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Gazelle COVID-19 Test Clinical Accuracy Protocol
Gazelle COVID-19 is a fluorescent lateral flow immunoassay and accompanying Reader intended for the qualitative detection of nucleocapsid antigen from SARS-CoV-2 in nasal swab specimens from individuals who are suspected of COVID-19 by their healthcare provider within 5 days of symptom onset. The study will be conducted To obtain data to measure the positive percent agreement and negative percent agreement of the Gazelle COVID-19 Test compared to Reverse Transcriptase Polymerase Chain Reaction (RT-PCR).The study will assess Gazelle COVID-19 Test performance using dual mid-turbinate nasal swab samples. This study will primarily assess Gazelle COVID-19 Test performance on symptomatic subjects (within five days of onset of symptoms) at point of care (POC). A subset of asymptomatic subjects will be enrolled after the symptomatic subject enrollment is complete.
Conditions:
🦠 Covid19
🗓️ Study Start (Actual) 20 August 2021
🗓️ Primary Completion (Estimated) 15 December 2022
✅ Study Completion (Estimated) 30 December 2022
👥 Enrollment (Estimated) 1500
🔬 Study Type OBSERVATIONAL
📊 Phase N/A
Locations:
📍 Bellingham, Washington, United States

📋 Eligibility Criteria

Description

  • Symptomatic study:

    • Inclusion Criteria:

    • The presence of clinical signs and symptoms consistent with COVID-19. Signs and symptoms include:
    • * Fever
    • * Coughing
    • * Shortness of breath
    • * Recent loss of sense of smell or taste
    • * Chills
    • * Repeated shaking with chills
    • * Muscle pain
    • * Headache
    • * Sore throat
    • * Vomiting or diarrhea
    • * Within 1-5 days of symptom onset
    • * Informed consent for all the samples will be obtained from the subject or obtained from the parent/guardian in case the patient is a minor
    • * All ages
    • * All genders
    • * Pregnant women

    Exclusion Criteria:

    • * Severe disease requiring immediate medical intervention
    • * Inability to tolerate sampling procedure (nasal swab)
    • * Failure to provide informed consent
    • * Nasal deformities preventing sampling by swab
    • * Ongoing nosebleeds or use of a nasal spray within the last 4 hours.
    • * Asymptomatic patients
    • Asymptomatic study:

    Inclusion Criteria:

    • * Present to the facility for a COVID-19 test without symptoms
    • * Informed consent for all specimens will be obtained from the patient or obtained from the parent/guardian in case the patient is a minor

    Exclusion Criteria:

    • Exclusion criteria include one or more of the following:
    • * Severe disease requiring immediate medical intervention
    • * Inability to tolerate sampling procedure
    • * Is below 2 years old
    • * Failure to provide informed consent
    • * Nasal deformities preventing sampling by swab
    • * Ongoing nosebleeds or use of a nasal spray within the last 4 hours.
    • * Presence of typical symptoms of COVID-19 (fever, sore throat, fatigue, etc.)
Ages Eligible for Study: N/A to N/A (CHILD, ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 30 July 2021
  • First Submitted that Met QC Criteria 30 July 2021
  • First Posted 3 August 2021

Study Record Updates

  • Last Update Submitted that Met QC Criteria 8 August 2022
  • Last Update Posted 10 August 2022
  • Last Verified August 2022
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