NCT05213897

Brief Summary

The purpose of this study is to evaluate the performance of Freedom For All Diagnostics, Inc.'s colloidal gold immune technology SARS-CoV-2 Antigen investigational assay when compared to a high-sensitivity Emergency Use Authorization (EUA) SARS-CoV-2 RT-PCR assay. The study will evaluate the accuracy in the intended use environment of the SARS-CoV-2 antigen assay when testing is conducted in a CLIA-waived setting (e.g., a physician's office or clinic) by non-laboratory personnel serving in a healthcare facility or setting.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
232

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

January 25, 2022

Completed
2 days until next milestone

Study Start

First participant enrolled

January 27, 2022

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 28, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2022

Completed
Last Updated

June 2, 2022

Status Verified

June 1, 2022

Enrollment Period

4 months

First QC Date

January 25, 2022

Last Update Submit

June 1, 2022

Conditions

Covid-19

Outcome Measures

Primary Outcomes (1)

  • Assay Sensitivity - 80% (versus the EUA SARS-CoV-2 RT-PCR assay)

    SARS-CoV-2 Antigen investigational assay shall have an observed sensitivity of at least 80% when the EUA SARS-CoV-2 RT-PCR assay for nasopharyngeal swabs is used as a reference method.

    48 hours

Study Arms (2)

30 subjects testing positive for Covid-19

30 subjects testing positive for Covid-19 using the proprietary SARS-CoV-2 Antigen Assay

Device: SARS-CoV-2 Antigen Assay

30 subjects testing negative for Covid-19

30 subjects testing negative for Covid-19 using the proprietary SARS-CoV-2 Antigen Assay

Device: SARS-CoV-2 Antigen Assay

Interventions

SARS-CoV-2 Antigen AssayDEVICE

To demonstrate that non-laboratory personnel can accurately perform the SARS-CoV-2 Antigen assay in the intended use environment using nasopharyngeal samples by demonstrating that the assay can achieve a ≥ 80% sensitivity and specificity when it is compared to the results of a high sensitivity EUA SARSCoV-2 RT-PCR assay using nasopharyngeal samples.

30 subjects testing negative for Covid-1930 subjects testing positive for Covid-19

Eligibility Criteria

Age2 Years - 94 Years
Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients experiencing symptoms and presenting for testing of Covid-19.

You may qualify if:

  • Subject suspected of having COVID-19 infection and within 7 days of symptom onset. This will include at least one of the following:
  • Fever or chills
  • Cough
  • Shortness of breath or difficulty breathing
  • Fatigue
  • Muscle or body aches
  • Headache
  • New loss of taste or smell
  • Sore throat
  • Congestion or runny nose
  • In addition to the above primary symptoms, the Subject might also report nausea, vomiting and/or diarrhea, but these symptoms alone are not sufficient to include the Subject in the study.
  • Subject is willing to provide consent/assent.
  • Subject is willing to have two (2) nasopharyngeal swabs collected for the study and in the event of inconclusive results, be willing to return to the site to have two (2) more nasopharyngeal swabs

You may not qualify if:

  • To be enrolled in the study, each Subject must not meet:
  • Subject unable or unwilling to provide informed consent/assent.
  • Subject tested positive for SARS-CoV-2 within the past 3 months.
  • Subject has already participated in this study.
  • Subject is a vulnerable population and deemed inappropriate for study by site Principal Investigator and/or IRB.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centennial Medical

Elkridge, Maryland, 21075, 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

  • Steven Geller, MD

    Centennial Medical Group

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 25, 2022

First Posted

January 28, 2022

Study Start

January 27, 2022

Primary Completion

June 1, 2022

Study Completion

June 1, 2022

Last Updated

June 2, 2022

Record last verified: 2022-06

Locations

US(1)