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

NCT05036941 | Unknown DMC

• 1 other identifier: APM/AM/001
• Study Type: interventional
• Target: 1,600
• Locations: 1 country
• Sites: 1

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).

Conditions

SARS CoV-2 Infection; Influenza -Like Illness

Keywords

Clinical respiratory illness (CRI)

Outcome Measures

Primary Outcomes (1)

• The efficacy of Acteev™ system vs standard system in preventing SARS CoV-2 infection in health care workers

  • Number of cases with laboratory-confirmed for viral SARS CoV 2 respiratory infection using RT-PCR with or without two or more respiratory symptoms or one respiratory symptom and/or a systemic symptom

  8 weeks of wearing the masks (with the option of increasing to 12 weeks) with 2 weeks of following up.

Secondary Outcomes (1)

• The efficacy of Acteev™ system vs standard system in preventing CRI/ILI infection in healthcare workers

  8 weeks of wearing the masks (with the option of increasing to 12 weeks) with 2 weeks of following up

Study Arms (2)

Arm 1

EXPERIMENTAL

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

Device: Acteev™ Masks

Arm 2

ACTIVE COMPARATOR

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

Device: Comparison Masks

Interventions

Acteev™ Masks 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 1

Comparison Masks 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.

Arm 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Ascend Performance Materials: lead
• Jehangir Clinical Development Centre Pvt. Ltd.: collaborator

Study Sites (1)

Jehangir Clinical Development Centre (JCDC) Pvt. Ltd

Pune, Maharashtra, 411001, India

RECRUITING

Related Publications (6)

• 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.

  PMID: 25903751 BACKGROUND

• 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.

  PMID: 32373326 BACKGROUND

• 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.

  PMID: 25560001 BACKGROUND

• 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.

  PMID: 30880701 BACKGROUND

• 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

  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.

  PMID: 21477136 BACKGROUND

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Raina MacIntyre, MD

  University of New South Wales, Sydney, AUSTRALIA

  PRINCIPAL INVESTIGATOR

• Vikram Gopal, PhD

  Ascend Performance Materials

  PRINCIPAL INVESTIGATOR

• Yantao Z Hughes, PhD

  Ascend Performance Materials

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Neelambari Bhosale

CONTACT

+91-9823783443; neelambari@jcdc.co.in

Pathik Divate

CONTACT

+91-9325668979; pathik@jcdc.co.in

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2021
• First Posted: September 8, 2021
• Study Start: November 13, 2021
• Primary Completion: February 1, 2022
• Study Completion: February 1, 2022
• Last Updated: December 22, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)