Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04647305 |
| Other study ID # |
1010166518 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 16, 2021 |
| Est. completion date |
March 4, 2021 |
Study information
| Verified date |
April 2021 |
| Source |
University of Los Andes, Columbia |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
The CoVIDA project is a study that follows up participants for 21 days and has enrolled more
than 33,667 participants since April 2020. The study has included participants whose
occupations have high mobility in the community, such as police, military, firefighters,
private and public service drivers, shopkeepers, domiciliary, and private security guards,
among others. Participants are mostly between 30 and 39 years old, followed by 20 to 29 years
old, and there is a lower proportion of the elder population. As of November 24, 2020, from
the total of 33,667 participants included in this epidemiological surveillance, 4.35%
presented a positive result for the SARS -CoV-2 RT-PCR test.
The present non-inferiority randomized controlled trial aims to determine the effectiveness
and adherence of closed face shields plus face mask use compared to face mask use only to
prevent SARS -CoV-2 transmission in working adults of Bogota, Colombia.
Methods
Non-inferiority randomized controlled trial nested within a cohort, with a parallel design of
1:1 allocation ratio. Study participants will be recruited through the CoVIDA project that
enrolls working adults in Bogota as part of the COVID-19 epidemiologic surveillance. Those
who consent to participate in the trial will be randomized for a group wearing closed face
shield plus face masks or a group wearing face masks only. Participants will also receive an
educational intervention about COVID-19 prevention and the proper use of face shields and
face masks. The intervention will last 21 days and includes a COVID-19 symptoms report and
verification of protective elements use (adherence). The RT-PCR test and antibody test will
be repeated on day 21. A total sample size of 194 participants, 97 per arm, is required to be
80% sure that the upper limit of a one-sided 95% confidence interval (or equivalently a 90%
two-sided confidence interval) will exclude a difference in favor of the standard group of
more than 5%. If 20% of rejects or losses to follow-up are considered, 233 will be recruited.
