NCT04904510

Brief Summary

The INDICAID™ Rapid Antigen Test was used in real-world outbreak testing. The antigen test was used together with PCR testing. This study was designed to evaluate whether the addition of a rapid antigen test decreased time to results in a real-world setting.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
297

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2020

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

Study Start

First participant enrolled

November 20, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 9, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 9, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 19, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 27, 2021

Completed
1.7 years until next milestone

Results Posted

Study results publicly available

February 15, 2023

Completed
Last Updated

February 15, 2023

Status Verified

May 1, 2022

Enrollment Period

4 months

First QC Date

May 19, 2021

Results QC Date

February 2, 2022

Last Update Submit

May 18, 2022

Conditions

Covid19

Outcome Measures

Primary Outcomes (1)

  • Test Concordance

    The concordance with the INDICAID COVID-19 Rapid Antigen Test with an EUA PCR test

    Day 1

Study Arms (1)

Sample Collection

People routinely testing for COVID-19 would have an extra sample collected to assess the diagnostic device.

Diagnostic Test: INDICAID™ COVID-19 Rapid Antigen Test

Interventions

INDICAID™ COVID-19 Rapid Antigen TestDIAGNOSTIC_TEST

The diagnostic assay will be compared to a EUA SARS-CoV-2 assay

Sample Collection

Eligibility Criteria

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

People testing for COVID at multiple sites in California

You may qualify if:

  • at least 5 years of age and report onset
  • at least two of the following COVID-19 symptoms within 5 days or less: fever or chills, fatigue, sore throat, congestion or runny nose, cough, headache, diarrhea, shortness of breath or difficulty breathing, muscle or body aches, new loss of taste or smell, nausea, or vomiting.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CityHealth Urgent Care Oakland

Oakland, California, 94612, United States

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

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

Results Point of Contact

Title
Dr. Noah Kojima
Organization
UCLA
nkojima@ucla.edu
(310) 319-4377

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 19, 2021

First Posted

May 27, 2021

Study Start

November 20, 2020

Primary Completion

March 9, 2021

Study Completion

March 9, 2021

Last Updated

February 15, 2023

Results First Posted

February 15, 2023

Record last verified: 2022-05

Locations

US(1)