The Respiratory Protection Effectiveness Clinical Trial

Summary

Despite widespread use of respiratory protective equipment in the U.S. healthcare workplace, there is very little clinical evidence that respirators prevent healthcare personnel (HCP) from airborne infectious diseases. Scientific investigation of this issue has been quite complicated, primarily because the use of respirators has become "the standard of care" for protection against airborne diseases in some instances, even without sufficient evidence to support their use. The key question remains: How well do respirators prevent airborne infectious diseases? The answer to this important question has important medical, public health, political and economic implications.

Conditions

• Influenza
• Respiratory Syncytial Viruses
• Paramyxoviridae Infections
• Coronavirus
• Rhinovirus

Interventions

DEVICE

N95 Respirator

Participants in this arm will be asked to wear an N95 respirator for the extent of the 12 week study period.

DEVICE

Medical/surgical mask

Participants in this arm will be asked to wear a medical/surgical mask for the extent of the 12 week study period.

Sponsors & Collaborators

• Centers for Disease Control and Prevention

  collaborator FED

• US Department of Veterans Affairs

  collaborator FED

• University of Massachusetts, Amherst

  collaborator OTHER

• Denver Health and Hospital Authority

  collaborator OTHER

• Children's Hospital Colorado

  collaborator OTHER

• VA Eastern Colorado Health Care System

  collaborator FED

• VA New York Harbor Healthcare System

  collaborator FED

• Michael E. DeBakey VA Medical Center

  collaborator FED

• Washington D.C. Veterans Affairs Medical Center

  collaborator FED

• VA St. Louis Health Care System

  collaborator FED

• Johns Hopkins University

  lead OTHER

Principal Investigators

• Trish M. Perl, MD · UTSouthwestern Medical Center

• Lewis Radonovich, MD · CDC-NIOSH

• Derek Cummings, PhD · University of Florida

• Michael Simberkoff, MD · New York Harbor Healthcare System VA

• Connie S Price, MD · University of Colorado (Denver Health)

• Charlotte Gaydos, PhD · Johns Hopkins University

• Nicholas Reich, PhD · University of Massachusetts, Amherst

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

100 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2010-12-31

Primary Completion

2018-03-31

Completion

2018-03-31

Countries

• United States

Study Locations