Reducing Spread of COVID-19 in a University Community Setting: Role of a Low-Cost Reusable Form-Fitting Fabric Mask

NCT04979858 | Completed Results FDA Device

• 2 other identifiers: H2121875D30121C10545
• Study Type: interventional
• Target: 201
• Locations: 1 country
• Sites: 1

Brief Summary

The primary aim of the proposed research is to test the role of a newly developed reusable form-fitting fabric mask in reducing the spread of COVID-19 in a community setting comprising undergraduate students living in dormitories at the Georgia Institute of Technology (Georgia Tech). A corollary aim is to assess the role of wearing any type of face covering in reducing spread in the same community setting. A final aim is to assess the social, behavioral, aesthetic, and usability aspects of wearing face coverings in public settings.

Conditions

Covid19; SARS-CoV2 Infection

Keywords

Reusable masks; University Setting

Outcome Measures

Primary Outcomes (1)

• Number of Participants Not Infected by COVID-19

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

  4 weeks

Study Arms (2)

Control Group

NO INTERVENTION

The subjects will choose their own mask and masking practices.

Treatment Group

EXPERIMENTAL

The treatment group will receive and use the focal mask.

Device: Focal Mask

Interventions

Focal Mask DEVICE

The treatment group will receive and use the focal mask.

Treatment Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Georgia Institute of Technology (Georgia Tech) student
• years old or older
• Living on campus in Georgia Tech dorms

You may not qualify if:

• Not a Georgia Tech student
• Under the age of 18
• Not living on campus in Georgia Tech dorms

Sponsors & Collaborators

• Georgia Institute of Technology: lead

Study Sites (1)

Georgia Institute of Technology - Main Campus

Atlanta, Georgia, 30332, United States

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Limitations and Caveats

To simulate a "real" community setting in which individual behaviors cannot be specified, monitored, or controlled, regular health diagnostic testing for COVID-19 during the study was not mandated for the subjects. Therefore, subjects who became infected, but were asymptomatic, would not have been tested; as a result, there is a potential for undercounting the number of reported positive cases during the study.

Results Point of Contact

• Title: Dr. Sundaresan Jayaraman
• Organization: Georgia Institute of Technology

sundaresan.jayaraman@gatech.edu

404.894.2461

Study Officials

• Sundaresan Jayaraman, Ph.D

  Georgia Institute of Technology

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: The PI will not know which subjects have been assigned to which arm.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: One group will receive the focal mask and the other group will choose its own mask.

Study Record Dates

• First Submitted: July 22, 2021
• First Posted: July 28, 2021
• Study Start: September 6, 2021
• Primary Completion: October 30, 2021
• Study Completion: March 15, 2022
• Last Updated: April 3, 2023
• Results First Posted: April 3, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)