A Study of the GRIP Influenza and SARS-CoV-2 POC Assays

• Sponsor: Mayo Clinic (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05674370
• Collaborator: Department of Health and Human Services (U.S. Fed)
• Enrollment: 200
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 4.9
• Patients Per Site Per Month: 40.6

Study Details

Study Description

Brief Summary

The purpose of this research is to determine if the use of a new device can accurately detect a virus infection.

Condition or Disease	Intervention/Treatment	Phase
COVID-19; Influenza	Device: GRIP Electronic Diagnostic Chip; Diagnostic Test: Laboratory-based nucleic acid amplification tests (NAATs)	N/A

Detailed Description

GRIP has developed a novel, graphene-based detection system for potential use in point-of-care settings. This study will compare the performance of the GRIP device to routine PCR testing for detection of COVID-19 and influenza viruses. When patients present for routine testing for COVID-19 and influenza, they will also have a separate nasal swab collected that will be tested by the GRIP point-of-care device.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 200 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Clinical Evaluation of the GRIP Influenza and SARS-CoV-2 Point-of-care Assays Using Fresh Patient Nasal Swab Samples
• Anticipated Study Start Date: Feb 1, 2023
• Anticipated Primary Completion Date: Apr 1, 2023
• Anticipated Study Completion Date: Jul 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Novel, graphene-based, point-of-care device Subjects will receive one additional nasal swab at the same time as clinical collection.	Device: GRIP Electronic Diagnostic Chip; Graphene-based point-of-care device for detection of respiratory viruses (e.g., COVID-19 and influenza) from a nasal swab; Diagnostic Test: Laboratory-based nucleic acid amplification tests (NAATs); Polymerase Chain Reaction (PCR) analysis for detection of viruses (e.g., Roche cobas SARS-CoV-2 or influenza A/B) from nasal swab

Outcome Measures

Primary Outcome Measures

1. Positive Percent Agreement [Baseline]

   Percent of nasal swabs to report positive results for respiratory virus for both the GRIP device and NAAT routine clinical testing

2. Negative Percent Agreement [Baseline]

   Percent of nasal swabs to report negative results for respiratory virus for both the GRIP device and NAAT routine clinical testing

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patients being tested for COVID 19 or Influenza

Exclusion Criteria:

• Patients < 18 years of age

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mayo Clinic Minnesota	Rochester	Minnesota	United States	55905

Sponsors and Collaborators

• Mayo Clinic
• Department of Health and Human Services

Investigators

• Principal Investigator: Matthew Binnicker, PhD, Mayo Clinic

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Mayo Clinic Clinical Trials

Publications

None provided.

• Responsible Party: Matthew J. Binnicker, Principal Investigator, Mayo Clinic
• ClinicalTrials.gov Identifier: NCT05674370
• Other Study ID Numbers: 22-011258; 75A50122C00039
• First Posted: Jan 6, 2023
• Last Update Posted: Jan 6, 2023
• Last Verified: Dec 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Additional relevant MeSH terms: Influenza, Human

Study Results

No Results Posted as of Jan 6, 2023