Trial Outcomes & Findings for The Respiratory Protection Effectiveness Clinical Trial (NCT NCT01249625)
NCT ID: NCT01249625
Last Updated: 2019-04-25
Results Overview
Number of influenza A and B events in healthcare practitioners wearing N95 respirators compared to medical masks.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
2862 participants
Primary outcome timeframe
60 weeks
Results posted on
2019-04-25
Participant Flow
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.
Participant milestones
| Measure |
N95 Respirator
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.
|
Medical/Surgical Mask
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 Study
STARTED
|
1374
|
1488
|
|
Overall Study
COMPLETED
|
1374
|
1488
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Respiratory Protection Effectiveness Clinical Trial
Baseline characteristics by cohort
| Measure |
N95 Respirator
n=1374 Participants
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.
|
Medical/Surgical Mask
n=1488 Participants
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
n=2862 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1347 Participants
n=5 Participants
|
1451 Participants
n=7 Participants
|
2798 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
27 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
64 Participants
n=5 Participants
|
|
Age, Continuous
|
43 years
STANDARD_DEVIATION 0.6 • n=5 Participants
|
43 years
STANDARD_DEVIATION 0.5 • n=7 Participants
|
43 years
STANDARD_DEVIATION 0.55 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1149 Participants
n=5 Participants
|
1220 Participants
n=7 Participants
|
2369 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
225 Participants
n=5 Participants
|
268 Participants
n=7 Participants
|
493 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
212 Participants
n=5 Participants
|
227 Participants
n=7 Participants
|
439 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1151 Participants
n=5 Participants
|
1245 Participants
n=7 Participants
|
2396 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
11 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
9 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
103 Participants
n=5 Participants
|
108 Participants
n=7 Participants
|
211 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
2 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
371 Participants
n=5 Participants
|
431 Participants
n=7 Participants
|
802 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
731 Participants
n=5 Participants
|
761 Participants
n=7 Participants
|
1492 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
50 Participants
n=5 Participants
|
57 Participants
n=7 Participants
|
107 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
108 Participants
n=5 Participants
|
118 Participants
n=7 Participants
|
226 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
1374 Participants
n=5 Participants
|
1488 Participants
n=7 Participants
|
2862 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 60 weeksNumber of influenza A and B events in healthcare practitioners wearing N95 respirators compared to medical masks.
Outcome measures
| Measure |
Medical/Surgical Mask
n=1488 Participants
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.
|
N95 Respirator
n=1374 Participants
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.
|
|---|---|---|
|
Protective Effects of N95 Respirators vs Medical Masks (MM) as Assessed by Number of Influenza A and B Events
|
204 number of influenza A and B events
|
222 number of influenza A and B events
|
SECONDARY outcome
Timeframe: 60 weeksNumber of influenza-like illnesses in healthcare practitioners wearing N95 respirators compared to medical masks.
Outcome measures
| Measure |
Medical/Surgical Mask
n=1488 Participants
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.
|
N95 Respirator
n=1374 Participants
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.
|
|---|---|---|
|
Protective Effects of N95 Respirators vs Medical Masks as Assessed by Number of Influenza-like Illnesses
|
166 number of influenza-like illnesses
|
128 number of influenza-like illnesses
|
SECONDARY outcome
Timeframe: 60 weeksNumber of lab confirmed respiratory illnesses in healthcare practitioners wearing N95 respirators compared to medical masks.
Outcome measures
| Measure |
Medical/Surgical Mask
n=1488 Participants
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.
|
N95 Respirator
n=1374 Participants
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.
|
|---|---|---|
|
Protective Effects of N95 Respirators vs Medical Masks as Assessed by Number of Lab Confirmed Respiratory Illnesses
|
417 number of respiratory illnesses
|
371 number of respiratory illnesses
|
SECONDARY outcome
Timeframe: 60 weeksNumber of lab detected respiratory infections in healthcare practitioners wearing N95 respirators compared to medical masks.
Outcome measures
| Measure |
Medical/Surgical Mask
n=1488 Participants
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.
|
N95 Respirator
n=1374 Participants
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.
|
|---|---|---|
|
Protective Effects of N95 Respirators vs Medical Masks as Assessed by Number of Lab Detected Respiratory Infections
|
745 number of respiratory infections
|
679 number of respiratory infections
|
SECONDARY outcome
Timeframe: 60 weeksNumber of acute respiratory illnesses in healthcare practitioners wearing N95 respirators compared to medical masks.
Outcome measures
| Measure |
Medical/Surgical Mask
n=1488 Participants
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.
|
N95 Respirator
n=1374 Participants
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.
|
|---|---|---|
|
Protective Effects of N95 Respirators vs Medical Masks as Assessed by Number of Acute Respiratory Illnesses
|
1711 number of acute respiratory illnesses
|
1556 number of acute respiratory illnesses
|
SECONDARY outcome
Timeframe: 60 weeksNumber of laboratory confirmed influenza illnesses in healthcare practitioners wearing N95 respirators compared to medical masks.
Outcome measures
| Measure |
Medical/Surgical Mask
n=1488 Participants
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.
|
N95 Respirator
n=1374 Participants
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.
|
|---|---|---|
|
Protective Effects of N95 Respirators vs Medical Masks as Assessed by Number of Laboratory Confirmed Illness
|
193 Number of laboratory confirmed illnesses
|
207 Number of laboratory confirmed illnesses
|
Adverse Events
N95 Respirator
Serious events: 0 serious events
Other events: 19 other events
Deaths: 0 deaths
Medical/Surgical Mask
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
N95 Respirator
n=1374 participants at risk
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.
|
Medical/Surgical Mask
n=1488 participants at risk
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.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
rash
|
1.4%
19/1374 • Number of events 19 • We collected adverse events (AEs) for each 12-week respiratory season (total of 4 seasons) while participants were actively wearing masks or respirators.
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.
|
0.00%
0/1488 • We collected adverse events (AEs) for each 12-week respiratory season (total of 4 seasons) while participants were actively wearing masks or respirators.
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.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place