A cluster randomized trial will be conducted to evaluate the difference between anActeev™ system (Acteev™ N95 masks YQD8008 during shifts+ Acteev™ fabric masks incommunity) and a standard system (standard N95 masks during shifts+ fabric masks incommunity) in preventing Severe Acute Respiratory Syndrome Coronavirus 2 (SARS CoV-2)inhealthcare workers(HCWs).
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).
Device: Acteev™ Masks
Participants will wear the mask on every shift for 8 consecutive weeks. Participants in
Arm 1 will be supplied adequate number of Acteev™ N95 masks YQD8008 during 8-hour shift
and Acteev™ fabric masks for community use.
Device: Comparison Masks
Participants will wear the mask on every shift for 8 consecutive weeks. Participants in
Arm 2 will be supplied with adequate number of standard N95 masks during 8-hour shift and
fabric mask for community use.
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
Jehangir Clinical Development Centre (JCDC) Pvt. Ltd
Pune, Maharashtra, India
Investigator: Neelambari Bhosale
Contact: +91 9823783443
neelambari@jcdc.co.in
Neelambari Bhosale
+91-9823783443
neelambari@jcdc.co.in
Pathik Divate
+91-9325668979
pathik@jcdc.co.in