Trial Outcomes & Findings for Evaluation of the RD-X19 Treatment Device in Individuals With Mild to Moderate COVID-19 (NCT NCT04966013)
NCT ID: NCT04966013
Last Updated: 2024-09-19
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 reporting a persistent fever (100.5 degrees for 36 hours or more) and/or SpO2 levels \<96% with any shortness of breath are considered not to have met the success criterion on that day even if all other symptoms are reported as none (0) or mild (1).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
216 participants
Primary outcome timeframe
Baseline thru Day 14
Results posted on
2024-09-19
Participant Flow
Participant milestones
| Measure |
RD-X19 Device, Dose A
Investigational device that delivers 24 J/cm2
|
RD-X19 Device, Dose B
Investigational device that delivers 32 J/cm2
|
Sham Device
Investigational device that uses safe electromagnetic energy to target the oropharynx but at energy levels with a lower inactivation potential against SARS-CoV-2 in vitro.
|
|---|---|---|---|
|
Overall Study
STARTED
|
28
|
117
|
71
|
|
Overall Study
COMPLETED
|
26
|
114
|
69
|
|
Overall Study
NOT COMPLETED
|
2
|
3
|
2
|
Reasons for withdrawal
| Measure |
RD-X19 Device, Dose A
Investigational device that delivers 24 J/cm2
|
RD-X19 Device, Dose B
Investigational device that delivers 32 J/cm2
|
Sham Device
Investigational device that uses safe electromagnetic energy to target the oropharynx but at energy levels with a lower inactivation potential against SARS-CoV-2 in vitro.
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
2
|
1
|
|
Overall Study
Adverse Event
|
2
|
1
|
1
|
Baseline Characteristics
Evaluation of the RD-X19 Treatment Device in Individuals With Mild to Moderate COVID-19
Baseline characteristics by cohort
| Measure |
RD-X19 Device, Dose A
n=28 Participants
RD-X19. Investigational device that uses safe electromagnetic energy to target the oropharynx.
RD-X19: Investigational device that uses safe electromagnetic energy to target the oropharynx.
|
RD-X19 Device, Dose B
n=117 Participants
RD-X19. Investigational device that uses safe electromagnetic energy to target the oropharynx.
RD-X19: Investigational device that uses safe electromagnetic energy to target the oropharynx.
|
Sham Device
n=71 Participants
Investigational device that uses safe electromagnetic energy to target the oropharynx but at energy levels with a lower inactivation potential against SARS-CoV-2 in vitro.
Sham: Investigational device that uses safe electromagnetic energy to target the oropharynx but at energy levels with a lower inactivation potential against SARS-CoV-2 in vitro..
|
Total
n=216 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
Age in years
|
38.3 years
STANDARD_DEVIATION 11.76 • n=5 Participants
|
38.3 years
STANDARD_DEVIATION 12.57 • n=7 Participants
|
38.6 years
STANDARD_DEVIATION 13.39 • n=5 Participants
|
38.4 years
STANDARD_DEVIATION 12.69 • n=4 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
63 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
111 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
54 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
105 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
21 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
67 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=5 Participants
|
93 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
149 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
27 Participants
n=5 Participants
|
94 Participants
n=7 Participants
|
63 Participants
n=5 Participants
|
184 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
28 participants
n=5 Participants
|
117 participants
n=7 Participants
|
71 participants
n=5 Participants
|
216 participants
n=4 Participants
|
|
COVID-19 Composite Severity Score
|
1.496 units on a scale
STANDARD_DEVIATION 0.4481 • n=5 Participants
|
1.480 units on a scale
STANDARD_DEVIATION 0.4563 • n=7 Participants
|
1.438 units on a scale
STANDARD_DEVIATION 0.4914 • n=5 Participants
|
1.468 units on a scale
STANDARD_DEVIATION 0.4654 • n=4 Participants
|
|
Baseline disease Severity
Mild COVID
|
26 Participants
n=5 Participants
|
64 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
135 Participants
n=4 Participants
|
|
Baseline disease Severity
Moderate COVID
|
2 Participants
n=5 Participants
|
53 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
81 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline thru Day 14Population: Cohort B, subjects with mild or moderate disease at baseline. Primary analysis was not performed on Cohort A
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 reporting a persistent fever (100.5 degrees for 36 hours or more) and/or SpO2 levels \<96% with any shortness of breath are considered not to have met the success criterion on that day even if all other symptoms are reported as none (0) or mild (1).
