Clinical trial NCT06158724: COVID-19 Personal Protective Equipment for Vaccinated Health Workers and Convalescents
Official title: COVID-19 Personal Protective Equipment for Vaccinated Health Workers and Convalescents
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Covid19
Keywords: Covid19
SARS-CoV 2
Personal Protective Equipment
Safety
Lead sponsor: University Medical Centre Ljubljana
Sponsor class: OTHER
First posted: 2023-12-06
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Volunteer healthy healthcare workers working in COVID-19 departments.

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Non-inferiority of simplified PPE compared to standard PPE regarding symptomatic infection rate.
timeFrame: 30 days
Secondary outcomes:
measure: Non-inferiority of simplified PPE compared to standard PPE regarding asymptomatic infection rate.
timeFrame: 30 days
measure: Rise in anti-SARS-CoV 2 antibody titers in the simplified PPE group.
timeFrame: 30 days
Other outcomes:
Locations:
city: Ljubljana
country: Slovenia
facility: University Medical Center Ljubljana
Study officials:
References:
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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.