Trial Outcomes & Findings for Evaluation of the RD-X19 Treatment Device in Individuals With Mild COVID-19 (NCT NCT05817045)
NCT ID: NCT05817045
Last Updated: 2024-10-24
Results Overview
Each of eight symptoms (cough, sore throat, nasal congestion, headache, chills and or sweats, myalgia, fatigue, and nausea (with or without vomiting)) will be rated on a 4-point scale from none (0) to severe (3). Time to sustained resolution of COVID-19 signs and symptoms as measured by the time (in hours) when all eight symptoms have been assessed by the subject as none (0) or mild (1) and all symptoms remain at or below 1 until study Day 14. Subjects that are hospitalized will be censored at 360 hours, which corresponds to the end of the time window for the day 14 visit. A subject not satisfying case (i) or (ii), who takes nirmatrelvir/ritonavir or molnupiravir after initiating study treatment will be censored at the time that they first took this antiviral medication. Subjects not satisfying case (i), (ii), or (iii) will be censored at the last time that they have e-diary data recorded.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
330 participants
Primary outcome timeframe
Baseline through Day 14
Results posted on
2024-10-24
Participant Flow
Participant milestones
| Measure |
Active
RD-X19 Active Device
Investigational device that uses 32 J/cm2 of electromagnetic energy to target the oropharynx.
|
Sham
RD-X19 Sham Device
Investigational device that uses safe electromagnetic energy to target the oropharynx but at energy levels with a lower inactivation potential against SARS-CoV2 in vitro.
|
|---|---|---|
|
Overall Study
STARTED
|
162
|
168
|
|
Overall Study
COMPLETED
|
147
|
157
|
|
Overall Study
NOT COMPLETED
|
15
|
11
|
Reasons for withdrawal
| Measure |
Active
RD-X19 Active Device
Investigational device that uses 32 J/cm2 of electromagnetic energy to target the oropharynx.
|
Sham
RD-X19 Sham Device
Investigational device that uses safe electromagnetic energy to target the oropharynx but at energy levels with a lower inactivation potential against SARS-CoV2 in vitro.
|
|---|---|---|
|
Overall Study
Protocol Violation
|
0
|
3
|
|
Overall Study
Withdrawal by Subject
|
10
|
7
|
|
Overall Study
Physician Decision
|
3
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
|
Overall Study
Device Deficiency
|
1
|
0
|
|
Overall Study
System Error
|
1
|
0
|
Baseline Characteristics
Evaluation of the RD-X19 Treatment Device in Individuals With Mild COVID-19
Baseline characteristics by cohort
| Measure |
Active
n=161 Participants
RD-X19 Active Device
Investigational device that uses 32 J/cm2 of electromagnetic energy to target the oropharynx.
|
Sham
n=166 Participants
RD-X19 Sham Device
Investigational device that uses safe electromagnetic energy to target the oropharynx but at energy levels with a lower inactivation potential against SARS-CoV2 in vitro.
|
Total
n=327 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
54.39 years
STANDARD_DEVIATION 8.793 • n=93 Participants
|
55.56 years
STANDARD_DEVIATION 10.180 • n=4 Participants
|
54.98 years
STANDARD_DEVIATION 9.526 • n=27 Participants
|
|
Sex: Female, Male
Female
|
99 Participants
n=93 Participants
|
105 Participants
n=4 Participants
|
204 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
62 Participants
n=93 Participants
|
61 Participants
n=4 Participants
|
123 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
45 Participants
n=93 Participants
|
53 Participants
n=4 Participants
|
98 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
112 Participants
n=93 Participants
|
112 Participants
n=4 Participants
|
224 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
7 Participants
n=93 Participants
|
10 Participants
n=4 Participants
|
17 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
38 Participants
n=93 Participants
|
34 Participants
n=4 Participants
|
72 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
112 Participants
n=93 Participants
|
117 Participants
n=4 Participants
|
229 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
161 participants
n=93 Participants
|
166 participants
n=4 Participants
|
327 participants
n=27 Participants
