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COVID stopped
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Personal Protective Equipment | Other | Simplified PPE for use in COVID-19 departments. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 30 days |
| Rise in anti-SARS-CoV 2 antibody titers in the simplified PPE group. |
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Inclusion Criteria:
Exclusion Criteria:
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Volunteer healthy healthcare workers working in COVID-19 departments.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Medical Center Ljubljana | Ljubljana | 1525 | Slovenia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33472783 | Background | 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. | |
| 33334862 | Background | 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. |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D000067393 | Personal Protective Equipment |
| ID | Term |
|---|---|
| D011482 | Protective Devices |
| D004864 | Equipment and Supplies |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
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| 30 days |
| 33301246 | Background | 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. |
| 33270381 | Background | 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. |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |