Clinical trial NCT04987918: Gazelle COVID-19 Test Clinical Accuracy Protocol
Official title: Gazelle COVID-19 Test Clinical Accuracy Protocol
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Covid19
Lead sponsor: Hemex Health
Sponsor class: INDUSTRY
First posted: 2021-08-03
Enrollment: 1500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Consecutive subjects of all ages who visit the facility for covid 19 testing (symptomatic and asymptomatic).

Brief summary: 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.


Eligibility criteria: 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.)

Primary outcomes:
measure: Positive percent agreement and negative percent agreement of the Gazelle COVID-19 Test compared to Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) will be measured
timeFrame: 3 months
Secondary outcomes:
measure: Sensitivity and specificity on at least 30, maximum 65, SARS-CoV-2 positive patient samples will be assessed
timeFrame: 6 months
Other outcomes:
Locations:
city: Bellingham
country: United States
facility: Northwest Pathology drive thru site, Bellingham International Airport
state: Washington
Study officials:
affiliation: Northwest Pathology
name: Ryan Robert Fortna, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: