We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Try the New Site
We're building a modernized ClinicalTrials.gov! Visit Beta.ClinicalTrials.gov to try the new functionality.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

The Respiratory Protection Effectiveness Clinical Trial (ResPECT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01249625
Recruitment Status : Completed
First Posted : November 30, 2010
Results First Posted : April 25, 2019
Last Update Posted : April 25, 2019
Sponsor:
Collaborators:
Centers for Disease Control and Prevention
US Department of Veterans Affairs
University of Massachusetts, Amherst
Denver Health and Hospital Authority
Children's Hospital Colorado
VA Eastern Colorado Health Care System
VA New York Harbor Healthcare System
Michael E. DeBakey VA Medical Center
Washington D.C. Veterans Affairs Medical Center
VA St. Louis Health Care System
Information provided by (Responsible Party):
Johns Hopkins University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Conditions Influenza
Respiratory Syncytial Viruses
Paramyxoviridae Infections
Coronavirus
Rhinovirus
Interventions Device: N95 Respirator
Device: Medical/surgical mask
Enrollment 2862
Recruitment Details participants were recruited from outpatient settings considered at high risk for respiratory illnesses (emergency rooms, internal medicine and pediatric clinics) and had to work at least 24 hours per week in a given setting. They had to have face to face exposure to patients and be willing and able to participate, sign informed consent.
Pre-assignment Details  
Arm/Group Title N95 Respirator Medical/Surgical Mask
Hide Arm/Group Description

The investigators are comparing the selected N95 respirators against the selected medical mask.

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

The investigators are comparing the selected medical/surgical mask against the N95 respirator.

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.

Period Title: Overall Study
Started 1374 1488
Completed 1374 1488
Not Completed 0 0
Arm/Group Title N95 Respirator Medical/Surgical Mask Total
Hide Arm/Group Description

The investigators are comparing the selected N95 respirators against the selected medical mask.

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

The investigators are comparing the selected medical/surgical mask against the N95 respirator.

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.

Total of all reporting groups
Overall Number of Baseline Participants 1374 1488 2862
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1374 participants 1488 participants 2862 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
1347
  98.0%
1451
  97.5%
2798
  97.8%
>=65 years
27
   2.0%
37
   2.5%
64
   2.2%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 1374 participants 1488 participants 2862 participants
43  (0.6) 43  (0.5) 43  (0.55)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1374 participants 1488 participants 2862 participants
Female
1149
  83.6%
1220
  82.0%
2369
  82.8%
Male
225
  16.4%
268
  18.0%
493
  17.2%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1374 participants 1488 participants 2862 participants
Hispanic or Latino
212
  15.4%
227
  15.3%
439
  15.3%
Not Hispanic or Latino
1151
  83.8%
1245
  83.7%
2396
  83.7%
Unknown or Not Reported
11
   0.8%
16
   1.1%
27
   0.9%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1374 participants 1488 participants 2862 participants
American Indian or Alaska Native
9
   0.7%
7
   0.5%
16
   0.6%
Asian
103
   7.5%
108
   7.3%
211
   7.4%
Native Hawaiian or Other Pacific Islander
2
   0.1%
6
   0.4%
8
   0.3%
Black or African American
371
  27.0%
431
  29.0%
802
  28.0%
White
731
  53.2%
761
  51.1%
1492
  52.1%
More than one race
50
   3.6%
57
   3.8%
107
   3.7%
Unknown or Not Reported
108
   7.9%
118
   7.9%
226
   7.9%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 1374 participants 1488 participants 2862 participants
1374
 100.0%
1488
 100.0%
2862
 100.0%
1.Primary Outcome
Title Protective Effects of N95 Respirators vs Medical Masks (MM) as Assessed by Number of Influenza A and B Events
Hide Description Number of influenza A and B events in healthcare practitioners wearing N95 respirators compared to medical masks.
Time Frame 60 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title N95 Respirator Medical/Surgical Mask
Hide Arm/Group Description:

The investigators are comparing the selected N95 respirators against the selected medical mask.

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

The investigators are comparing the selected medical/surgical mask against the N95 respirator.

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.

Overall Number of Participants Analyzed 1374 1488
Measure Type: Number
Unit of Measure: number of influenza A and B events
222 204
2.Secondary Outcome
Title Protective Effects of N95 Respirators vs Medical Masks as Assessed by Number of Influenza-like Illnesses
Hide Description Number of influenza-like illnesses in healthcare practitioners wearing N95 respirators compared to medical masks.
Time Frame 60 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title N95 Respirator Medical/Surgical Mask
Hide Arm/Group Description:

The investigators are comparing the selected N95 respirators against the selected medical mask.

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

The investigators are comparing the selected medical/surgical mask against the N95 respirator.

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.

Overall Number of Participants Analyzed 1374 1488
Measure Type: Number
Unit of Measure: number of influenza-like illnesses
128 166
3.Secondary Outcome
Title Protective Effects of N95 Respirators vs Medical Masks as Assessed by Number of Lab Confirmed Respiratory Illnesses
Hide Description Number of lab confirmed respiratory illnesses in healthcare practitioners wearing N95 respirators compared to medical masks.
Time Frame 60 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title N95 Respirator Medical/Surgical Mask
Hide Arm/Group Description:

The investigators are comparing the selected N95 respirators against the selected medical mask.

