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

December 17, 2024 updated by: Peter Radsel, University Medical Centre Ljubljana

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Slovenia
      • Ljubljana, Slovenia, 1525
        • University Medical Center Ljubljana

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Volunteer healthy healthcare workers working in COVID-19 departments.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Simplified PPE group
Surgical mask, standard non sealing goggles, use of protective gown while in direct contact with patients.
Other: Personal Protective Equipment
Simplified PPE for use in COVID-19 departments.
Standard COVID-19 PPE

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?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Non-inferiority of simplified PPE compared to standard PPE regarding symptomatic infection rate.
Time Frame: 30 days
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.
Time Frame: 30 days
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.
Time Frame: 30 days
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Medical Centre Ljubljana

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2021

Primary Completion (Estimated)

April 1, 2021

Study Completion (Estimated)

May 1, 2021

Study Registration Dates

First Submitted

December 5, 2023

First Submitted That Met QC Criteria

December 5, 2023

First Posted (Actual)

December 6, 2023

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 17, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CIIM-KIBVS COVID

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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