Effectiveness and Adherence to Closed Face Shields to Prevent COVID-19 Transmission

NCT04647305 | Completed DMC

• 1 other identifier: 1010166518
• Study Type: interventional
• Target: 233
• Locations: 1 country
• Sites: 1

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.

Conditions

SARS-CoV-2 Infection

Keywords

Face shield; Visor; Adherence; Prevention; COVID-19; SARS-CoV-2 infection; Controlled Clinical Trial; Seroprevalence

Outcome Measures

Primary Outcomes (1)

• COVID-19 incidence

  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.

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

Secondary Outcomes (3)

• 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.

Study Arms (2)

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).

Other: Closed face shield with Surgical face mask use

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).

Other: Surgical face mask use only

Interventions

Closed face shield with Surgical face mask use OTHER

Use of a closed face shield with a surgical face mask during daily activities. The educational intervention will provide recommendations on COVID-19 prevention and proper use of the closed face shield and the surgical face masks.

Closed face shield + Surgical face mask

Surgical face mask use only OTHER

Use of a surgical face mask during daily activities. The educational intervention will provide recommendations on COVID-19 prevention and the proper use of surgical face masks.

Surgical face mask

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Los Andes, Columbia: lead
• United Nations: collaborator

Study Sites (1)

Universidad de los Andes

Bogotá, Colombia

Location

Related Publications (2)

• Varela AR, Gurruchaga AP, Restrepo SR, Martin JD, Landazabal YDC, Tamayo-Cabeza G, Contreras-Arrieta S, Caballero-Diaz Y, Florez LJH, Gonzalez JM, Santos-Barbosa JC, Pinzon JD, Yepes-Nunez JJ, Laajaj R, Buitrago Gutierrez G, Florez MV, Fuentes Castillo J, Quinche Vargas G, Casas A, Medina A, Behrentz E; CoVIDA Working Group. Effectiveness and adherence to closed face shields in the prevention of COVID-19 transmission: a non-inferiority randomized controlled trial in a middle-income setting (COVPROSHIELD). Trials. 2022 Aug 20;23(1):698. doi: 10.1186/s13063-022-06606-0.

  PMID: 35987694 DERIVED

• Pizarro AB, Persad E, Durao S, Nussbaumer-Streit B, Engela-Volker JS, McElvenny D, Rhodes S, Stocking K, Fletcher T, Martin C, Noertjojo K, Sampson O, Verbeek JH, Jorgensen KJ, Bruschettini M. Workplace interventions to reduce the risk of SARS-CoV-2 infection outside of healthcare settings. Cochrane Database Syst Rev. 2022 May 6;5(5):CD015112. doi: 10.1002/14651858.CD015112.pub2.

  PMID: 35514111 DERIVED

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

Study Officials

• Alejandro Pacheco Gurruchaga, MSc

  United Nations

  PRINCIPAL INVESTIGATOR

• Juan D. Martin, MSc

  United Nations

  PRINCIPAL INVESTIGATOR

• Luis J. Hernandez Florez, PhD

  University of Los Andes, School of Medicine

  STUDY CHAIR

• Juan J. Yepes Nuñez, PhD

  University of Los Andes, School of Medicine

  STUDY CHAIR

• Giancarlo Buitrago Gutierrez, PhD

  University of Los Andes

  PRINCIPAL INVESTIGATOR

• Rachid Laajaj, PhD

  University of Los Andes

  PRINCIPAL INVESTIGATOR

• Eduardo Behrentz, PhD

  University of Los Andes

  STUDY DIRECTOR

• José D. Pinzón, MSc

  Pontificia Universidad Javeriana

  PRINCIPAL INVESTIGATOR

• Jhon M. Gonzalez, PhD

  University of Los Andes, School of Medicine

  PRINCIPAL INVESTIGATOR

• Silvia Restrepo Restrepo, PhD

  University of Los Andes

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Epidemiology

Study Record Dates

• First Submitted: November 24, 2020
• First Posted: November 30, 2020
• Study Start: January 16, 2021
• Primary Completion: March 4, 2021
• Study Completion: March 4, 2021
• Last Updated: April 27, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 6 months after publication
• Access Criteria: A formal request sent to the principal investigator.

Locations

CO (1)