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临床试验/NCT04647305
NCT04647305已完成不适用

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

University of Los Andes, Columbia1 个研究点 分布在 1 个国家目标入组 233 人开始时间: 2021年1月16日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
233
试验地点
1
主要终点
COVID-19 incidence

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •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.

排除标准

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

研究组 & 干预措施

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).

干预措施: 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).

干预措施: Surgical face mask use only (Other)

结局指标

主要结局

COVID-19 incidence

时间窗: 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.

次要结局

  • 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.)

研究者

发起方
University of Los Andes, Columbia
申办方类型
Other
责任方
Principal Investigator
主要研究者

Andrea Ramirez Varela

Assistant Professor of Epidemiology

University of Los Andes, Columbia

研究点 (1)

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