|
|
Body Mass Index (BMI)
|
28.9498 Kg/m^2
STANDARD_DEVIATION 5.01187 • n=93 Participants
|
29.5443 Kg/m^2
STANDARD_DEVIATION 4.92951 • n=4 Participants
|
29.2525 Kg/m^2
STANDARD_DEVIATION 4.97137 • n=27 Participants
|
|
Total Baseline Disease Severity Score
|
1.4977 units on a scale
STANDARD_DEVIATION 0.46739 • n=93 Participants
|
1.4571 units on a scale
STANDARD_DEVIATION 0.45741 • n=4 Participants
|
1.4771 units on a scale
STANDARD_DEVIATION 0.46209 • n=27 Participants
|
|
COVID-19 vaccination status
Yes
|
122 Participants
n=93 Participants
|
118 Participants
n=4 Participants
|
240 Participants
n=27 Participants
|
|
COVID-19 vaccination status
No
|
38 Participants
n=93 Participants
|
45 Participants
n=4 Participants
|
83 Participants
n=27 Participants
|
|
COVID-19 vaccination status
Missing
|
1 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
|
Baseline Log10 nasopharyngeal viral load
|
6.2527 log 10 copies/mL
STANDARD_DEVIATION 1.44278 • n=93 Participants
|
6.2655 log 10 copies/mL
STANDARD_DEVIATION 1.53496 • n=4 Participants
|
6.2592 log 10 copies/mL
STANDARD_DEVIATION 1.48778 • n=27 Participants
|
|
SARS-CoV-2 antigen test type
Flowflex
|
86 Participants
n=93 Participants
|
93 Participants
n=4 Participants
|
179 Participants
n=27 Participants
|
|
SARS-CoV-2 antigen test type
BinaxNOW
|
75 Participants
n=93 Participants
|
73 Participants
n=4 Participants
|
148 Participants
n=27 Participants
|
|
Randomization Stratum
Age 40-49, Disease Severity Score < 1.25
|
9 Participants
n=93 Participants
|
10 Participants
n=4 Participants
|
19 Participants
n=27 Participants
|
|
Randomization Stratum
Age 40-49, Disease Severity Score >= 1.25
|
44 Participants
n=93 Participants
|
45 Participants
n=4 Participants
|
89 Participants
n=27 Participants
|
|
Randomization Stratum
Age >= 50, Disease Severity Score < 1.25
|
35 Participants
n=93 Participants
|
35 Participants
n=4 Participants
|
70 Participants
n=27 Participants
|
|
Randomization Stratum
Age >= 50, Disease Severity Score >= 1.25
|
73 Participants
n=93 Participants
|
76 Participants
n=4 Participants
|
149 Participants
n=27 Participants
|
|
Hours at screening since onset of first COVID-19 sign or symptoms
|
43.9 hours
STANDARD_DEVIATION 14.36 • n=93 Participants
|
40.8 hours
STANDARD_DEVIATION 15.09 • n=4 Participants
|
42.3 hours
STANDARD_DEVIATION 14.80 • n=27 Participants
|
|
Baseline Risk Factor Score
0
|
100 Participants
n=93 Participants
|
109 Participants
n=4 Participants
|
209 Participants
n=27 Participants
|
|
Baseline Risk Factor Score
1
|
44 Participants
n=93 Participants
|
33 Participants
n=4 Participants
|
77 Participants
n=27 Participants
|
|
Baseline Risk Factor Score
2
|
14 Participants
n=93 Participants
|
19 Participants
n=4 Participants
|
33 Participants
n=27 Participants
|
|
Baseline Risk Factor Score
3
|
3 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
|
Baseline Risk Factor Score
4
|
0 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Baseline Risk Factor Score
5
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Baseline Risk Factor Score
6
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Baseline Risk Factor Score
>6
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Baseline through Day 14Population: Full Analysis Set (FAS)
Each of eight symptoms (cough, sore throat, nasal congestion, headache, chills and or sweats, myalgia, fatigue, and nausea (with or without vomiting)) will be rated on a 4-point scale from none (0) to severe (3). Time to sustained resolution of COVID-19 signs and symptoms as measured by the time (in hours) when all eight symptoms have been assessed by the subject as none (0) or mild (1) and all symptoms remain at or below 1 until study Day 14. Subjects that are hospitalized will be censored at 360 hours, which corresponds to the end of the time window for the day 14. A subject not satisfying case (i) or (ii), who takes nirmatrelvir/ritonavir or molnupiravir after initiating study treatment will be censored at the time that they first took this antiviral medication. Subjects not satisfying case (i), (ii), or (iii) will be censored at the last time that they have e-diary data recorded.
