UnknownNot Applicable

Gazelle COVID-19 Test Clinical Accuracy Protocol

United States1,500 participantsStarted 2021-08-20

Plain-language 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.

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 symp…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Trial details

NCT IDNCT04987918

SponsorHemex Health

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2022-12-15

Contact for this trial

PRIYA THOTA, MD

2162339405 p.thota@hemexhealth.com

View on ClinicalTrials.gov More Covid19 trials

Plain-language summary

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.