NCT05124496

Brief Summary

To evaluate the HyperDetector as a method to rapidly screen SARS-CoV-2 To determine the sensitivity and specificity of the screening assay performed on oral swab and saliva specimens, compared to a validated RT-PCR COVID-19 method using nasal or nasopharyngeal swabs and to separately collected nasal swabs, oral swabs, oral rinse and saliva samples. To determine the best workflow for using such an assay to reflex suspicious/positive samples to a validated RT-PCR COVID-19 assay.

Trial Health

33
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Trial recruitment is currently suspended
Enrollment
10,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2020

Geographic Reach
1 country

1 active site

Status
suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 11, 2020

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

November 15, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 18, 2021

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2021

Completed
Last Updated

November 18, 2021

Status Verified

November 1, 2021

Enrollment Period

1.1 years

First QC Date

November 15, 2021

Last Update Submit

November 15, 2021

Conditions

SARS-COV2 Infection

Outcome Measures

Primary Outcomes (2)

  • Sensitivity

    To determine the sensitivity of the screening assay

    By 12/30/2022

  • Specificity

    To determine the specificity of the screening assay

    By 12/30/2022

Study Arms (1)

Comparison to Rt-PCR

Device: Screening Device

Interventions

Screening DeviceDEVICE

Screening device comparing Rt-PCR positive and negative results to HyperDetector results

Comparison to Rt-PCR

Eligibility Criteria

Age5 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Individuals obtaining Rt-PCR test

You may qualify if:

  • Subjects at COVID-19 testing site for Rt-PCR test.

You may not qualify if:

  • Minors under the age of 5

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

HyperSpectral APD, LLC

Alexandria, Virginia, 22314, United States

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Lauren Stack

    HyperSpectral APD, LLC

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 15, 2021

First Posted

November 18, 2021

Study Start

December 11, 2020

Primary Completion

December 30, 2021

Study Completion

December 30, 2021

Last Updated

November 18, 2021

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)