Outcome measures
| Measure |
Active
n=161 Participants
RD-X19 Active Device
Investigational device that uses 32 J/cm2 of electromagnetic energy to target the oropharynx.
|
Sham
n=166 Participants
RD-X19 Sham Device
Investigational device that uses safe electromagnetic energy to target the oropharynx but at energy levels with a lower inactivation potential against SARS-CoV2 in vitro.
|
|---|---|---|
|
Number of Subjects With Sustained Resolution of COVID-19 Signs and Symptoms Without Subsequent Symptom Recurrence or Disease Progression (Until the End of the Study)
|
107 Participants
|
120 Participants
|
PRIMARY outcome
Timeframe: Baseline through Day 14Population: Full Analysis Set (FAS)
Each of eight symptoms (cough, sore throat, nasal congestion, headache, chills and or sweats, myalgia, fatigue, and nausea (with or without vomiting)) will be rated on a 4-point scale from none (0) to severe (3). Time to sustained resolution of COVID-19 signs and symptoms as measured by the time (in hours) when all eight symptoms have been assessed by the subject as none (0) or mild (1) and all symptoms remain at or below 1 until study Day 14. Subjects that are hospitalized will be censored at 360 hours, which corresponds to the end of the time window for the day 14 visit. A subject not satisfying case (i) or (ii), who takes nirmatrelvir/ritonavir or molnupiravir after initiating study treatment will be censored at the time that they first took this antiviral medication. Subjects not satisfying case (i), (ii), or (iii) will be censored at the last time that they have e-diary data recorded.
Outcome measures
| Measure |
Active
n=161 Participants
RD-X19 Active Device
Investigational device that uses 32 J/cm2 of electromagnetic energy to target the oropharynx.
|
Sham
n=166 Participants
RD-X19 Sham Device
Investigational device that uses safe electromagnetic energy to target the oropharynx but at energy levels with a lower inactivation potential against SARS-CoV2 in vitro.
|
|---|---|---|
|
Kaplan-Meier Estimates for Time to Sustained Resolution of COVID-19 Signs and Symptoms Without Subsequent Symptom Recurrence or Disease Progression (Until the End of the Study) Full Analysis Set (FAS)
25th percentile for time to sustained resolution
|
44.22 hours
Interval 26.628 to 64.44
|
62.49 hours
Interval 41.338 to 70.551
|
|
Kaplan-Meier Estimates for Time to Sustained Resolution of COVID-19 Signs and Symptoms Without Subsequent Symptom Recurrence or Disease Progression (Until the End of the Study) Full Analysis Set (FAS)
Median time to sustained resolution
|
100.36 hours
Interval 80.264 to 137.83
|
113.39 hours
Interval 89.617 to 140.69
|
|
Kaplan-Meier Estimates for Time to Sustained Resolution of COVID-19 Signs and Symptoms Without Subsequent Symptom Recurrence or Disease Progression (Until the End of the Study) Full Analysis Set (FAS)
75th percentile for time to sustained resolution
|
NA hours
Interval 209.97 to
Subjects did not meet the 75th percentile
|
261.35 hours
Interval 205.188 to
Subjects did not meet the 75th percentile
|
SECONDARY outcome
Timeframe: Baseline through Day 14Population: Full Analysis Set (FAS)
Number of subjects with two negative SARS-CoV-2 antigen tests (with a minimum time between tests of six hours) without subsequent virological rebound during the subject's remaining time on study. Subjects that are hospitalized will be censored at 360 hours, which corresponds to the end of the time window for the day 14 visit. A subject not satisfying case (i) or (ii), who takes nirmatrelvir/ritonavir or molnupiravir after initiating study treatment will be censored at the time that they first took this antiviral medication. Subjects not satisfying case (i), (ii), or (iii) will be censored at the last time that they have e-diary data recorded
Outcome measures
| Measure |
Active
n=161 Participants
RD-X19 Active Device
Investigational device that uses 32 J/cm2 of electromagnetic energy to target the oropharynx.
|
Sham
n=166 Participants
RD-X19 Sham Device
Investigational device that uses safe electromagnetic energy to target the oropharynx but at energy levels with a lower inactivation potential against SARS-CoV2 in vitro.
|
|---|---|---|
|
Number of Subjects With Two Negative SARS-CoV-2 Antigen Tests (With a Minimum Time Between Tests of Six Hours) Without Subsequent Virological Rebound During the Subject's Remaining Time on Study
|
146 Participants
|
157 Participants
|
SECONDARY outcome
Timeframe: Baseline through Day 14Population: Full Analysis Set (FAS)
time to first of two negative SARS-CoV-2 antigen tests (with a minimum time between tests of six hours) without subsequent virologic rebound (during the subject's remaining time on study) Full Analysis Set (FAS)
Outcome measures
| Measure |
Active
n=161 Participants
RD-X19 Active Device
Investigational device that uses 32 J/cm2 of electromagnetic energy to target the oropharynx.
