COVID-19 Personal Protective Equipment for Vaccinated Health Workers and Convalescents

Study Overview
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Brief Summary
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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 randomiyed 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
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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-purifiying 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.

Official Title
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COVID-19 Personal Protective Equipment for Vaccinated Health Workers and Convalescents

Conditions
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Covid19

Intervention / Treatment
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* Other: Personal Protective Equipment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Simplified PPE group<br>Surgical mask, standard non sealing goggles, use of protective gown while in direct contact with patients. | Other: Personal Protective Equipment<br>* Simplified PPE for use in COVID-19 departments.<br>|
| Standard COVID-19 PPE<br>FFP2 mask, goggles and face shield, protective gown for COVID-19 ward. FFP 3 mask or filter gas mask, sealing goggles, face shield or hazmat suit, protective gown, gloves and surgical cap. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Non-inferiority of simplified PPE compared to standard PPE regarding symptomatic infection rate. | The use of simplified PPE will not predispose COVID-19 immune healthcare workers to symptomatic neoinfection. | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Non-inferiority of simplified PPE compared to standard PPE regarding asymptomatic infection rate. | No difference in nasopharyngeal RT-PCR SARS-CoV 2 results between groups. | 30 days | 
| Rise in anti-SARS-CoV 2 antibody titers in the simplified PPE group. |  | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Covid19, SARS-CoV 2, Personal Protective Equipment, Safety