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NCT07221097 · ClinicalTrials.gov registry record

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

A clinical trial of Coronavirus and COVID, sponsored by BioFire Defense.

Recruiting
Registry status
1,500
Enrollment target
6
Study locations

NCT07221097: Recruiting study of Coronavirus and COVID, sponsored by BioFire Defense.

NCT07221097 is a study of Coronavirus and COVID that is actively recruiting participants, run by BioFire Defense. The registered enrollment target is 1,500 participants, above the 1,330-participant average among 20 other Coronavirus trials with a reported enrollment target (13% higher). The trial reports 6 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT07221097, a study of Coronavirus and COVID, is actively recruiting participants, sponsored by BioFire Defense.

RECRUITING
Registry status
1,500 participants
Enrollment target
6
Study locations

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.

Primary Outcome

Positive Percent Agreement and Negative Percent Agreement for Panel Targets

Conditions Studied

Coronavirus COVID Respiratory Infection

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
BioFire Defense

2 total trials

What NCT07221097 shows while recruiting

NCT07221097 is an observational study that tracks outcomes without assigning an intervention. Its 1,500 participants enrollment target places it among the larger protocols in the corpus, above the 1,330-participant average among 20 other Coronavirus trials with a reported enrollment target (13% higher).

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.

NCT07221097 lists 6 locations in 6 states (California, District of Columbia, Florida).

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.

What interventions are being tested in trial NCT07221097?

The interventions under investigation include: Investigational IVD for coronaviruses (DEVICE).

Who is sponsoring clinical trial NCT07221097?

This trial is sponsored by BioFire Defense, which has 2 total clinical trials registered on ClinicalTrials.gov.

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.

Learn More About Clinical Trials

Similar trials for Coronavirus

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 NCT07221097's enrollment target sits among peer trials

1,500 3rd of 20 higher than 18 of 20 other Coronavirus trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Coronavirus 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.

Source ClinicalTrials.gov registry export · 2026-08-08

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More recruiting context for NCT07221097

Source: ClinicalTrials.gov NCT07221097, the US trial registry maintained by the National Library of Medicine. NCT07221097 (large enrollment · multi site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.