|
Sham
n=166 Participants
RD-X19 Sham Device
Investigational device that uses safe electromagnetic energy to target the oropharynx but at energy levels with a lower inactivation potential against SARS-CoV2 in vitro.
|
|---|---|---|
|
Kaplan-Meier Estimates Time to First of Two Negative SARS-CoV-2 Antigen Tests
25th percentile for time to first of two negative SARS-CoV-2 tests
|
47.02 hours
Interval 41.241 to 60.457
|
52.89 hours
Interval 40.966 to 66.051
|
|
Kaplan-Meier Estimates Time to First of Two Negative SARS-CoV-2 Antigen Tests
Median time to first of two negative SARS-CoV-2 tests
|
74.58 hours
Interval 70.741 to 87.604
|
87.97 hours
Interval 75.473 to 96.581
|
|
Kaplan-Meier Estimates Time to First of Two Negative SARS-CoV-2 Antigen Tests
75th percentile for time to first of two negative SARS-CoV-2 tests
|
111.18 hours
Interval 100.228 to 121.916
|
133.42 hours
Interval 114.496 to 144.96
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Day 5, Day 8, and Day 14 or Early Termination VisitPopulation: Full Analysis Set (FAS)
The following are secondary qualitative measures (each taking the values yes, no) recorded at the post-baseline clinic visits for COVID-related assessment: In the past 24 hours, have you returned to your usual health (before your COVID-19 illness)? In the past 24 hours, have you returned to your usual activities (before your COVID-19 illness)?
Outcome measures
| Measure |
Active
n=161 Participants
RD-X19 Active Device
Investigational device that uses 32 J/cm2 of electromagnetic energy to target the oropharynx.
|
Sham
n=166 Participants
RD-X19 Sham Device
Investigational device that uses safe electromagnetic energy to target the oropharynx but at energy levels with a lower inactivation potential against SARS-CoV2 in vitro.
|
|---|---|---|
|
Secondary Qualitative Measures: COVID-19-related Assessment at Baseline, Day 5, 8 and 14/ET Visits (Full Analysis Set)
Returned to usual health in past 24 hours (Day 5 visit) · Yes
|
48 Participants
|
48 Participants
|
|
Secondary Qualitative Measures: COVID-19-related Assessment at Baseline, Day 5, 8 and 14/ET Visits (Full Analysis Set)
Returned to usual health in past 24 hours (Day 5 visit) · No
|
96 Participants
|
108 Participants
|
|
Secondary Qualitative Measures: COVID-19-related Assessment at Baseline, Day 5, 8 and 14/ET Visits (Full Analysis Set)
Returned to usual health in past 24 hours (Day 5 visit) · Missing
|
1 Participants
|
2 Participants
|
|
Secondary Qualitative Measures: COVID-19-related Assessment at Baseline, Day 5, 8 and 14/ET Visits (Full Analysis Set)
Returned to usual health in past 24 hours (Day 8 visit) · Yes
|
97 Participants
|
100 Participants
|
|
Secondary Qualitative Measures: COVID-19-related Assessment at Baseline, Day 5, 8 and 14/ET Visits (Full Analysis Set)
Returned to usual health in past 24 hours (Day 8 visit) · No
|
46 Participants
|
54 Participants
|
|
Secondary Qualitative Measures: COVID-19-related Assessment at Baseline, Day 5, 8 and 14/ET Visits (Full Analysis Set)
Returned to usual health in past 24 hours (Day 8 visit) · Missing
|
4 Participants
|
4 Participants
|
|
Secondary Qualitative Measures: COVID-19-related Assessment at Baseline, Day 5, 8 and 14/ET Visits (Full Analysis Set)
Returned to usual health in past 24 hours (Day 14/ET visit) · Yes
|
129 Participants
|
132 Participants
|
|
Secondary Qualitative Measures: COVID-19-related Assessment at Baseline, Day 5, 8 and 14/ET Visits (Full Analysis Set)
Returned to usual health in past 24 hours (Day 14/ET visit) · No
|
23 Participants
|
22 Participants
|
|
Secondary Qualitative Measures: COVID-19-related Assessment at Baseline, Day 5, 8 and 14/ET Visits (Full Analysis Set)
Returned to usual health in past 24 hours (Day 14/ET visit) · Missing
|
2 Participants
|
4 Participants
|
|
Secondary Qualitative Measures: COVID-19-related Assessment at Baseline, Day 5, 8 and 14/ET Visits (Full Analysis Set)
Returned to usual activities in past 24 hours (Day 5 visit) · Yes