Outcome measures
| Measure |
RD-X19 Device, Dose B
n=117 Participants
Investigational device that delivers 32 J/cm2
|
RD-X19 Device, Cohort A
n=28 Participants
Investigational Device that delivers 16 J/cm2
|
Sham Device
n=57 Participants
Investigational device that uses safe electromagnetic energy to target the oropharynx but at energy levels with a lower inactivation potential against SARS-CoV-2 in vitro.
|
|---|---|---|---|
|
Time to Sustained Resolution of COVID-19 Signs and Symptoms in All Subjects (With Mild or Moderate Disease at Baseline).
Median of Time to Sustained Resolution
|
113.5 Time in hours
Interval 99.3 to 142.5
|
172.1 Time in hours
Interval 115.5 to 223.5
|
115.1 Time in hours
Interval 81.9 to 166.3
|
|
Time to Sustained Resolution of COVID-19 Signs and Symptoms in All Subjects (With Mild or Moderate Disease at Baseline).
25th Percentile of Time to Sustained Resolution
|
63.8 Time in hours
Interval 52.7 to 82.7
|
91.6 Time in hours
Interval 66.0 to 160.7
|
55.4 Time in hours
Interval 42.7 to 81.9
|
|
Time to Sustained Resolution of COVID-19 Signs and Symptoms in All Subjects (With Mild or Moderate Disease at Baseline).
75th Percentile of Time to Sustained Resolution
|
190.6 Time in hours
Interval 164.5 to 246.3
|
266.3 Time in hours
Interval 192.1 to 384.0
|
196.6 Time in hours
Interval 166.3 to 294.9
|
PRIMARY outcome
Timeframe: Baseline thru Day 14Population: Cohort B, subject of subjects with mild disease at baseline
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 reporting a persistent fever (100.5 degrees for 36 hours or more) and/or SpO2 levels \<96% with any shortness of breath are considered not to have met the success criterion on that day even if all other symptoms are reported as none (0) or mild (1).
Outcome measures
| Measure |
RD-X19 Device, Dose B
n=64 Participants
Investigational device that delivers 32 J/cm2
|
RD-X19 Device, Cohort A
n=34 Participants
Investigational Device that delivers 16 J/cm2
|
Sham Device
n=26 Participants
Investigational device that uses safe electromagnetic energy to target the oropharynx but at energy levels with a lower inactivation potential against SARS-CoV-2 in vitro.
|
|---|---|---|---|
|
Sustained Resolution of COVID-19 Signs and Symptoms in Subjects With Mild Disease at Baseline.
Median Time of Sustained Resolution
|
99.3 Time in hours
Interval 72.2 to 119.3
|
119.5 Time in hours
Interval 78.0 to 185.6
|
172.1 Time in hours
Interval 101.8 to 223.5
|
|
Sustained Resolution of COVID-19 Signs and Symptoms in Subjects With Mild Disease at Baseline.
25th Percentile of Time to Sustained Resolution
|
54.8 Time in hours
Interval 45.1 to 72.2
|
47.9 Time in hours
Interval 42.7 to 93.0
|
87.9 Time in hours
Interval 66.0 to 160.7
|
|
Sustained Resolution of COVID-19 Signs and Symptoms in Subjects With Mild Disease at Baseline.
75th Percentile of Time to Sustained Resolution
|
164.8 Time in hours
Interval 120.3 to 222.3
|
196.6 Time in hours
Interval 144.0 to 322.0
|
254.7 Time in hours
Interval 192.1 to 384.0
|
SECONDARY outcome
Timeframe: Baseline thru Day 14Numbers and percentages of study subjects who require medical attention or intervention attributed to COVID-19;
Outcome measures
| Measure |
RD-X19 Device, Dose B
n=28 Participants
Investigational device that delivers 32 J/cm2
|
RD-X19 Device, Cohort A
n=117 Participants
Investigational Device that delivers 16 J/cm2
|
Sham Device
n=71 Participants
Investigational device that uses safe electromagnetic energy to target the oropharynx but at energy levels with a lower inactivation potential against SARS-CoV-2 in vitro.
|
|---|---|---|---|
|
Medically Attended Visits
|
5 Participants
|
5 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Baseline thru Day 14Numbers and percentages of study subjects who progress to severe disease with respiratory rate \>30/minute and/or O2 saturation \</=93% on room air or FiO2 ≥300% with any respiratory distress.
Outcome measures
| Measure |
RD-X19 Device, Dose B
n=28 Participants
Investigational device that delivers 32 J/cm2
|
RD-X19 Device, Cohort A
n=117 Participants
Investigational Device that delivers 16 J/cm2
|
Sham Device
n=71 Participants
Investigational device that uses safe electromagnetic energy to target the oropharynx but at energy levels with a lower inactivation potential against SARS-CoV-2 in vitro.
|
|---|---|---|---|
|
Severe Disease Progression
|
3 Participants
|
2 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline thru Day 14Numbers and percentages of study subjects who require hospitalization for severe COVID-19.
Outcome measures
| Measure |
RD-X19 Device, Dose B
n=28 Participants
Investigational device that delivers 32 J/cm2
|
RD-X19 Device, Cohort A
n=117 Participants
Investigational Device that delivers 16 J/cm2
|
Sham Device
n=71 Participants
Investigational device that uses safe electromagnetic energy to target the oropharynx but at energy levels with a lower inactivation potential against SARS-CoV-2 in vitro.
|
|---|---|---|---|
|
Hospitalizations
|
4 Participants
|
3 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Day 3 thru Day 14Number and percentage of study subjects who experience progression of COVID-19 as defined by an increase of the composite COVID-19 severity score greater than baseline at any point in the study on or after day 3.
Outcome measures
| Measure |
RD-X19 Device, Dose B
n=28 Participants
Investigational device that delivers 32 J/cm2
|
RD-X19 Device, Cohort A
n=117 Participants
Investigational Device that delivers 16 J/cm2
|
Sham Device
n=71 Participants
Investigational device that uses safe electromagnetic energy to target the oropharynx but at energy levels with a lower inactivation potential against SARS-CoV-2 in vitro.
|
|---|---|---|---|
|
Worsening of Disease
|
5 Participants
|
10 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: Days 8 and 14Population: Visit 4/Day8
Numbers and percentages of study subjects on day 8 and day 14 who answer yes to the following patient-reported global impression assessments, a) return to usual health and b) return to usual activities. 1. In the past 24 hours, have you returned to your usual health (before your COVID-19 illness)? Yes or No 2. In the past 24 hours, have you returned to your usual activities (before your COVID-19 illness)? Yes or No Note: subjects with missing Data at Day 8 or Day 14 were not included in total subjects analyzed
Outcome measures
| Measure |
RD-X19 Device, Dose B
n=28 Participants
Investigational device that delivers 32 J/cm2
|
RD-X19 Device, Cohort A
n=117 Participants
Investigational Device that delivers 16 J/cm2
|
Sham Device
n=71 Participants
Investigational device that uses safe electromagnetic energy to target the oropharynx but at energy levels with a lower inactivation potential against SARS-CoV-2 in vitro.
|
|---|---|---|---|
|
Return to Pre-COVID Health
Subjects who returned to usual health on Day 8
|
10 Participants
|
54 Participants
|
27 Participants
|
|
Return to Pre-COVID Health
Subjects who returned to usual activities on Day 8
|
9 Participants
|
74 Participants
|
41 Participants
|
|
Return to Pre-COVID Health
Subjects who returned to usual health on Day 14
|
17 Participants
|
84 Participants
|
49 Participants
|
|
Return to Pre-COVID Health
Subjects who returned to usual activities on Day 14
|
16 Participants
|
96 Participants
|
56 Participants
|
SECONDARY outcome
Timeframe: Days 3, 5, 8 and 14Population: Subjects with Mild and Moderate Disease at Baseline
Mean change in nasopharyngeal viral load from baseline on days 3, 5, 8, and 14.
Outcome measures
| Measure |
RD-X19 Device, Dose B
n=22 Participants
Investigational device that delivers 32 J/cm2
|
RD-X19 Device, Cohort A
n=114 Participants
Investigational Device that delivers 16 J/cm2
|
Sham Device
n=67 Participants
Investigational device that uses safe electromagnetic energy to target the oropharynx but at energy levels with a lower inactivation potential against SARS-CoV-2 in vitro.
