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NCT06158724 Clinical Trial

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

Covid19 Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT06158724
Other study ID # CIIM-KIBVS COVID
Secondary ID
Status Withdrawn
Phase
First received
Last updated
Start date March 1, 2021
Est. completion date May 1, 2021

Study information
Verified date December 2023
Source University Medical Centre Ljubljana
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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 randomiyed observational trial with volunteer medical staff working in COVID-19 departments aiming to show non-inferiority of simplified PPE vs standard COVID-19 PPE.

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-purifiying 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.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date May 1, 2021
Est. primary completion date April 1, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 50 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Other:
• Personal Protective Equipment
Simplified PPE for use in COVID-19 departments.

Locations
Country Name City State
Slovenia University Medical Center Ljubljana Ljubljana

Sponsors (1)
Lead Sponsor Collaborator
University Medical Centre Ljubljana

Country where clinical trial is conducted

Slovenia, 

References & 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary 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 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
Secondary Rise in anti-SARS-CoV 2 antibody titers in the simplified PPE group. 30 days
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