NCT04847479: CloseST

COVID-19 Close Contact Self-Testing Study

Completed NA Results posted Last updated 3 February 2025

What this trial tests

NA trial testing COVID-19 self-test in Covid19 in 3 participants. Completed in 29 November 2023.

Timeline

6 May 2021

Primary endpoint
29 November 2023

29 November 2023

Quick facts

Lead sponsor	University of Pennsylvania
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	health services research
Enrollment	3
Start date	6 May 2021
Primary completion	29 November 2023
Estimated completion	29 November 2023
Sites	1 location across United States

Drugs / interventions tested

• COVID-19 self-test
• COVID-19 test referral

Conditions studied

• Covid19 — all drugs for Covid19 →

Sponsor

University of Pennsylvania

Who can join

18 and older, any sex, with Covid19. 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.

Number of Positive Contacts Primary · 8 weeks

Number of close contacts who test positive for COVID-19

Group	Value	95% CI
Self-Test Kit Distribution	0
Test Referral Distribution	0

Number of Positive Contacts (End of Study) Secondary · Through study completion, up to one year

Number of close contacts who test positive for COVID-19 by the end of the study

Group	Value	95% CI
Self-Test Kit Distribution	0
Test Referral Distribution	0

Number of Contacts Tested Secondary · 8 weeks

Number of close contacts who completed a test

Group	Value	95% CI
Self-Test Kit Distribution	2

Number of Contacts Tested (End of Study) Secondary · Through study completion, up to one year

Number of close contacts who completed a test by the end of the study

Group	Value	95% CI
Self-Test Kit Distribution	0
Test Referral Distribution	0

Number of Household Contacts Tested Secondary · 8 weeks

Number of household contacts who completed a test

Group	Value	95% CI
Self-Test Kit Distribution	0
Test Referral Distribution	0

Number of Household Contacts Tested (End of Study) Secondary · Through study completion, up to one year

Number of household contacts who completed a test by the end of the study

Group	Value	95% CI
Self-Test Kit Distribution	0
Test Referral Distribution	0

Sponsor's own description

Widespread testing and contact tracing are critical to controlling the COVID-19 epidemic. Distribution of COVID-19 self-test kits can augment public health contact tracing efforts, as individuals with COVID-19 can distribute self-testing to close contacts. This approach can increase case detection by facilitating testing among exposed individuals, and potentially ameliorate stigma, fear, and medical mistrust associated with COVID-19 among vulnerable populations.

The central hypothesis of this study is that distribution of SARS-CoV-2 self-tests to close contacts of among individuals with COVID-19 infection can increase case detection compared with a standard contact referral strategy.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Workplace interventions to reduce the risk of SARS-CoV-2 infection outside of healthcare settings.
   Constantin AM, Noertjojo K, Sommer I, Pizarro AB, et al · · 2024 · cited 2× · PMID 38597249 · DOI 10.1002/14651858.cd015112.pub3