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Rapid Turnaround, Home-based Saliva Testing for COVID-19

NCT04568122 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1277

Last updated 2024-01-10

Study results available
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Summary

The aim of the study is to demonstrate the feasibility and validity of a saliva based home surveillance monitoring test for SARS-CoV-2 infection.

Participants will be asked to carry out as many tests as are included in the bag they are provided, on a daily basis until they are used up.

Conditions

  • Covid19

Interventions

DEVICE

Saliva test kit

Kit including tube with closed reagents using loop-mediated isothermal amplification (LAMP) assay to detect SARS-CoV-2 virus.

Sponsors & Collaborators

Principal Investigators

  • Manu Prakash, PhD · Stanford University

  • Manisha Desai, PhD · Stanford University

  • Euan A Ashley, MRCP, DPhil · Stanford University

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
2 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-11-20
Primary Completion
2022-12-10
Completion
2022-12-10
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

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 NCT04568122 on ClinicalTrials.gov