None listed
Conditions
Interventions
Intervention1: ActeevTM system which includes ActeevTM N95 masks YQD8008 during shifts and ActeevTM fabric masks in community.: Participants in Arms 1 will wear ActeevTM N95 masks YQD8008 during 8-hou
Sponsors
Ascend Performance Materials Operations LLC
Eligibility
Inclusion criteria
Inclusion criteria: A subject will be considered eligible for inclusion in this study only if ALL of the following criteria apply: 1.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 to be considered for recruitment. 2.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 to be considered for recruitment 3.Negative COVID 19 RT-PCR test within last 3 days of screening 4.COVID 19 vaccinated or non-vaccinated.
Exclusion criteria
Exclusion criteria: A subject will not be eligible for inclusion in this study if ANY of the following criteria apply: 1.Unable or refused to consent 2.Current respiratory illness, rhinitis and/or allergy 3.Currently participating in any other clinical trial 4.Beard or facial hair
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 symptomTimepoint: Test will be repeated every 2 weeks to identify the number of cases with SARS CoV 2 infection | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.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 to 4, influenza C, rhinoviruses, severe acute respiratory syndrome (SARS) associated coronavirus (SARS CoV), coronaviruses 229E, NL63,OC43 and HKU1, adenoviruses and Bacteria Bordetella pertussis, Bordetella parapertussis, Chlamydia pneumoniae, Mycoplasma pneumoniae). 2.Adverse events related to wearing a mask, a safety issue (Skin rash, difficulty breathing, pressure on nose, allergies or any other event reported by participant). 3.Poor adherence with mask wearing Drug-consumption/Concomitant medication, in particular antibiotics. 4.Sick-leave from work Timepoint: Test will be performed only if patient have symptoms & SARS CoV 2 test is negative | — |
Countries
India
Contacts
Public ContactDr Vikram Gopal
Ascend Performance Materials Operations LLC
Outcome results
None listed