Study Stopped
COVID stopped
COVID-19 Personal Protective Equipment for Vaccinated Health Workers and Convalescents
1 other identifier
observational
N/A
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Mar 2021
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2021
CompletedFirst Submitted
Initial submission to the registry
December 5, 2023
CompletedFirst Posted
Study publicly available on registry
December 6, 2023
CompletedDecember 20, 2024
December 1, 2024
1 month
December 5, 2023
December 17, 2024
Conditions
Keywords
Outcome Measures
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.
30 days
Secondary Outcomes (2)
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
Study Arms (2)
Simplified PPE group
Surgical mask, standard non sealing goggles, use of protective gown while in direct contact with patients.
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
Simplified PPE for use in COVID-19 departments.
Eligibility Criteria
Volunteer healthy healthcare workers working in COVID-19 departments.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Medical Center Ljubljana
Ljubljana, 1525, Slovenia
Related Publications (4)
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.
PMID: 33472783BACKGROUNDSewell 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.
PMID: 33334862BACKGROUNDPolack 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.
PMID: 33301246BACKGROUNDWidge 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.
PMID: 33270381BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- asist. prof. Peter Radšel, MD, PhD., Head of intensive internal medicine department
Study Record Dates
First Submitted
December 5, 2023
First Posted
December 6, 2023
Study Start
March 1, 2021
Primary Completion
April 1, 2021
Study Completion
May 1, 2021
Last Updated
December 20, 2024
Record last verified: 2024-12