Trial Outcomes & Findings for Acute Safety and Acceptability Study of Experimental Device RD19 for Protection From Human Respiratory Disease Pathogens (NCT NCT04557826)
NCT ID: NCT04557826
Last Updated: 2024-10-03
Results Overview
* Ease of device use (Likert Scale 1 -10) * Clarity of user instructions (Likert Scale 1-10) * Compliance with per protocol schedule (# times missed / 28) and, if out of compliance, reason(s) for noncompliance (collected as verbal string).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
25 participants
Primary outcome timeframe
14 consecutive days of RD19 device use per protocol
Results posted on
2024-10-03
Participant Flow
Participant milestones
| Measure |
RD19 Experimental Device
RD19 Experimental Device used twice/day for 3 minutes each use at least 4 hours, and preferably 8-12 hours, apart
RD19: Experimental device that uses safe electromagnetic energy to stimulate the proximal repository of respiratory tract infectious disease pathogens
|
|---|---|
|
Overall Study
STARTED
|
25
|
|
Overall Study
COMPLETED
|
25
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Acute Safety and Acceptability Study of Experimental Device RD19 for Protection From Human Respiratory Disease Pathogens
Baseline characteristics by cohort
| Measure |
RD19 Experimental Device
n=25 Participants
RD19 Experimental Device used twice/day for 3 minutes each use at least 4 hours, and preferably 8-12 hours, apart
RD19: Experimental device that uses safe electromagnetic energy to stimulate the proximal repository of respiratory tract infectious disease pathogens
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
25 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
16 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
25 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 14 consecutive days of RD19 device use per protocol* Ease of device use (Likert Scale 1 -10) * Clarity of user instructions (Likert Scale 1-10) * Compliance with per protocol schedule (# times missed / 28) and, if out of compliance, reason(s) for noncompliance (collected as verbal string).
Outcome measures
| Measure |
RD19 Experimental Device
n=25 Participants
RD19 Experimental Device used twice/day for 3 minutes each use at least 4 hours, and preferably 8-12 hours, apart
RD19: Experimental device that uses safe electromagnetic energy to stimulate the proximal repository of respiratory tract infectious disease pathogens
|
|---|---|
|
RD19 Acceptability
I Did Not Have Any Problems Using The Device Full Assessment Period (Day 7) · Not recorded
|
1 Participants
|
|
RD19 Acceptability
I Did Not Have Any Problems Using The Device Full Assessment (Day 14) · Strongly Disagree
|
0 Participants
|
|
RD19 Acceptability
I Did Not Have Any Problems Using The Device Full Assessment (Day 14) · Disagree
|
2 Participants
|
|
RD19 Acceptability
I Did Not Have Any Problems Using The Device Full Assessment Period (Day 7) · Strongly Disagree
|
1 Participants
|
|
RD19 Acceptability
I Did Not Have Any Problems Using The Device Full Assessment Period (Day 7) · Disagree
|
0 Participants
|
|
RD19 Acceptability
I Did Not Have Any Problems Using The Device Full Assessment Period (Day 7) · Neutral
|
1 Participants
|
|
RD19 Acceptability
I Did Not Have Any Problems Using The Device Full Assessment Period (Day 7) · Agree
|
9 Participants
|
|
RD19 Acceptability
I Did Not Have Any Problems Using The Device Full Assessment Period (Day 7) · Strongly Agree
|
13 Participants
|
|
RD19 Acceptability
I Did Not Have Any Problems Using The Device Full Assessment (Day 14) · Neutral
|
0 Participants
|
|
RD19 Acceptability
I Did Not Have Any Problems Using The Device Full Assessment (Day 14) · Agree
|
6 Participants
|
|
RD19 Acceptability
I Did Not Have Any Problems Using The Device Full Assessment (Day 14) · Strongly Agree
|
15 Participants
|
|
RD19 Acceptability
I Did Not Have Any Problems Using The Device Full Assessment (Day 14) · Not recorded
|
2 Participants
|
Adverse Events
RD19 Experimental Device
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
RD19 Experimental Device
n=25 participants at risk
RD19 Experimental Device used twice/day for 3 minutes each use at least 4 hours, and preferably 8-12 hours, apart
RD19: Experimental device that uses safe electromagnetic energy to stimulate the proximal repository of respiratory tract infectious disease pathogens
|
|---|---|
|
Nervous system disorders
Headache
|
28.0%
7/25 • Number of events 7 • 14 days
|
|
Gastrointestinal disorders
Dysphagia
|
12.0%
3/25 • Number of events 3 • 14 days
|
|
Gastrointestinal disorders
Nausea
|
8.0%
2/25 • Number of events 2 • 14 days
|
|
Gastrointestinal disorders
Oral Disorder
|
8.0%
2/25 • Number of events 2 • 14 days
|
|
Gastrointestinal disorders
Dry Mouth
|
4.0%
1/25 • Number of events 1 • 14 days
|
|
Gastrointestinal disorders
Dry throat
|
4.0%
1/25 • Number of events 1 • 14 days
|
|
General disorders
Application Site Pain
|
24.0%
6/25 • Number of events 6 • 14 days
|
|
General disorders
Application Site Erythema
|
16.0%
4/25 • Number of events 4 • 14 days
|
|
General disorders
Application Site Swelling
|
4.0%
1/25 • Number of events 1 • 14 days
|
|
Vascular disorders
Dizziness
|
4.0%
1/25 • Number of events 1 • 14 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee All study data and reports of study data are the property of the study sponsor. The sponsor my grant the PI the right to publish the results of this research in a scientific journal, conditional upon the review and concurrence of the sponsor.
- Publication restrictions are in place
Restriction type: OTHER