Trial Outcomes & Findings for Reducing Spread of COVID-19 in a University Community Setting: Role of a Low-Cost Reusable Form-Fitting Fabric Mask (NCT NCT04979858)
NCT ID: NCT04979858
Last Updated: 2023-04-03
Results Overview
Number of participants not infected by COVID-19 in a university setting.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
201 participants
Primary outcome timeframe
4 weeks
Results posted on
2023-04-03
Participant Flow
Participant milestones
| Measure |
Control Group
The subjects will choose their own mask and masking practices.
|
Treatment Group
The treatment group will receive and use the focal mask.
Focal Mask: The treatment group will receive and use the focal mask.
|
|---|---|---|
|
Pre-Treatment
STARTED
|
201
|
0
|
|
Pre-Treatment
COMPLETED
|
200
|
0
|
|
Pre-Treatment
NOT COMPLETED
|
1
|
0
|
|
Treatment
STARTED
|
100
|
100
|
|
Treatment
COMPLETED
|
100
|
100
|
|
Treatment
NOT COMPLETED
|
0
|
0
|
|
Post-Treatment
STARTED
|
100
|
100
|
|
Post-Treatment
COMPLETED
|
100
|
100
|
|
Post-Treatment
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Control Group
The subjects will choose their own mask and masking practices.
|
Treatment Group
The treatment group will receive and use the focal mask.
Focal Mask: The treatment group will receive and use the focal mask.
|
|---|---|---|
|
Pre-Treatment
The participant was in quarantine at start of study and contracted COVID-19.
|
1
|
0
|
Baseline Characteristics
Reducing Spread of COVID-19 in a University Community Setting: Role of a Low-Cost Reusable Form-Fitting Fabric Mask
Baseline characteristics by cohort
| Measure |
Control Group
n=100 Participants
The subjects will choose their own mask and masking practices.
|
Treatment Group
n=100 Participants
The treatment group will receive and use the focal mask.
Focal Mask: The treatment group will receive and use the focal mask.
|
Total
n=200 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
18 years
n=99 Participants
|
18 years
n=107 Participants
|
18 years
n=206 Participants
|
|
Sex/Gender, Customized
Male
|
49 Participants
n=99 Participants
|
49 Participants
n=107 Participants
|
98 Participants
n=206 Participants
|
|
Sex/Gender, Customized
Female
|
50 Participants
n=99 Participants
|
47 Participants
n=107 Participants
|
97 Participants
n=206 Participants
|
|
Sex/Gender, Customized
Prefer Not to Say
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Sex/Gender, Customized
Non-binary
|
0 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
9 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
90 Participants
n=99 Participants
|
93 Participants
n=107 Participants
|
183 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
56 Participants
n=99 Participants
|
48 Participants
n=107 Participants
|
104 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
30 Participants
n=99 Participants
|
41 Participants
n=107 Participants
|
71 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
11 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 4 weeksNumber of participants not infected by COVID-19 in a university setting.
Outcome measures
| Measure |
Control Group
n=100 Participants
The subjects will choose their own mask and masking practices.
|
Treatment Group
n=100 Participants
The treatment group will receive and use the focal mask.
Focal Mask: The treatment group will receive and use the focal mask.
|
|---|---|---|
|
Number of Participants Not Infected by COVID-19
|
100 Participants
|
100 Participants
|
Adverse Events
Control Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Treatment Group
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
Dr. Sundaresan Jayaraman
Georgia Institute of Technology
Phone: 404.894.2461
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place