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

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ClinicalTrials.gov Identifier: NCT05036941
Recruitment Status : Not yet recruiting
First Posted : September 8, 2021
Last Update Posted : September 14, 2021
Sponsor:
Collaborator:
Jehangir Clinical Development Centre Pvt. Ltd.
Information provided by (Responsible Party):
Ascend Performance Materials

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).

Condition or disease Intervention/treatment Phase
SARS CoV-2 Infection Influenza -Like Illness Device: Acteev™ Masks Device: Comparison Masks Not Applicable

Detailed Description:
This is a maximum 10-week (8-week intervention+2-week follow up) (with the option of extending for another 4 weeks if needed) 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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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
Estimated Study Start Date : September 2021
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


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 or 12 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 or 12 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.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05036941


Contacts
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Contact: Neelambari Bhosale +91-9823783443 neelambari@jcdc.co.in
Contact: Pathik Divate +91-9325668979 pathik@jcdc.co.in

Sponsors and Collaborators
Ascend Performance Materials
Jehangir Clinical Development Centre Pvt. Ltd.
Investigators
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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:
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

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Responsible Party: Ascend Performance Materials
ClinicalTrials.gov Identifier: NCT05036941    
Other Study ID Numbers: APM/AM/001
First Posted: September 8, 2021    Key Record Dates
Last Update Posted: September 14, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ascend Performance Materials:
Clinical respiratory illness (CRI)
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases