MedTrace Logo

Rapid, Onsite COVID-19 Detection

NCT04460690 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 93

Last updated 2022-01-20

Study results available
· View outcomes & findings →

Summary

The purpose of this research study is to evaluate and improve a rapid COVID-19 test. The test is designed to identify people who are most contagious and likely to spread the virus to others. This test will be performed at various locations in the Madison area using a mobile laboratory or standard lab space for processing. Saliva samples can be collected and processed at these locations or participants can self-collect at home and drop their samples off at designated locations for same day processing. Results of potential findings of clinical significance will be communicated to the participants by a physician with appropriate expertise on the study team. Individuals with a potential finding of clinical significance will be encouraged to self-isolate and obtain a diagnostic test at their earliest convenience. No results will be given if the test is negative. If the participant consents, advanced molecular testing such as PCR or viral sequencing can be done and results can be shared via online databases, presentations and publications along with the date, site and county of collection to help facilitate tracking the spread of the virus.

Conditions

Interventions

DEVICE

Rapid Onsite COVID-19 Detection

saliva assay test for high concentrations of SARS-CoV-2

Sponsors & Collaborators

  • National Institutes of Health (NIH)

    collaborator NIH

  • AIDS Vaccine Research Lab

    collaborator UNKNOWN

  • University of Wisconsin, Madison

    lead OTHER

Principal Investigators

  • David O'Connor, PhD · University of Wisconsin, Madison

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
5 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-13
Primary Completion
2021-03-31
Completion
2021-03-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04460690 on ClinicalTrials.gov