Gazelle COVID-19 Test Clinical Accuracy Protocol

Covid19 Clinical Trial

Official title:

Gazelle COVID-19 Test Clinical Accuracy Protocol

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04987918
• Other study ID #: GZL-FC10-PTL-0001
• Status: Recruiting
• Start date: August 20, 2021
• Est. completion date: December 30, 2022

Study information

• Verified date: August 2022
• Source: Hemex Health
• Contact: PRIYA THOTA, MD
• Phone: 2162339405
• Email: p.thota[@]hemexhealth.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1500
• Est. completion date: December 30, 2022
• Est. primary completion date: December 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.)

Related Conditions & MeSH terms

• COVID-19
• Covid19

Intervention

Diagnostic Test:
• Applied Biosystems TaqPath COVID- 19 Combo Kit
Reverse Transcriptase Polymerase Chain Reaction (RT-PCR)

Locations

Country	Name	City	State
United States	Northwest Pathology drive thru site, Bellingham International Airport	Bellingham	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Hemex Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		3 months
Secondary	Sensitivity and specificity on at least 30, maximum 65, SARS-CoV-2 positive patient samples will be assessed		6 months