COVID-19 Personal Protective Equipment for Vaccinated Health Workers and Convalescents
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Non-inferiority of simplified PPE compared to standard PPE regarding symptomatic infection rate.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Non-inferiority of simplified PPE compared to standard PPE regarding symptomatic infection rate.
时间窗: 30 days
The use of simplified PPE will not predispose COVID-19 immune healthcare workers to symptomatic neoinfection.
次要结局
- Non-inferiority of simplified PPE compared to standard PPE regarding asymptomatic infection rate.(30 days)
- Rise in anti-SARS-CoV 2 antibody titers in the simplified PPE group.(30 days)
研究者
Peter Radsel
asist. prof. Peter Radšel, MD, PhD., Head of intensive internal medicine department
University Medical Centre Ljubljana