COVID-19 Personal Protective Equipment for Vaccinated Health Workers and Convalescents
NCT ID: NCT06158724
Last Updated: 2024-12-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
OBSERVATIONAL
2021-03-01
2021-05-01
Brief Summary
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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
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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.
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Simplified PPE group
Surgical mask, standard non sealing goggles, use of protective gown while in direct contact with patients.
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.
No interventions assigned to this group
Interventions
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Personal Protective Equipment
Simplified PPE for use in COVID-19 departments.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
50 Years
ALL
Yes
Sponsors
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University Medical Centre Ljubljana
OTHER
Responsible Party
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Peter Radsel
asist. prof. Peter Radšel, MD, PhD., Head of intensive internal medicine department
Locations
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University Medical Center Ljubljana
Ljubljana, , Slovenia
Countries
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References
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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.
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.
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.
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.
Other Identifiers
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CIIM-KIBVS COVID
Identifier Type: -
Identifier Source: org_study_id