UnknownNot Applicable

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

India1,600 participantsStarted 2021-11-13

Plain-language 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).

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

The efficacy of Acteev™ system vs standard system in preventing SARS CoV-2 infection in health care workers

Timeframe: 8 weeks of wearing the masks (with the option of increasing to 12 weeks) with 2 weeks of following up.

Trial details

NCT IDNCT05036941

SponsorAscend Performance Materials

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-02

Contact for this trial

Neelambari Bhosale

+91-9823783443 neelambari@jcdc.co.in

View on ClinicalTrials.gov More SARS CoV-2 Infection trials