Covid19NCT04987918
Gazelle COVID-19 Test Clinical Accuracy Protocol
An observational study of Covid19, run by Hemex Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Covid19
- What is being tested?
- Applied Biosystems TaqPath COVID- 19 Combo Kit
- How many people
- 1,500 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Aug 2021to 30 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Consecutive subjects of all ages who visit the facility for covid 19 testing (symptomatic and asymptomatic).
Who may be able to join
- 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
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- 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
- 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
Who cannot join
- 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
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- Asymptomatic study:
- 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.)
Trial locations and contacts
1 site in 1 country.
David Bell, MD contact
United States1 site, 1 recruiting
- Recruiting
Northwest Pathology drive thru site, Bellingham International Airport
Bellingham, Washington, 98226
Bri Spencer, Bri.Spencer@nwlaboratory.com
About this study
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
- Being tested
- Applied Biosystems TaqPath COVID- 19 Combo Kit
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Applied Biosystems TaqPath COVID- 19 Combo KitDiagnostic test
Reverse Transcriptase Polymerase Chain Reaction (RT-PCR)
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 months
Secondary outcomes (1)
Sensitivity and specificity on at least 30, maximum 65, SARS-CoV-2 positive patient samples will be assessed
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2021
- Study start20 Aug 2021
- Primary completion15 Dec 2022 (estimated)
- Study completion30 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hemex Health
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ryan Robert Fortna, MD, PhD, Principal investigator, Northwest Pathology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04987918
- Sponsor's protocol ID
- GZL-FC10-PTL-0001
- Status last verified
- Aug 2022
- First submitted
- 30 Jul 2021
- Last updated
- 10 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gazelle COVID-19 Test Clinical Accuracy Protocol
- ClinicalTrials.gov ID
- NCT04987918
- Acronym / sponsor ID
- GZL-FC10-PTL-0001
- Conditions
- Covid19
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Hemex HealthIndustry (pharma, biotech, devices)
- Study start
- 20 Aug 2021 (actual)
- Primary completion
- 15 Dec 2022 (estimated)
- Study completion
- 30 Dec 2022 (estimated)
- First posted
- 3 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Consecutive subjects of all ages who visit the facility for covid 19 testing (symptomatic and asymptomatic).
Key inclusion criteria (18 listed)
- 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
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Applied Biosystems TaqPath COVID- 19 Combo KitReverse Transcriptase Polymerase Chain Reaction (RT-PCR) | Diagnostic test | – |
Primary outcome
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
Time frame: 3 months
1 secondary outcome
Sensitivity and specificity on at least 30, maximum 65, SARS-CoV-2 positive patient samples will be assessed
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Bell, MD contact
Ryan Robert Fortna, MD, PhD principal investigator
Northwest Pathology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19, run by Hemex Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact PRIYA THOTA, MD (2162339405, p.thota@hemexhealth.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2022.