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

University Medical Centre Ljubljana

Status: Withdrawn

Conditions: Covid19

Treatments: Other: Personal Protective Equipment

Study type: Observational

Funder types: Other

Identifiers

NCT06158724

CIIM-KIBVS COVID

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

0 participants in 2 patient groups

Simplified PPE group

Description:

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

Treatment:

Other: Personal Protective Equipment

Standard COVID-19 PPE

Description:

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.