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

Withdrawn

• Conditions: Covid19
• Interventions: Other: Personal Protective Equipment

• Registration Number: NCT06158724
• Lead Sponsor: University Medical Centre Ljubljana

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.

Study Timeline

• Study Start: 2021-03-01
• Primary Completion: 2021-04-01
• Study Completion: 2021-05-01
• Study First Submitted: 2023-12-05
• Study First Submitted QC: 2023-12-05
• Study First Posted: 2023-12-06
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-17
• Last Update Posted: 2024-12-20

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Simplified PPE group	Personal Protective Equipment	Surgical mask, standard non sealing goggles, use of protective gown while in direct contact with patients.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

University Medical Center Ljubljana; 🇸🇮 Ljubljana, Slovenia