Influenza -Like Illness, SARS CoV-2 Infection
Conditions
Keywords
Clinical respiratory illness (CRI)
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).
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).
Interventions
DEVICEActeev™ 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.
DEVICEComparison 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.
Sponsors
Jehangir Clinical Development Centre Pvt. Ltd.
Ascend Performance Materials
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The efficacy of Acteev™ system vs standard system in preventing SARS CoV-2 infection in health care workers | 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | • 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) |
Countries
India
Contacts
Primary ContactNeelambari Bhosale
Backup ContactPathik Divate
Outcome results
None listed