A Trial of Two Mask Systems in Preventing SARS CoV-2 in Healthcare Workers (HCW)

Ascend Performance Materials

Status: Unknown

Conditions: Influenza -Like Illness; SARS CoV-2 Infection

Treatments: Device: Comparison Masks; Device: Acteev™ Masks

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT05036941

APM/AM/001

Details and patient eligibility

About

A cluster randomized trial will be conducted to evaluate the difference between an Acteev™ system (Acteev™ N95 masks YQD8008 during shifts+ Acteev™ fabric masks in community) and a standard system (standard N95 masks during shifts+ fabric masks in community) in preventing Severe Acute Respiratory Syndrome Coronavirus 2 (SARS CoV-2)in healthcare workers(HCWs).

Full description

This is a maximum 10-week (8-week intervention+2-week follow up) two-armed controlled study to investigate efficacy of Acteev™ system (Acteev™ N95 masks YQD8008 during shifts+ Acteev™ fabric masks in community) compared with standard system (standard N95 masks during shifts+ fabric masks in community) in HCWs working in high-risk hospital wards (ICU, emergency), against the prevention of SARS CoV-2 infection. Prospective HCWs will be identified for the study by the study investigator/study team and be invited for participation in the study. All study procedures will begin only after obtaining written informed consent from the subjects. Subjects will be randomized in one of the two arms mentioned below after meeting all the study eligibility criteria: Arm 1:Acteev™ system (Acteev™ N95 masks YQD8008 during shifts+ Acteev™ fabric masks in community) Arm 2: Standard system (standard N95 masks during shifts+ fabric masks in community).

Enrollment: 1,600 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Health care workers and allied health care staff working in COVID wards, COVID ICU, Non COVID ICU (This will include all specialty ICUs in the hospital), Casualty/Emergency, Operation Theatre and Pathology lab of the hospital
• Health care workers and allied health care staff involved in performing high risk procedures like suctioning, intubation, nebulized medications, chest physiotherapy, other aerosol generating procedures and handling pathology samples
• Negative COVID 19 RT-PCR test within last 3 days of screening
• COVID 19 vaccinated or non-vaccinated

Exclusion criteria

• Unable or refused to consent
• Current respiratory illness, rhinitis and/or allergy
• Currently participating in any other clinical trial
• Beard or facial hair

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,600 participants in 2 patient groups

Arm 1

Experimental group

Description:

Acteev™ system (Acteev™ N95 masks YQD8008 during shifts+ Acteev™ fabric masks in community)

Treatment:

Device: Acteev™ Masks

Arm 2

Active Comparator group

Description:

Standard system (standard N95 masks during shifts+ fabric masks in community)

Treatment:

Device: Comparison Masks