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NCT05216627: COVID SAFE 2

COVID-19 Screening Program

Completed Results posted Last updated 31 July 2024
What this trial tests

trial testing Self-administered saliva-based viral testing in COVID-19 in 61 participants. Completed in 1 July 2022.

Timeline
7 February 2022
Primary endpoint
1 July 2022
1 July 2022

Quick facts

Lead sponsorUniversity of Pennsylvania
StatusCompleted
Study typeOBSERVATIONAL
Enrollment61
Start date7 February 2022
Primary completion1 July 2022
Estimated completion1 July 2022
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

University of Pennsylvania

Who can join

18 and older, any sex, with COVID-19. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Use of a Voluntary COVID-19 Point of Care (POC) Screening Program Primary · fourteen weeks

How often they use the POC screening program

GroupValue95% CI
PSOM Staff, Trainees, or Faculty Who Participate in the Point of Care Testing238
Acceptability of Implementing a Voluntary COVID-19 Point of Care (POC) Screening Program Primary · fourteen weeks

Self-reported acceptability of implementing POC screening program using the Acceptability of Intervention Measure (i.e., "Point of care testing is acceptable to me"). Scale values: 1 (completely disagree) to 5 (completely agree).

GroupValue95% CI
PSOM Staff, Trainees, or Faculty Who Participate in the Point of Care Testing4.36± 0.72
Appropriateness of Implementing a Voluntary COVID-19 Point of Care (POC) Screening Program Primary · fourteen weeks

Self-reported appropriateness of implementing POC screening program using the Intervention Appropriateness Measure (i.e., "Point of care testing seems appropriate."). Scale values: 1 (completely disagree) to 5 (completely agree).

GroupValue95% CI
PSOM Staff, Trainees, or Faculty Who Participate in the Point of Care Testing4.40± 0.72
Feasibility of Implementing a Voluntary COVID-19 Point of Care (POC) Screening Program Primary · fourteen weeks

Self-reported feasibility of implementing POC screening program using the Feasibility of Intervention Measure (i.e., "Point of care testing seems feasible."). Scale values: 1 (completely disagree) to 5 (completely agree).

GroupValue95% CI
PSOM Staff, Trainees, or Faculty Who Participate in the Point of Care Testing4.29± 0.75
Self Report of Test Results Secondary · four weeks

Self-report of if participant received any positive test results from saliva-based viral test or Clinical Laboratory Improvement Amendments (CLIA) approved test

GroupValue95% CI
PSOM Staff, Trainees, or Faculty Who Participate in the Point of Care Testing1

Sponsor's own description

In view of the recent COVID surge and difficulties in obtaining testing, we aim to increase Point of Care (POC) testing, whereby University of Pennsylvania (Penn) faculty, staff, and trainees who are working in person at Perelman School of Medicine (PSOM) laboratories can self-test. The purpose of this study is to evaluate the implementation of this POC testing program. We will not be collecting any samples as part of this study. This will ensure that individuals can rapidly identify if they have COVID-19 while balancing use, acceptability, appropriateness, and feasibility. We will start with a pilot phase whereby we will evaluate the implementation of a POC version of COVID-19 screening program that will coordinate several existing systems at the University of Pennsylvania including voluntary, self-administered saliva-based viral testing. We will pilot this program to a small cohort of PSOM labs and then test implementation of the self-testing of the POC version of COVID-19 screening across all PSOM labs for those who wish to participate. All results will be self-reported and will not be used to validate any tests or support any future approval from the FDA. No data from this study will go into the participants' Electronic Medical Record (EMR).

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for COVID-19

Currently open trials in the same condition.

Other University of Pennsylvania trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05216627.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing