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

NCT05036941 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1600

Last updated 2021-12-22

No results posted yet for this study

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).

Conditions

  • SARS CoV-2 Infection
  • Influenza -Like Illness

Interventions

DEVICE

Acteev™ 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.

DEVICE

Comparison 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 & Collaborators

  • Jehangir Clinical Development Centre Pvt. Ltd.

    collaborator UNKNOWN

  • Ascend Performance Materials

    lead INDUSTRY

Principal Investigators

  • Raina MacIntyre, MD · University of New South Wales, Sydney, AUSTRALIA

  • Vikram Gopal, PhD · Ascend Performance Materials

  • Yantao Z Hughes, PhD · Ascend Performance Materials

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-11-13
Primary Completion
2022-02-28
Completion
2022-02-28

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05036941 on ClinicalTrials.gov