Covid19
Conditions
Keywords
Covid19, SARS-CoV 2, Personal Protective Equipment, Safety
Brief summary
The aim of the trial is to assess the safety of using simplified personal protective equipment (PPE) for vaccinated or COVID-19 convalescent healthcare workers working in COVID-19 ICU or COVID-19 wards. The trial is designed as a prospective randomized observational trial with volunteer medical staff working in COVID-19 departments aiming to show non-inferiority of simplified PPE vs standard COVID-19 PPE.
Detailed description
Objectives To assess safety of simplified personal protective equipment (PPE) for vaccinated health workers and COVID-19 convalescents - pilot trial. Methods Prospective randomized observational trial. 60 participants randomized 1:1 to either standard PPE (COVID-19 ward: FFP2 or higher respirator, goggles of face shield, gown, gloves; COVID-19 ICU: FFP3 respirator and tight goggles or full face mask or powered air-purifying respirators, gown and gloves) or simplified PPE (surgical mask, goggles or face shield, gown). 30 days follow up period. Participants Volunteer medical staff from COVID-19 regular and ICU departments at University Medical Center Ljubljana, Slovenia, with either proven COVID-19 infection within 6 months or at least 7 days after second dose anti COIVD-19 vaccine. Hypotheses Simplified PPE is non-inferior to standard PPE in vaccinated health workers or convalescents. Discussion Positive study results may decrease PPE spending cost and positively affect working conditions at COVID-19 departments.
Interventions
OTHERPersonal Protective Equipment
Simplified PPE for use in COVID-19 departments.
Sponsors
University Medical Centre Ljubljana
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* age \< 50 years * prior COVID-19 infection; time from infection \< 6 months. * prior completed anti COVID-19 immunization; \> 1 week post second dose of immunization. * signed written consent * negative nasopharyngeal COVID-19 RT-PCR test
Exclusion criteria
* age \> 50 years * time post COVID-19 infection \> 6 months * time post COVID-19 immunization \< 1 week. * immunocompromised patients * pregnancy * CKD 3 or more * COPD or other lung disease * heart failure of any cause * ischemic heart disease * obesity (BMI \> 30) * DM on therapy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Non-inferiority of simplified PPE compared to standard PPE regarding symptomatic infection rate. | 30 days | The use of simplified PPE will not predispose COVID-19 immune healthcare workers to symptomatic neoinfection. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Non-inferiority of simplified PPE compared to standard PPE regarding asymptomatic infection rate. | 30 days | No difference in nasopharyngeal RT-PCR SARS-CoV 2 results between groups. |
| Rise in anti-SARS-CoV 2 antibody titers in the simplified PPE group. | 30 days | — |
Countries
Slovenia
Outcome results
None listed