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

NCT ID: NCT05036941

Last Updated: 2021-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

1600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-13

Study Completion Date

2022-02-28

Brief Summary

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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

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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).

Conditions

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SARS CoV-2 Infection Influenza -Like Illness

Keywords

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Clinical respiratory illness (CRI)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Arm 1

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

Group Type EXPERIMENTAL

Acteev™ Masks

Intervention Type DEVICE

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.

Arm 2

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

Group Type ACTIVE_COMPARATOR

Comparison Masks

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type 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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Jehangir Clinical Development Centre Pvt. Ltd.

UNKNOWN

Sponsor Role collaborator

Ascend Performance Materials

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Raina MacIntyre, MD

Role: PRINCIPAL_INVESTIGATOR

University of New South Wales, Sydney, AUSTRALIA

Vikram Gopal, PhD

Role: PRINCIPAL_INVESTIGATOR

Ascend Performance Materials

Yantao Z Hughes, PhD

Role: PRINCIPAL_INVESTIGATOR

Ascend Performance Materials

Locations

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Jehangir Clinical Development Centre (JCDC) Pvt. Ltd

Pune, Maharashtra, India

Site Status RECRUITING

Countries

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India

Central Contacts

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Neelambari Bhosale

Role: CONTACT

Phone: +91-9823783443

Email: [email protected]

Pathik Divate

Role: CONTACT

Phone: +91-9325668979

Email: [email protected]

Facility Contacts

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Neelambari Bhosale

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 25903751 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32373326 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25560001 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30880701 (View on PubMed)

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

Reference Type BACKGROUND

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.

Reference Type BACKGROUND
PMID: 21477136 (View on PubMed)

Other Identifiers

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APM/AM/001

Identifier Type: -

Identifier Source: org_study_id