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

The investigators are comparing the selected medical/surgical mask against the N95 respirator.

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.

Overall Number of Participants Analyzed 1374 1488
Measure Type: Number
Unit of Measure: number of respiratory illnesses
371 417
4.Secondary Outcome
Title Protective Effects of N95 Respirators vs Medical Masks as Assessed by Number of Lab Detected Respiratory Infections
Hide Description Number of lab detected respiratory infections in healthcare practitioners wearing N95 respirators compared to medical masks.
Time Frame 60 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title N95 Respirator Medical/Surgical Mask
Hide Arm/Group Description:

The investigators are comparing the selected N95 respirators against the selected medical mask.

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

The investigators are comparing the selected medical/surgical mask against the N95 respirator.

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.

Overall Number of Participants Analyzed 1374 1488
Measure Type: Number
Unit of Measure: number of respiratory infections
679 745
5.Secondary Outcome
Title Protective Effects of N95 Respirators vs Medical Masks as Assessed by Number of Acute Respiratory Illnesses
Hide Description Number of acute respiratory illnesses in healthcare practitioners wearing N95 respirators compared to medical masks.
Time Frame 60 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title N95 Respirator Medical/Surgical Mask
Hide Arm/Group Description:

The investigators are comparing the selected N95 respirators against the selected medical mask.

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

The investigators are comparing the selected medical/surgical mask against the N95 respirator.

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.

Overall Number of Participants Analyzed 1374 1488
Measure Type: Number
Unit of Measure: number of acute respiratory illnesses
1556 1711
6.Secondary Outcome
Title Protective Effects of N95 Respirators vs Medical Masks as Assessed by Number of Laboratory Confirmed Illness
Hide Description Number of laboratory confirmed influenza illnesses in healthcare practitioners wearing N95 respirators compared to medical masks.
Time Frame 60 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title N95 Respirator Medical/Surgical Mask
Hide Arm/Group Description:

The investigators are comparing the selected N95 respirators against the selected medical mask.

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

The investigators are comparing the selected medical/surgical mask against the N95 respirator.

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.

Overall Number of Participants Analyzed 1374 1488
Measure Type: Number
Unit of Measure: Number of laboratory confirmed illnesses
207 193
Time Frame We collected adverse events (AEs) for each 12-week respiratory season (total of 4 seasons) while participants were actively wearing masks or respirators.
Adverse Event Reporting Description An AE is any adverse change from patient's baseline (pre-study) condition, which occurs during the course of the study, whether the event is considered to be related to the study intervention or not and documented in REDCap. Researchers assessed if the reported event meets the definition of an AE. Patients will be monitored until resolution. AEs were submitted to local Institutional Review Board according to their reporting policy. Participants reported symptoms in daily and weekly diaries.
 
Arm/Group Title N95 Respirator Medical/Surgical Mask
Hide Arm/Group Description

The investigators are comparing specific N95 respirator against specific medical masks.

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

The investigators are comparing medical/surgical masks against the N95 respirator.

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

All-Cause Mortality
N95 Respirator Medical/Surgical Mask
Affected / at Risk (%) Affected / at Risk (%)
Total   0/1374 (0.00%)      0/1488 (0.00%)    
Hide Serious Adverse Events
N95 Respirator Medical/Surgical Mask
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/1374 (0.00%)      0/1488 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
N95 Respirator Medical/Surgical Mask
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   19/1374 (1.38%)      0/1488 (0.00%)    
Skin and subcutaneous tissue disorders     
rash  [1]  19/1374 (1.38%)  19 0/1488 (0.00%)  0
Indicates events were collected by systematic assessment
[1]
skin irritation and worsening acne reported -- all events reported at one site in one respiratory virus season
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Trish Perl
Organization: University of Texas Southwestern
Phone: 214-648-9022
EMail: Trish.Perl@UTSouthwestern.edu
Publications:
U.S. Department of Health and Human Services: Food and Drug Administration (2005). Guidance for Industry: Collection of Race and Ethnicity Data in Clinical Trials. Rockville, MD: Food and Drug Administration.
Fisher LD, Dixon DO, Herson J, et al. (1990) Intention to treat in clinical trials. In: Peace KE (Ed.), Statistical issues in drug research and development (pp. 331-50). New York, NY: Marcel Dekker.
Hayes RJ and Moulton LH (2009) Cluster Randomised Trials. Chapman and Hall/CRC.
ICH Expert Working Group (1998). ICH Harmonised Tripartite Guideline, Statistical Principles for Clinical Trials E9, Current Step 4 version dated 5 February 1998. http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E9/Step4/E9_Guideline.pdf (last accessed 04 June 2017).
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01249625    
Other Study ID Numbers: NA_00031266
First Submitted: November 29, 2010
First Posted: November 30, 2010
Results First Submitted: April 3, 2019
Results First Posted: April 25, 2019
Last Update Posted: April 25, 2019