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

Part of paid clinical trials in Los Angeles, California.

Sponsor
BioFire Defense LLC
Study ID
NCT07221097
Status
Recruiting
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Conditions

  • COVID
  • Coronavirus
  • Respiratory Infection

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • Investigational IVD for coronaviruses — DEVICE
    Device testing on prospectively collected specimens leftover from standard of care for IVD validation only; results will not influence patient care/management.

Study Details

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.

Key Dates

Start date
Sep 29, 2025
Status verified
Oct 2025
Primary completion
Jun 30, 2026
Completion
Aug 31, 2026

Study Design

Enrollment
1,500 participants (estimated)

Arms

  • Arm: Suspected respiratory infection
    NPS specimens leftover from SOC testing for a suspected respiratory infection as determined by a health care provider

Primary Outcome Measure

Device Performance [ Time Frame: Through study completion; September 2025-August 2026 ]

Central Contacts

Locations (6)

FacilityCityStateZIPSite coordinators
Children's Hospital Los AngelesLos AngelesCalifornia90027
Jenn Dien Bard, PhD D(ABMM) F(CCM)
[email protected]
(323) 361-5443
George Washington UniversityWashington D.C.District of Columbia20037
Aileen Chang, MD MSPH FACP
[email protected]
(202) 677-6562
Tampa General HospitalTampaFlorida33606
Suzane Silbert, PhD
[email protected]
(813) 844-4261
Emory University HospitalAtlantaGeorgia30032
Colleen Kraft, MD MSc
[email protected]
(404) 712-8889
Wake Forest University Health SciencesWinston-SalemNorth Carolina27157-1042
John Williamson, PharmD
[email protected]
336-716-2700
University of Texas Medical BranchGalvestonTexas77550
Corri Levine, PhD MS MPH
[email protected]
(409) 747-1928

Find similar trials in Los Angeles, CA

By condition
COVID-19 / long COVID
By specialty
Infectious disease
By research site
Children's Hospital Los Angeles· Los Angeles, CAGeorge Washington University· Washington D.C., DCTampa General Hospital· Tampa, FLEmory University Hospital· Atlanta, GAWake Forest University Health Sciences· Winston-Salem, NCUniversity of Texas Medical Branch· Galveston, TX

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