Trial Outcomes & Findings for The Role of Frequent Point-of-care Molecular Workplace Surveillance for Miners (NCT NCT04977050)
NCT ID: NCT04977050
Last Updated: 2024-04-03
Results Overview
Rapid antigen test for COVID-19
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
230 participants
Primary outcome timeframe
12 months
Results posted on
2024-04-03
Participant Flow
Participant milestones
| Measure |
Intervention Site
All miners in the New Mexico intervention mine site who will be administered nasal swabs for antigen testing every other work shift, and serological testing 3 months.
Quidel quickvue antigen test for COVID-19: rapid antigen test on nasal swab specimen for COVID-19
|
Controled Site
All miners in the Wyoming Control mine site who will be administered serological testing 3 months.
|
|---|---|---|
|
Overall Study
STARTED
|
169
|
61
|
|
Overall Study
COMPLETED
|
169
|
61
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
3 participants opted to not report or reported as intersex.
Baseline characteristics by cohort
| Measure |
Intervention Site
n=169 Participants
All miners in the New Mexico intervention mine site who will be administered nasal swabs for antigen testing every other work shift, and serological testing 3 months.
Quidel quickvue antigen test for COVID-19: rapid antigen test on nasal swab specimen for COVID-19
|
Controled Site
n=61 Participants
All miners in the Wyoming Control mine site who will be administered serological testing 3 months.
|
Total
n=230 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
13 Participants
n=169 Participants
|
0 Participants
n=61 Participants
|
13 Participants
n=230 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
154 Participants
n=169 Participants
|
60 Participants
n=61 Participants
|
214 Participants
n=230 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=169 Participants
|
1 Participants
n=61 Participants
|
3 Participants
n=230 Participants
|
|
Age, Continuous
|
44 years
STANDARD_DEVIATION 11.2 • n=169 Participants
|
45.2 years
STANDARD_DEVIATION 11.9 • n=61 Participants
|
44.6 years
STANDARD_DEVIATION 11.3 • n=230 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=168 Participants • 3 participants opted to not report or reported as intersex.
|
11 Participants
n=59 Participants • 3 participants opted to not report or reported as intersex.
|
25 Participants
n=227 Participants • 3 participants opted to not report or reported as intersex.
|
|
Sex: Female, Male
Male
|
154 Participants
n=168 Participants • 3 participants opted to not report or reported as intersex.
|
48 Participants
n=59 Participants • 3 participants opted to not report or reported as intersex.
|
202 Participants
n=227 Participants • 3 participants opted to not report or reported as intersex.
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
97 Participants
n=169 Participants
|
4 Participants
n=61 Participants
|
101 Participants
n=230 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
63 Participants
n=169 Participants
|
54 Participants
n=61 Participants
|
117 Participants
n=230 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
9 Participants
n=169 Participants
|
3 Participants
n=61 Participants
|
12 Participants
n=230 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
27 Participants
n=169 Participants
|
2 Participants
n=61 Participants
|
29 Participants
n=230 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=169 Participants
|
0 Participants
n=61 Participants
|
1 Participants
n=230 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=169 Participants
|
0 Participants
n=61 Participants
|
0 Participants
n=230 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=169 Participants
|
0 Participants
n=61 Participants
|
0 Participants
n=230 Participants
|
|
Race (NIH/OMB)
White
|
96 Participants
n=169 Participants
|
56 Participants
n=61 Participants
|
152 Participants
n=230 Participants
|
|
Race (NIH/OMB)
More than one race
|
31 Participants
n=169 Participants
|
3 Participants
n=61 Participants
|
34 Participants
n=230 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
14 Participants
n=169 Participants
|
0 Participants
n=61 Participants
|
14 Participants
n=230 Participants
|
|
Region of Enrollment
United States
|
169 Participants
n=169 Participants
|
61 Participants
n=61 Participants
|
230 Participants
n=230 Participants
|
PRIMARY outcome
Timeframe: 12 monthsRapid antigen test for COVID-19
Outcome measures
| Measure |
Intervention Site
n=169 Participants
All miners in the New Mexico intervention mine site who will be administered nasal swabs for antigen testing every other work shift, and serological testing 3 months.
Quidel quickvue antigen test for COVID-19: rapid antigen test on nasal swab specimen for COVID-19
|
Controled Site
n=61 Participants
All miners in the Wyoming Control mine site who will be administered serological testing 3 months.
|
|---|---|---|
|
Number of Participants Screened (Molecular)
|
169 Participants
|
61 Participants
|
Adverse Events
Intervention Site
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Controled Site
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place