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| Name | Class |
|---|---|
| Jehangir Clinical Development Centre Pvt. Ltd. | UNKNOWN |
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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).
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental | Acteev™ system (Acteev™ N95 masks YQD8008 during shifts+ Acteev™ fabric masks in community) |
|
| Arm 2 | Active Comparator | Standard system (standard N95 masks during shifts+ fabric masks in community) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Neelambari Bhosale | Contact | +91-9823783443 | neelambari@jcdc.co.in | |
| Pathik Divate | Contact | +91-9325668979 | pathik@jcdc.co.in |
| Name | Affiliation | Role |
|---|---|---|
| Raina MacIntyre, MD | The University of New South Wales | Principal Investigator |
| Vikram Gopal, PhD | Ascend Performance Materials | Principal Investigator |
| Yantao Z Hughes, PhD |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jehangir Clinical Development Centre (JCDC) Pvt. Ltd | Recruiting | Pune | Maharashtra | 411001 | India |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25903751 | Background | 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. | |
| 32373326 | 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. |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| 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. |
|
| 8 weeks of wearing the masks (with the option of increasing to 12 weeks) with 2 weeks of following up |
| Ascend Performance Materials |
| Principal Investigator |
| 25560001 | 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. |
| 30880701 | 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. |
| 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 |
| 21477136 | 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. |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |