Clinical trial NCT05036941: A Trial of Two Mask Systems in Preventing SARS CoV-2 in Healthcare Workers (HCW)
Official title: A Cluster Randomized Trial of Two Mask Systems (Acteev™ N95 + Acteev™ Fabric Masks vs. Standard N95 + Fabric Masks During Shifts & in Community) in Preventing Severe Acute Respiratory Syndrome Coronavirus 2 (SARS CoV-2) in HCWs
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: SARS CoV-2 Infection
Influenza -Like Illness
Keywords: Clinical respiratory illness (CRI)
Lead sponsor: Ascend Performance Materials
Sponsor class: INDUSTRY
Collaborators: name: Jehangir Clinical Development Centre Pvt. Ltd.
First posted: 2021-09-08
Enrollment: 1600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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).

Detailed 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).

Eligibility criteria: 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

Primary outcomes:
measure: The efficacy of Acteev™ system vs standard system in preventing SARS CoV-2 infection in health care workers
timeFrame: 8 weeks of wearing the masks (with the option of increasing to 12 weeks) with 2 weeks of following up.
Secondary outcomes:
measure: The efficacy of Acteev™ system vs standard system in preventing CRI/ILI infection in healthcare workers
timeFrame: 8 weeks of wearing the masks (with the option of increasing to 12 weeks) with 2 weeks of following up
Other outcomes:
Locations:
city: Pune
country: India
facility: Jehangir Clinical Development Centre (JCDC) Pvt. Ltd
state: Maharashtra
Study officials:
affiliation: University of New South Wales, Sydney, AUSTRALIA
name: Raina MacIntyre, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ascend Performance Materials
name: Vikram Gopal, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ascend Performance Materials
name: Yantao Z Hughes, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: MacIntyre CR, Seale H, Dung TC, Hien NT, Nga PT, Chughtai AA, Rahman B, Dwyer DE, Wang Q. A cluster randomised trial of cloth masks compared with medical masks in healthcare workers. BMJ Open. 2015 Apr 22;5(4):e006577. doi: 10.1136/bmjopen-2014-006577.
citation: Narayan VV, Iuliano AD, Roguski K, Bhardwaj R, Chadha M, Saha S, Haldar P, Kumar R, Sreenivas V, Kant S, Bresee J, Jain S, Krishnan A. Burden of influenza-associated respiratory and circulatory mortality in India, 2010-2013. J Glob Health. 2020 Jun;10(1):010402. doi: 10.7189/jogh.10.010402.
citation: Chavan RD, Kothari ST, Zunjarrao K, Chowdhary AS. Surveillance of acute respiratory infections in Mumbai during 2011-12. Indian J Med Microbiol. 2015 Jan-Mar;33(1):43-50. doi: 10.4103/0255-0857.148376.
citation: Mudhigeti N, Racherla RG, Mahalakshmi PA, Pamireddy ML, Nallapireddy U, Kante M, Kalawat U. A study of influenza 2017-2018 outbreak in Andhra Pradesh, India. Indian J Med Microbiol. 2018 Oct-Dec;36(4):526-531. doi: 10.4103/ijmm.IJMM_18_272.
citation: Gopal V, Nilsson-Payant BE, French H, et al. Zinc-embedded fabrics inactivate SARS-CoV-2 and influenza A virus. Preprint. bioRxiv. 2020;2020.11.02.365833. Published 2020 Nov 4. doi:10.1101/2020.11.02.365833
citation: MacIntyre CR, Wang Q, Cauchemez S, Seale H, Dwyer DE, Yang P, Shi W, Gao Z, Pang X, Zhang Y, Wang X, Duan W, Rahman B, Ferguson N. A cluster randomized clinical trial comparing fit-tested and non-fit-tested N95 respirators to medical masks to prevent respiratory virus infection in health care workers. Influenza Other Respir Viruses. 2011 May;5(3):170-9. doi: 10.1111/j.1750-2659.2011.00198.x. Epub 2011 Jan 27.