NCT04977050

The Role of Frequent Point-of-care Molecular Workplace Surveillance for Miners

Completed NA Results posted Last updated 3 April 2024

What this trial tests

NA trial testing Quidel quickvue antigen test for COVID-19 in Covid19 in 230 participants. Completed in 31 October 2022.

Timeline

22 February 2021

Primary endpoint
31 October 2022

31 October 2022

Quick facts

Lead sponsor	University of New Mexico
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	230
Start date	22 February 2021
Primary completion	31 October 2022
Estimated completion	31 October 2022
Sites	1 location across United States

Drugs / interventions tested

• Quidel quickvue antigen test for COVID-19

Conditions studied

• Covid19 — all drugs for Covid19 →

Sponsor

University of New Mexico

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 Participants Screened (Molecular) Primary · 12 months

Rapid antigen test for COVID-19

Group	Value	95% CI
Intervention Site	169
Controled Site	61

Sponsor's own description

The long-term goal of the study is to mitigate the spread of the pandemic in miners, a population of high-risk, rural essential workers who are susceptible and vulnerable to COVID-19, partly based on exposure to particulate air pollution, and who are predominantly racial/ethnic minorities in New Mexico (NM) (3, 11). The study objective is to provide proof-of-principle for frequent point-of-care molecular testing as a workplace surveillance tool to monitor and prevent the spread of SARS-CoV-2 infection in this unique population. The central hypothesis is that frequent workplace molecular surveillance is an effective method to reduce SARS-CoV-2 infection and discover novel host risk factors for the virus. The site of molecular surveillance (intervention site) will be a surface coal mine in McKinley County, NM, located just outside the Eastern Agency of the Navajo Nation, comprised of 66% minority miners. This site offers a unique opportunity for a community-based study of SARS-CoV-2 infection in this population. Miners at the intervention site will provide nasal swabs before beginning their work shift on alternate days that will be analyzed with a 'screening' molecular test (12). This test is ideal because it is low cost, simple, portable, point-of-care, rapid, and can be performed by minimally trained professionals in low-infrastructure settings. The control site is a similar coal mine in Campbell County, Wyoming (WY). Both mines, operated by the same company, have similar engineering, administrative, and personal protective measures in place. The rationale for this study is to establish the suitability of longitudinal molecular surveillance to prevent and control SARS-CoV-2 infection in this unique population by completing the following specific aims.

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