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Clinical Trials/NCT04647305
NCT04647305CompletedNot Applicable

Effectiveness and Adherence to Closed Face Shields to Prevent COVID-19 Transmission: A Randomized Controlled Trial

University of Los Andes, Columbia1 site in 1 country233 target enrollmentStarted: January 16, 2021Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
233
Locations
1
Primary Endpoint
COVID-19 incidence

Study Overview

Brief Summary

A non-inferiority randomized controlled trial that aims to determine the effectiveness and adherence of the use of closed-face shields and surgical face masks in comparison with the use of surgical face masks for the prevention of SARS-CoV-2 infection in working adults in the city of Bogota, Colombia.

Detailed Description

Introduction

According to the Johns Hopkins University coronavirus resource center, COVID-19 has caused more than 1,399,373 deaths globally (as of November 24, 2020), and more than 59 million cases have been reported worldwide. Governments have been forced to establish various preventive measures to control transmission in the communities. The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is transmitted among close contacts mainly via respiratory droplets generated when an infected person coughs or sneezes. Likewise, airborne transmission through fomites/aerosols have been described due to the persistence of SARS-CoV-2 on different surfaces and the environment. SARS-CoV-2 causes the coronavirus disease 2019 (COVID-19), the respiratory illness responsible for the ongoing COVID-19 pandemic.

Physical distancing, face mask use, and eye protection had affected stopping SARS-CoV-2 transmission. While there is evidence of the use of face masks as a strategy to control respiratory infections and prevent the inhalation of large droplets and sprays, there is a need to determine the effectiveness of closed-face shields to prevent transmission in community settings. Despite the available reports, none of the randomized clinical trials have been conducted in the community setting. Although scarce, there is promising evidence showing that using face shields may bring an extra benefit in protecting airborne diseases, like COVID-19. Face shields have the benefits of preventing constant contact between face and hands, preventing airflow with possible infected particles from reaching the face, and protecting the eyes.

As of November 24, 2020, more than 1,254,979 cases have been reported in Colombia, and more than 35,479 deaths have occurred (a fatality rate of 2.83%). So far, no massive seroprevalence studies have been carried out in Colombia, that would determine the presence of Immunoglobulin G (IgG) and Immunoglobulin M (IgM) anti-SARS-CoV-2 antibodies, therefore, the level of immunity of the population and the likelihood of further waves of the disease. The first study to determine seroprevalence in Colombia found that, in a sample of 1368 people on the Caribbean coast of Colombia, 55.3% of the participants had anti-SARS-CoV-2 antibodies. The study of seroprevalence that is currently implemented by the Colombian National Institute of Health has not yet yielded results. Bogota, the country's capital district, has the highest number of confirmed cases compared to other departments and cities, but no studies have been conducted to determine what is level of immunity in the city´s population.

Therefore, epidemiological surveillance strategies are carried out to identify asymptomatic and symptomatic patients, trace contacts, and isolate cases to break transmission chains. As a result, an initiative called the CoVIDA project, which enrolls several institutions from academia to hospitals and the health authorities has emerged to support the epidemiological surveillance system of the city. This strategy is based on reverse transcription polymerase chain reaction (RT-PCR) testing for SARS-Cov-2 detection in populations that, because of their work and high mobility in public places, are at high risk of infection and spread of the virus and has contributed to inform the health authorities and help them in the effective decision-making for public policy management.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •Age 18 years or older
  • •Negative RT-PCR test at the beginning of the study.
  • •Negative SARS-CoV-2 serological Elecsys Anti-Sars-CoV-2 test at the beginning of the study.
  • •Living in a geographic area with active COVID-19 transmission (number of
  • •cases reported locally).
  • •Living in a geographic area that has been determined by the Colombian National Statistics Department (DANE) to have a medium, medium-high, and high vulnerability index (higher prevalence of comorbidities and social and economic vulnerabilities.
  • •Working outside the home for at least two days a week, during the last week.
  • •Acceptance to participate in the study regardless of the trial arm assignment through verbal informed consent.

Exclusion Criteria

  • •Retired adults or unemployed
  • •Adults referring previous diagnosis of COVID-19 confirmed by RT-PCR tests or serological antibody tests.

Arms & Interventions

Closed face shield + Surgical face mask

Experimental

Each participant will wear 21 surgical face masks corresponding to the follow-up days in the randomized clinical trial, as well as one closed face shield. Additionally, each participant will receive an educational intervention (video).

Intervention: Closed face shield with Surgical face mask use (Other)

Surgical face mask

Active Comparator

Each participant will wear 21 surgical face masks corresponding to the follow-up days in the randomized clinical trial. Additionally, each participant will receive an educational intervention (video).

Intervention: Surgical face mask use only (Other)

Outcomes

Primary Outcomes

COVID-19 incidence

Time Frame: 21 days of follow-up, RT-PCR test at day 21

The numerator will be the number of cases or the number of persons with laboratory evidence of present infection. In this case, a person with a positive result of a RT-PCR test for SARS-CoV-2 detection. The denominator will be the number of persons allocated in the determined group. Incidence of SARS-CoV-2 infection has been used as a risk measure in several studies, in which comparison groups are made. This risk measure will also allow the calculation of association measures such as RR (relative risk) in both intervention groups.

Secondary Outcomes

  • Adherence to closed face shields use(21 days of follow-up)
  • Percentage of participants with a positive serological test at baseline(Serological test at day 1)
  • Percentage of seroconversion in the experimental group and active control group(Serological test at day 21.)

Investigators

Sponsor
University of Los Andes, Columbia
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Andrea Ramirez Varela

Assistant Professor of Epidemiology

University of Los Andes, Columbia

Study Sites (1)

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