The Respiratory Protection Effectiveness Clinical Trial (ResPECT)
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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
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Study Type | Interventional |
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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 |
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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 | |
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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 | |
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[Not Specified]
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Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 1374 participants | 1488 participants | 2862 participants | |
<=18 years |
0 0.0%
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0 0.0%
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0 0.0%
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Between 18 and 65 years |
1347 98.0%
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1451 97.5%
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2798 97.8%
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>=65 years |
27 2.0%
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37 2.5%
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64 2.2%
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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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 |
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Number Analyzed | 1374 participants | 1488 participants | 2862 participants | |
Female |
1149 83.6%
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1220 82.0%
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2369 82.8%
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Male |
225 16.4%
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268 18.0%
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493 17.2%
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Ethnicity (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 1374 participants | 1488 participants | 2862 participants | |
Hispanic or Latino |
212 15.4%
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227 15.3%
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439 15.3%
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Not Hispanic or Latino |
1151 83.8%
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1245 83.7%
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2396 83.7%
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Unknown or Not Reported |
11 0.8%
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16 1.1%
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27 0.9%
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Race (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 1374 participants | 1488 participants | 2862 participants | |
American Indian or Alaska Native |
9 0.7%
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7 0.5%
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16 0.6%
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Asian |
103 7.5%
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108 7.3%
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211 7.4%
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Native Hawaiian or Other Pacific Islander |
2 0.1%
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6 0.4%
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8 0.3%
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Black or African American |
371 27.0%
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431 29.0%
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802 28.0%
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White |
731 53.2%
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761 51.1%
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1492 52.1%
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More than one race |
50 3.6%
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57 3.8%
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107 3.7%
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Unknown or Not Reported |
108 7.9%
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118 7.9%
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226 7.9%
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Region of Enrollment
Measure Type: Count of Participants Unit of measure: Participants |
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United States | Number Analyzed | 1374 participants | 1488 participants | 2862 participants |
1374 100.0%
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1488 100.0%
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2862 100.0%
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Name/Title: | Dr. Trish Perl |
Organization: | University of Texas Southwestern |
Phone: | 214-648-9022 |
EMail: | Trish.Perl@UTSouthwestern.edu |
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 |