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

Target enrollment

201 participants

Primary outcome timeframe

4 weeks

Results posted on

2023-04-03

Participant Flow

Participant milestones

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

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

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=5 Participants	18 years n=7 Participants	18 years n=5 Participants
Sex/Gender, Customized Male	49 Participants n=5 Participants	49 Participants n=7 Participants	98 Participants n=5 Participants
Sex/Gender, Customized Female	50 Participants n=5 Participants	47 Participants n=7 Participants	97 Participants n=5 Participants
Sex/Gender, Customized Prefer Not to Say	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Sex/Gender, Customized Non-binary	0 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	9 Participants n=5 Participants	7 Participants n=7 Participants	16 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	90 Participants n=5 Participants	93 Participants n=7 Participants	183 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	56 Participants n=5 Participants	48 Participants n=7 Participants	104 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) White	30 Participants n=5 Participants	41 Participants n=7 Participants	71 Participants n=5 Participants
Race (NIH/OMB) More than one race	11 Participants n=5 Participants	8 Participants n=7 Participants	19 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants

PRIMARY outcome

Timeframe: 4 weeks

Number of participants not infected by COVID-19 in a university setting.

Outcome measures

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