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WithdrawnNCT06158724Updated Dec 20, 2024

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

An observational study in Covid19, sponsored by University Medical Centre Ljubljana. Withdrawn at 1 site in Slovenia. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-12-20.

Sponsored by University Medical Centre Ljubljana · Observational

Why this study was withdrawn
COVID stopped
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
0
Ages
18 Years to 50 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Covid19

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Keywords

  • Covid19
  • SARS-CoV 2
  • Personal Protective Equipment
  • Safety
03

In context

COVID-19

7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.

Browse COVID-19 studies →

Lead sponsor

University Medical Centre Ljubljana is the lead sponsor of 284 studies on the registry; 71 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Volunteer healthy healthcare workers working in COVID-19 departments.

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

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
0 participants (actual)
Patient registry
No

Groups and cohorts

  • Simplified PPE group

    Surgical mask, standard non sealing goggles, use of protective gown while in direct contact with patients.

    Other: Personal Protective Equipment

  • 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.

Interventions

  • OtherPersonal Protective Equipment

    Simplified PPE for use in COVID-19 departments.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 30 days

Secondary outcomes

  1. 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.

    Time frame: 30 days

  2. Rise in anti-SARS-CoV 2 antibody titers in the simplified PPE group.

    Time frame: 30 days

07

Study locations

1 site
  • University Medical Center Ljubljana
    Ljubljana, 1525, Slovenia
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References and documents

Publications

  • Gross JV, Mohren J, Erren TC. COVID-19 and healthcare workers: a rapid systematic review into risks and preventive measures. BMJ Open. 2021 Jan 20;11(1):e042270. doi: 10.1136/bmjopen-2020-042270. PubMed 33472783 ↗
  • Sewell HF, Agius RM, Kendrick D, Stewart M. Covid-19 vaccines: delivering protective immunity. BMJ. 2020 Dec 17;371:m4838. doi: 10.1136/bmj.m4838. No abstract available. PubMed 33334862 ↗
  • Polack FP, Thomas SJ, Kitchin N, Absalon J, Gurtman A, Lockhart S, Perez JL, Perez Marc G, Moreira ED, Zerbini C, Bailey R, Swanson KA, Roychoudhury S, Koury K, Li P, Kalina WV, Cooper D, Frenck RW Jr, Hammitt LL, Tureci O, Nell H, Schaefer A, Unal S, Tresnan DB, Mather S, Dormitzer PR, Sahin U, Jansen KU, Gruber WC; C4591001 Clinical Trial Group. Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine. N Engl J Med. 2020 Dec 31;383(27):2603-2615. doi: 10.1056/NEJMoa2034577. Epub 2020 Dec 10. PubMed 33301246 ↗
  • Widge AT, Rouphael NG, Jackson LA, Anderson EJ, Roberts PC, Makhene M, Chappell JD, Denison MR, Stevens LJ, Pruijssers AJ, McDermott AB, Flach B, Lin BC, Doria-Rose NA, O'Dell S, Schmidt SD, Neuzil KM, Bennett H, Leav B, Makowski M, Albert J, Cross K, Edara VV, Floyd K, Suthar MS, Buchanan W, Luke CJ, Ledgerwood JE, Mascola JR, Graham BS, Beigel JH; mRNA-1273 Study Group. Durability of Responses after SARS-CoV-2 mRNA-1273 Vaccination. N Engl J Med. 2021 Jan 7;384(1):80-82. doi: 10.1056/NEJMc2032195. Epub 2020 Dec 3. No abstract available. PubMed 33270381 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 20, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06158724
Lead sponsor
University Medical Centre Ljubljana
Responsible party
Peter Radsel (asist. prof. Peter Radšel, MD, PhD., Head of intensive internal medicine department, University Medical Centre Ljubljana) — Principal investigator
First posted
Dec 6, 2023
Start date
Mar 1, 2021 (estimated)
Primary completion
Apr 1, 2021 (estimated)
Completion
May 1, 2021 (estimated)
Last update
Dec 20, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.

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