|
67 Participants
|
71 Participants
|
|
Secondary Qualitative Measures: COVID-19-related Assessment at Baseline, Day 5, 8 and 14/ET Visits (Full Analysis Set)
Returned to usual activities in past 24 hours (Day 5 visit) · No
|
77 Participants
|
85 Participants
|
|
Secondary Qualitative Measures: COVID-19-related Assessment at Baseline, Day 5, 8 and 14/ET Visits (Full Analysis Set)
Returned to usual activities in past 24 hours (Day 5 visit) · Missing
|
1 Participants
|
2 Participants
|
|
Secondary Qualitative Measures: COVID-19-related Assessment at Baseline, Day 5, 8 and 14/ET Visits (Full Analysis Set)
Returned to usual activities in past 24 hours (Day 8 visit) · Yes
|
115 Participants
|
115 Participants
|
|
Secondary Qualitative Measures: COVID-19-related Assessment at Baseline, Day 5, 8 and 14/ET Visits (Full Analysis Set)
Returned to usual activities in past 24 hours (Day 8 visit) · No
|
28 Participants
|
38 Participants
|
|
Secondary Qualitative Measures: COVID-19-related Assessment at Baseline, Day 5, 8 and 14/ET Visits (Full Analysis Set)
Returned to usual activities in past 24 hours (Day 8 visit) · Missing
|
4 Participants
|
5 Participants
|
|
Secondary Qualitative Measures: COVID-19-related Assessment at Baseline, Day 5, 8 and 14/ET Visits (Full Analysis Set)
Returned to usual activities in past 24 hours (Day 14/ET visit) · Yes
|
137 Participants
|
138 Participants
|
|
Secondary Qualitative Measures: COVID-19-related Assessment at Baseline, Day 5, 8 and 14/ET Visits (Full Analysis Set)
Returned to usual activities in past 24 hours (Day 14/ET visit) · No
|
15 Participants
|
16 Participants
|
|
Secondary Qualitative Measures: COVID-19-related Assessment at Baseline, Day 5, 8 and 14/ET Visits (Full Analysis Set)
Returned to usual activities in past 24 hours (Day 14/ET visit) · Missing
|
2 Participants
|
4 Participants
|
Adverse Events
Active
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
Sham
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Active
n=158 participants at risk
RD-X19 Active Device
Investigational device that uses 32 J/cm2 of electromagnetic energy to target the oropharynx.
|
Sham
n=162 participants at risk
RD-X19 Sham Device
Investigational device that uses safe electromagnetic energy to target the oropharynx but at energy levels with a lower inactivation potential against SARS-CoV2 in vitro.
|
|---|---|---|
|
Nervous system disorders
Headache
|
2.5%
4/158 • 14 days
Solicited and Unsolicited Treatment Emergent Adverse Events (TEAEs) will be recorded by clinical trial staff for the entire duration of the study, beginning after device administration and through day 14 or an early termination visit. No Adverse Events (AEs) that are not TEAEs are expected in this study since the time between enrollment and the first treatment is very brief. The safety population will consist of all randomized subjects who received any study treatment.
|
0.62%
1/162 • 14 days
Solicited and Unsolicited Treatment Emergent Adverse Events (TEAEs) will be recorded by clinical trial staff for the entire duration of the study, beginning after device administration and through day 14 or an early termination visit. No Adverse Events (AEs) that are not TEAEs are expected in this study since the time between enrollment and the first treatment is very brief. The safety population will consist of all randomized subjects who received any study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
1.9%
3/158 • 14 days
Solicited and Unsolicited Treatment Emergent Adverse Events (TEAEs) will be recorded by clinical trial staff for the entire duration of the study, beginning after device administration and through day 14 or an early termination visit. No Adverse Events (AEs) that are not TEAEs are expected in this study since the time between enrollment and the first treatment is very brief. The safety population will consist of all randomized subjects who received any study treatment.
