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

December 7, 2021 updated by: Ascend Performance Materials

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

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Anticipated)

1600

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • India
    • Maharashtra
      • Pune, Maharashtra, India, 411001
        • Recruiting
        • Jehangir Clinical Development Centre (JCDC) Pvt. Ltd
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Arm 1
Acteev™ system (Acteev™ N95 masks YQD8008 during shifts+ Acteev™ 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.
ACTIVE_COMPARATOR: Arm 2
Standard system (standard N95 masks during shifts+ fabric masks in community)
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The efficacy of Acteev™ system vs standard system in preventing SARS CoV-2 infection in health care workers
Time Frame: 8 weeks of wearing the masks (with the option of increasing to 12 weeks) with 2 weeks of following up.
• 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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
The efficacy of Acteev™ system vs standard system in preventing CRI/ILI infection in healthcare workers
Time Frame: 8 weeks of wearing the masks (with the option of increasing to 12 weeks) with 2 weeks of following up
• Number of cases with Clinical Respiratory illness defined as two or more respiratory symptoms or one respiratory symptom and/or a systemic symptom along with laboratory-confirmed viral and bacterial respiratory infection other than SARS CoV 2 (Including respiratory syncytial virus (RSV), human metapneumovirus(hMPV), influenza A (H3N2), (H1N1) pdm09, influenza B, parainfluenza viruses 1-4, influenza C, rhinoviruses, severe acute respiratory syndrome (SARS) associated coronavirus (SARS-CoV), coronaviruses 229E, NL63,OC43 and HKU1, adenoviruses and Bacteria like Bordetella pertussis, Bordetella parapertussis, Chlamydia pneumoniae, Mycoplasma pneumoniae)
8 weeks of wearing the masks (with the option of increasing to 12 weeks) with 2 weeks of following up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ascend Performance Materials

Collaborators

Jehangir Clinical Development Centre Pvt. Ltd.

Investigators

  • Principal Investigator: 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 13, 2021

Primary Completion (ANTICIPATED)

February 1, 2022

Study Completion (ANTICIPATED)

February 1, 2022

Study Registration Dates

First Submitted

August 26, 2021

First Submitted That Met QC Criteria

September 2, 2021

First Posted (ACTUAL)

September 8, 2021

Study Record Updates

Last Update Posted (ACTUAL)

December 22, 2021

Last Update Submitted That Met QC Criteria

December 7, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • APM/AM/001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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