Clinical Trials Logo
  1. Home
  2. SARS-CoV2 Infection
  3. NCT05124496
  4. Details
NCT05124496 Clinical Trial

Validation of HyperDetector for SARS-CoV-2

SARS-COV2 Infection Clinical Trial

Official title:
Validation of the HyperDetector Digital Solution Screening Assay for Rapid Screening for Potential SARS-CoV-2 (COVID-19) Infection

Clinical Trial Details — Status: Suspended

Administrative data
NCT number NCT05124496
Other study ID # 20204146
Secondary ID
Status Suspended
Phase
First received
Last updated
Start date December 11, 2020
Est. completion date December 30, 2021

Study information
Verified date November 2021
Source HyperSpectral APD
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Suspended
Enrollment 10000
Est. completion date December 30, 2021
Est. primary completion date December 30, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 5 Years and older
Eligibility Inclusion Criteria: - Subjects at COVID-19 testing site for Rt-PCR test. Exclusion Criteria: - Minors under the age of 5

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
United States HyperSpectral APD, LLC Alexandria Virginia

Sponsors (1)
Lead Sponsor Collaborator
HyperSpectral APD

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Sensitivity To determine the sensitivity of the screening assay By 12/30/2022
Primary Specificity To determine the specificity of the screening assay By 12/30/2022
See also
  Status Clinical Trial Phase
Completed NCT04979858 - Reducing Spread of COVID-19 in a University Community Setting: Role of a Low-Cost Reusable Form-Fitting Fabric Mask N/A
Recruiting NCT05311410 - Viral Kinetics of SARS-CoV-2 in Patients With COVID-19 in the Intensive Care Unit Undergoing Dental Procedures N/A
Active, not recruiting NCT05073718 - SARS-CoV-2 and Acetylsalicylic Acid (SARA) Phase 3
Completed NCT05060510 - The School SPIT Study - COVID-19 Testing in Secondary Schools N/A
Completed NCT05055492 - The School SPIT Study - Elementary Schools in High COVID-19 Incidence Regions N/A
Completed NCT05055505 - The School SPIT Study - Elementary Schools in Low COVID-19 Incidence Regions N/A
Completed NCT05054218 - COVID-19 Immunogenicity of a Third Dose of mRNA-1273 Vaccine Among Cancer Patients
Completed NCT05449392 - Topical Antibacterial Agents for Prevention of COVID-19 Phase 1
Completed NCT05076253 - Efficacy of Ivermectin in COVID-19 Phase 1/Phase 2
Recruiting NCT05172024 - Understanding the Long-term Impact of COVID-19 in Adults (RECOVER)
Terminated NCT05593770 - International Sites: Novel Experimental COVID-19 Therapies Affecting Host Response Phase 2/Phase 3
Completed NCT05030974 - RECOVAC Repeated Vaccination Study Phase 4
Withdrawn NCT05067946 - Evaluation of Efficacy, Safety and Immunogenicity of GX-19N in Healthy Individuals Who Have Received COVID-19 Vaccines Phase 2/Phase 3
Not yet recruiting NCT05013034 - Exploratory Regimen of Basiliximab for Treatment of Pulmonary Cytokine Storm in SARS-CoV-2 Hospitalized Adult Patients Phase 2
Withdrawn NCT05393999 - SABRE: A Single-arm Prospective Study Measuring Safety and Tolerability of SARS-CoV-2 Neutralising Antibodies in High-risk Populations Phase 2
Recruiting NCT05047783 - Masitinib in Patients With Symptomatic Mild to Moderate COVID-19 Phase 2
Not yet recruiting NCT05116657 - Obstructive Sleep Apnoea Post Covid 19: Role of the Upper Airway Microbiome
Recruiting NCT04590222 - Impact of a Monoamine Oxidase Inhibitor on the Phenotype of Blood Mononucleated Cells in Patients With COVID-19
Completed NCT04953039 - Use of Saliva for COVID-19 Diagnosis
Recruiting NCT04999098 - Echinaforce COVID-19 Shedding Study Phase 4