|
1.2%
2/162 • 14 days
Solicited and Unsolicited Treatment Emergent Adverse Events (TEAEs) will be recorded by clinical trial staff for the entire duration of the study, beginning after device administration and through day 14 or an early termination visit. No Adverse Events (AEs) that are not TEAEs are expected in this study since the time between enrollment and the first treatment is very brief. The safety population will consist of all randomized subjects who received any study treatment.
|
|
Gastrointestinal disorders
Dry Mouth
|
1.9%
3/158 • 14 days
Solicited and Unsolicited Treatment Emergent Adverse Events (TEAEs) will be recorded by clinical trial staff for the entire duration of the study, beginning after device administration and through day 14 or an early termination visit. No Adverse Events (AEs) that are not TEAEs are expected in this study since the time between enrollment and the first treatment is very brief. The safety population will consist of all randomized subjects who received any study treatment.
|
0.62%
1/162 • 14 days
Solicited and Unsolicited Treatment Emergent Adverse Events (TEAEs) will be recorded by clinical trial staff for the entire duration of the study, beginning after device administration and through day 14 or an early termination visit. No Adverse Events (AEs) that are not TEAEs are expected in this study since the time between enrollment and the first treatment is very brief. The safety population will consist of all randomized subjects who received any study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.9%
3/158 • 14 days
Solicited and Unsolicited Treatment Emergent Adverse Events (TEAEs) will be recorded by clinical trial staff for the entire duration of the study, beginning after device administration and through day 14 or an early termination visit. No Adverse Events (AEs) that are not TEAEs are expected in this study since the time between enrollment and the first treatment is very brief. The safety population will consist of all randomized subjects who received any study treatment.
|
0.62%
1/162 • 14 days
Solicited and Unsolicited Treatment Emergent Adverse Events (TEAEs) will be recorded by clinical trial staff for the entire duration of the study, beginning after device administration and through day 14 or an early termination visit. No Adverse Events (AEs) that are not TEAEs are expected in this study since the time between enrollment and the first treatment is very brief. The safety population will consist of all randomized subjects who received any study treatment.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
1.9%
3/158 • 14 days
Solicited and Unsolicited Treatment Emergent Adverse Events (TEAEs) will be recorded by clinical trial staff for the entire duration of the study, beginning after device administration and through day 14 or an early termination visit. No Adverse Events (AEs) that are not TEAEs are expected in this study since the time between enrollment and the first treatment is very brief. The safety population will consist of all randomized subjects who received any study treatment.
|
0.62%
1/162 • 14 days
Solicited and Unsolicited Treatment Emergent Adverse Events (TEAEs) will be recorded by clinical trial staff for the entire duration of the study, beginning after device administration and through day 14 or an early termination visit. No Adverse Events (AEs) that are not TEAEs are expected in this study since the time between enrollment and the first treatment is very brief. The safety population will consist of all randomized subjects who received any study treatment.
|
|
Gastrointestinal disorders
Nausea
|
0.63%
1/158 • 14 days
Solicited and Unsolicited Treatment Emergent Adverse Events (TEAEs) will be recorded by clinical trial staff for the entire duration of the study, beginning after device administration and through day 14 or an early termination visit. No Adverse Events (AEs) that are not TEAEs are expected in this study since the time between enrollment and the first treatment is very brief. The safety population will consist of all randomized subjects who received any study treatment.
|
1.9%
3/162 • 14 days
Solicited and Unsolicited Treatment Emergent Adverse Events (TEAEs) will be recorded by clinical trial staff for the entire duration of the study, beginning after device administration and through day 14 or an early termination visit. No Adverse Events (AEs) that are not TEAEs are expected in this study since the time between enrollment and the first treatment is very brief. The safety population will consist of all randomized subjects who received any study treatment.
|
|
Infections and infestations
Pharyngitis
|
0.63%
1/158 • 14 days
Solicited and Unsolicited Treatment Emergent Adverse Events (TEAEs) will be recorded by clinical trial staff for the entire duration of the study, beginning after device administration and through day 14 or an early termination visit. No Adverse Events (AEs) that are not TEAEs are expected in this study since the time between enrollment and the first treatment is very brief. The safety population will consist of all randomized subjects who received any study treatment.
|
1.9%
3/162 • 14 days
Solicited and Unsolicited Treatment Emergent Adverse Events (TEAEs) will be recorded by clinical trial staff for the entire duration of the study, beginning after device administration and through day 14 or an early termination visit. No Adverse Events (AEs) that are not TEAEs are expected in this study since the time between enrollment and the first treatment is very brief. The safety population will consist of all randomized subjects who received any study treatment.
|
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 may 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