NCT05610449

Brief Summary

This study will measure the sensitivity and specificity of the Testing Done Simple severe acute respiratory syndrome (SARS) CoV-2 antigen test in subjects with suspected Covid-19 that present throughout several urgent care clinics. The antigen test performance will be compared to a real-time polymerase chain reaction (RT-PCR) test.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
171

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2022

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

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

Study Start

First participant enrolled

November 4, 2022

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

November 7, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 9, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 17, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

March 29, 2023

Completed
Last Updated

May 15, 2023

Status Verified

May 1, 2023

Enrollment Period

4 months

First QC Date

November 7, 2022

Last Update Submit

May 12, 2023

Conditions

COVID-19

Keywords

Antigen testTestDiagnosis

Outcome Measures

Primary Outcomes (2)

  • Sensitivity

    Sensitivity (True Positive Rate) of Testing Done Simple Antigen Test compared to RT-PCR

    15 minutes

  • Specificity

    Specificity (True Negative Rate) of Testing Done Simple Antigen Test compared to RT-PCR

    15 minutes

Secondary Outcomes (1)

  • Sensitivity in Relation to the Time Since Symptom Onset in Symptomatic subjects

    15 minutes

Study Arms (2)

Testing Done Simple Antigen test in Symptomatic Subjects (Nasal swab)

Diagnostic Test: Testing Done Simple SARS CoV-2 Antigen Test

Testing Done Simple Antigen test in Asymptomatic Subjects (Nasal swab)

Diagnostic Test: Testing Done Simple SARS CoV-2 Antigen Test

Interventions

Testing Done Simple SARS CoV-2 Antigen TestDIAGNOSTIC_TEST

Collections of specimens from subjects presenting with Covid-19 like symptoms or known/suspected exposure to SARS CoV-2 via nasal swabs administered by trained medical personnel.

Testing Done Simple Antigen test in Asymptomatic Subjects (Nasal swab)Testing Done Simple Antigen test in Symptomatic Subjects (Nasal swab)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The cohorts consist of a symptomatic group of patients with Covid related symptoms and an asymptomatic group of patients that may have been exposed to Covid through another person

You may qualify if:

  • Subject was given a SARS CoV 2 PCR test for any of the following 4 reasons:
  • Subject has Covid like symptoms that started within past (7) days
  • Subject has been exposed to another individual with a known Covid diagnosis or probable Covid diagnosis
  • Subject needs Covid test done for travel, school, work, etc
  • Subject works in a high risk environment
  • Subject can provide a nasal swab sample
  • Subject is at least 18 years of age
  • Subject was given a SARS CoV 2 PCR test on same day participating this study
  • Subject provides informed consent

You may not qualify if:

  • Subject is less than 18 years of age
  • Subject does not provide consent
  • Subject's Covid 19 related symptom(s) started greater than 7 days from visit
  • Asymptomatic subjects whom have had symptom(s) within past (14) days
  • Signs of local infection in the area of the face
  • Subject was not given a SARS CoV 2 PCR test on same day as study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Nao Medical Urgent Care-Astoria

Queens, New York, 11105, United States

Location

Nao Medical Urgent Care-Jackson Heights

Queens, New York, 11372, United States

Location

MeSH Terms

Conditions

COVID-19Disease

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

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

Study Record Dates

First Submitted

November 7, 2022

First Posted

November 9, 2022

Study Start

November 4, 2022

Primary Completion

February 17, 2023

Study Completion

March 29, 2023

Last Updated

May 15, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations

US(2)