston

Trial Details

FieldValue
Enrollment Target 1,500 participants
Start Date 2025-09-29
Est. Completion 2026-08

Sponsor

BioFire Defense

29 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT07221097

The ClinicalTrials.gov registry entry for NCT07221097 describes a study currently listed as recruiting. It is categorized as an unspecified phase, 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 1,500 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is BioFire Defense, which has 29 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 Coronavirus appearing as the primary indexed condition, and to 1 intervention — of which Investigational IVD for coronaviruses 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: NCT07221097 reports 6 study locations spanning 6 distinct geographic areas — top geographies include California, District of Columbia, Florida. 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 NCT07221097 about?

NCT07221097 is a clinical study titled "Prospective Clinical Evaluation of the BioFire Emerging Coronavirus Panel for the Detection of COVID-19 and Other Coronaviruses". The Biomedical Advanced Research and Development Authority (BARDA) has contracted BioFire Defense (BFDf) to develop the BioFire Emerging Coronavirus (ECoV) Panel, a nucleic acid test capable of detecting coronaviruses from nasopharyngeal swab (NPS) in transport medium. This study aims to evaluate t...

What is the current status of trial NCT07221097?

This trial is currently recruiting. The enrollment target is 1,500 participants. The study started on 2025-09-29. Estimated completion is 2026-08.

What conditions does trial NCT07221097 study?

This clinical trial studies the following conditions: Coronavirus, COVID, Respiratory Infection. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT07221097?

The interventions under investigation include: Investigational IVD for coronaviruses (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT07221097?

This trial is sponsored by BioFire Defense, which has 29 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT07221097 being conducted?

This trial has 6 study locations across California, District of Columbia, Florida, Georgia, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial