An observational study in COVID-19, sponsored by Exact Sciences Corporation. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-12-13.
Sponsored by Exact Sciences Corporation · Observational
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.
This study is a prospective observational human factors usability study designed to evaluate the Instructions For Use (IFU) in the SARS-CoV-2 Specimen Collection Materials based on the successful completion of self-collection of a nasal swab sample, which includes a valid SARS-CoV-2 test result.
7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.
This study's enrollment of 30 is below the median of 261 across 3,136 observational studies indexed under COVID-19.
Browse COVID-19 studies →Exact Sciences Corporation is the lead sponsor of 31 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
Determine usability of study materials and kit
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)
Time frame: Subjects are assessed at enrollment
| Milestone | Volunteers |
|---|---|
| Started | 30 |
| Completed | 30 |
| Not completed | 0 |
The percent of samples from the fully enrolled cohort to return a valid SARS-CoV-2 test result (positive, not detected, or inconclusive)
| Participants | Volunteers |
|---|---|
| Valid SARS-CoV-2 Test | 30 |
Collected over Adverse event collection began at enrollment and ended after completion of the sample collection, up to one hour.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Volunteers | 0/30 (0%) | 0/30 (0%) | 0/30 (0%) |
| Age, Categorical(Participants) | Volunteers |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 30 |
| >=65 years | 0 |
| Sex: Female, Male(Participants) | Volunteers |
|---|---|
| Female | 18 |
| Male | 12 |
| Race (NIH/OMB)(Participants) | Volunteers |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 2 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 2 |
| White | 26 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | Volunteers |
|---|---|
| United States | 30 |
| Level of Education(Participants) | Volunteers |
|---|---|
| College degree, or higher | 23 |
| Other level of education | 7 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — Individual participant data that underlie the results reported in publications of the study will be shared after deidentification. This may include text, tables, figures, and appendices. The study protocol, informed consent form (when applicable), and statistical analysis plan (when applicable) will also be shared.
Supporting information: Study protocol, Sap, Icf
This study is completed, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.
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Exact Sciences Corporation