Home Usability Study of the SARS-CoV-2 (COVID-19) Test

NCT04395391 | Completed Results

• 1 other identifier: 2020-06
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective is to determine the usability of the SARS-CoV-2 Specimen Collection Materials for at-home collection and mailing of sample to the testing laboratory.

Conditions

COVID-19

Keywords

COVID-19; Sample Collection; Human Factors Study; Nasal Swab

Outcome Measures

Primary Outcomes (1)

• Valid SARS-CoV-2 Test

  The percent of samples from the fully enrolled cohort to return a valid SARS-CoV-2 test result (positive, not detected, or inconclusive)

  Subjects are assessed at enrollment

Interventions

SARS-CoV-2 DIAGNOSTIC_TEST

Determine usability of study materials and kit

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects of varying education levels, age, and health status. Subjects will be employees of Exact Sciences. Subjects are considered enrolled when they provide informed consent.

You may qualify if:

• Ability to provide informed consent

You may not qualify if:

• Prior medical or laboratory training
• Prior experience with COVID-19 specimen self-collection
• Prior SARS-CoV-2 testing

Sponsors & Collaborators

• Exact Sciences Corporation: lead

Study Sites (1)

Exact Sciences

Madison, Wisconsin, 53719, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Samples may be retained for purposes such as additional testing in this or alternative SARS-CoV-2 tests.

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Alexandra Massoud, Vice President of Clinical Affairs
• Organization: Exact Sciences

clinicaltrials@exactsciences.com

608-284-5700

Publication Agreements

• PI is Sponsor Employee: Yes
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

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

Study Record Dates

• First Submitted: May 19, 2020
• First Posted: May 20, 2020
• Study Start: May 18, 2020
• Primary Completion: May 21, 2020
• Study Completion: June 16, 2020
• Last Updated: December 13, 2023
• Results First Posted: December 13, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data will be available from 2 years and ending 4 years after publication. Data will be shared with researchers who provide a methodologically sound proposal to achieve the aims outlined in the approved proposal.
• Access Criteria: Proposals for access to data should be directed to clinicaltrials@exactsciences.com. To gain access, data requestors will need to provide a methodologically sound proposal and sign a data access agreement. Researchers are required to obtain necessary IRB/EC approvals or waivers as applicable to conduct research. Data will be available between 2 and 4 years after publication through the Sponsor.

Locations

US (1)