SARS CoV-2 InfectionNCT05036941
A Trial of Two Mask Systems in Preventing SARS CoV-2 in Healthcare Workers (HCW)
A study testing Acteev™ Masks and Comparison Masks in people with SARS CoV-2 Infection and Influenza -Like Illness, run by Ascend Performance Materials at 1 site in India.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- SARS CoV-2 Infection, Influenza -Like Illness
- What is being tested?
- Acteev™ Masks and Comparison Masks
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,600 participants
- Where
- 1 siteIndia
- Study dates
- 13 Nov 2021to Feb 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Unable or refused to consent
- Current respiratory illness, rhinitis and/or allergy
- Currently participating in any other clinical trial
- Beard or facial hair
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
Jehangir Clinical Development Centre (JCDC) Pvt. Ltd
Pune, Maharashtra, 411001
Neelambari Bhosale, +91 9823783443, neelambari@jcdc.co.in
About this study
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
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).
Read the 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).
- Conditions
- SARS CoV-2 Infection, Influenza -Like Illness
- Being tested
- Acteev™ Masks, Comparison Masks
- Keywords
- Clinical respiratory illness (CRI)
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acteev™ MasksDevice
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.
Comparison MasksDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Acteev™ system (Acteev™ N95 masks YQD8008 during shifts+ Acteev™ fabric masks in community) Receives: Device: Acteev™ Masks |
| Arm 2 | Active comparator | Standard system (standard N95 masks during shifts+ fabric masks in community) Receives: Device: Comparison Masks |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
- 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)
Measured: 8 weeks of wearing the masks (with the option of increasing to 12 weeks) with 2 weeks of following up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2021
- Study start13 Nov 2021
- Primary completionFeb 2022 (estimated)
- Study completionFeb 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for SARS CoV-2 InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ascend Performance Materials
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Jehangir Clinical Development Centre Pvt. Ltd.
- Responsible party
- Sponsor
- Investigators
- Raina MacIntyre, MD, Principal investigator, The University of New South WalesVikram Gopal, PhD, Principal investigator, Ascend Performance MaterialsYantao Z Hughes, PhD, Principal investigator, Ascend Performance Materials
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05036941
- Sponsor's protocol ID
- APM/AM/001
- Status last verified
- Dec 2021
- First submitted
- 26 Aug 2021
- Last updated
- 22 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 25903751Narayan 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.
PubMed 32373326Chavan 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.
PubMed 25560001Mudhigeti 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.
PubMed 30880701Gopal 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
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.
PubMed 21477136
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05036941
- Acronym / sponsor ID
- APM/AM/001
- Conditions
- SARS CoV-2 Infection, Influenza -Like Illness
- Keywords
- Clinical respiratory illness (CRI)
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,600 participants (estimated)
- Lead sponsor
- Ascend Performance MaterialsIndustry (pharma, biotech, devices)
- Collaborators
- Jehangir Clinical Development Centre Pvt. Ltd.
- Study start
- 13 Nov 2021 (actual)
- Primary completion
- Feb 2022 (estimated)
- Study completion
- Feb 2022 (estimated)
- First posted
- 8 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Device: Acteev™ MasksActeev™ system (Acteev™ N95 masks YQD8008 during shifts+ Acteev™ fabric masks in community) |
| Arm 2 | Active comparator | Device: Comparison MasksStandard system (standard N95 masks during shifts+ fabric masks in community) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- Unable or refused to consent
- Current respiratory illness, rhinitis and/or allergy
- Currently participating in any other clinical trial
- Beard or facial hair
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acteev™ MasksParticipants 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. | Device | Arm 1 |
| Comparison MasksParticipants 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. | Device | Arm 2 |
Primary outcome
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
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2021.
- Background: PubMed 25903751MacIntyre 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.
- Background: PubMed 32373326Narayan 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.
- Background: PubMed 25560001Chavan 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.
- Background: PubMed 30880701Mudhigeti 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.
- BackgroundGopal 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: PubMed 21477136MacIntyre 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Raina MacIntyre, MD principal investigator
The University of New South Wales
Vikram Gopal, PhD principal investigator
Ascend Performance Materials
Yantao Z Hughes, PhD principal investigator
Ascend Performance Materials
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acteev™ Masks and Comparison Masks in people with SARS CoV-2 Infection and Influenza -Like Illness, run by Ascend Performance Materials at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Neelambari Bhosale (+91-9823783443, neelambari@jcdc.co.in), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05036941, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2021.