|
|---|---|---|---|
|
Mean Change in Nasopharyngeal Viral Load
Day 5
|
-2.218 Log10 copies/mL
Standard Deviation 0.9273
|
-2.649 Log10 copies/mL
Standard Deviation 1.6975
|
-2.107 Log10 copies/mL
Standard Deviation 1.9003
|
|
Mean Change in Nasopharyngeal Viral Load
Day 8
|
-3.663 Log10 copies/mL
Standard Deviation 1.8057
|
-4.132 Log10 copies/mL
Standard Deviation 1.9791
|
-3.744 Log10 copies/mL
Standard Deviation 1.8545
|
|
Mean Change in Nasopharyngeal Viral Load
Day 3
|
-0.849 Log10 copies/mL
Standard Deviation 0.8828
|
-1.269 Log10 copies/mL
Standard Deviation 1.0666
|
-0.928 Log10 copies/mL
Standard Deviation 1.7048
|
|
Mean Change in Nasopharyngeal Viral Load
Day 14
|
-4.827 Log10 copies/mL
Standard Deviation 1.6769
|
-5.584 Log10 copies/mL
Standard Deviation 1.5876
|
-5.084 Log10 copies/mL
Standard Deviation 2.1024
|
SECONDARY outcome
Timeframe: Days 3, 5, 8 and 14Proportion of subjects demonstrating clearance of viral infection on Days 3, 5, 8 and 14.
Outcome measures
| Measure |
RD-X19 Device, Dose B
n=22 Participants
Investigational device that delivers 32 J/cm2
|
RD-X19 Device, Cohort A
n=114 Participants
Investigational Device that delivers 16 J/cm2
|
Sham Device
n=67 Participants
Investigational device that uses safe electromagnetic energy to target the oropharynx but at energy levels with a lower inactivation potential against SARS-CoV-2 in vitro.
|
|---|---|---|---|
|
Proportion of Subjects Demonstrating Clearance of Viral Infection
Day 3
|
0 Participants
|
2 Participants
|
4 Participants
|
|
Proportion of Subjects Demonstrating Clearance of Viral Infection
Day 5
|
0 Participants
|
15 Participants
|
6 Participants
|
|
Proportion of Subjects Demonstrating Clearance of Viral Infection
Day 8
|
1 Participants
|
34 Participants
|
19 Participants
|
|
Proportion of Subjects Demonstrating Clearance of Viral Infection
Day 14
|
2 Participants
|
68 Participants
|
34 Participants
|
SECONDARY outcome
Timeframe: Baseline thru Day 8Population: N (%) subjects achieving success on Composite Resolution
Proportion of study subjects who achieve Day 8 Composite Resolution.
Outcome measures
| Measure |
RD-X19 Device, Dose B
n=25 Participants
Investigational device that delivers 32 J/cm2
|
RD-X19 Device, Cohort A
n=113 Participants
Investigational Device that delivers 16 J/cm2
|
Sham Device
n=70 Participants
Investigational device that uses safe electromagnetic energy to target the oropharynx but at energy levels with a lower inactivation potential against SARS-CoV-2 in vitro.
|
|---|---|---|---|
|
Day 8 Composite Resolution
|
14 Participants
|
81 Participants
|
48 Participants
|
SECONDARY outcome
Timeframe: Baseline thru Day 14Number and percentage of study subjects who require endotracheal ventilation or ECMO with or without the use of solumedrol.
Outcome measures
| Measure |
RD-X19 Device, Dose B
n=28 Participants
Investigational device that delivers 32 J/cm2
|
RD-X19 Device, Cohort A
n=117 Participants
Investigational Device that delivers 16 J/cm2
|
Sham Device
n=71 Participants
Investigational device that uses safe electromagnetic energy to target the oropharynx but at energy levels with a lower inactivation potential against SARS-CoV-2 in vitro.
|
|---|---|---|---|
|
Endotracheal Ventilation or ECMO
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline thru Day 14Number and percentage of study subjects who die.
Outcome measures
| Measure |
RD-X19 Device, Dose B
n=28 Participants
Investigational device that delivers 32 J/cm2
|
RD-X19 Device, Cohort A
n=117 Participants
Investigational Device that delivers 16 J/cm2
|
Sham Device
n=71 Participants
Investigational device that uses safe electromagnetic energy to target the oropharynx but at energy levels with a lower inactivation potential against SARS-CoV-2 in vitro.
|
|---|---|---|---|
|
Death
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
RD-X19 Device, Dose A
Serious events: 4 serious events
Other events: 19 other events
Deaths: 0 deaths
RD-X19 Device, Dose B
Serious events: 3 serious events
Other events: 55 other events
Deaths: 0 deaths
Sham Device
Serious events: 2 serious events
Other events: 39 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
RD-X19 Device, Dose A
n=28 participants at risk
RD-X19. Investigational device that uses safe electromagnetic energy to target the oropharynx.
RD-X19: Investigational device that uses safe electromagnetic energy to target the oropharynx.
|
RD-X19 Device, Dose B
n=117 participants at risk
RD-X19. Investigational device that uses safe electromagnetic energy to target the oropharynx.
RD-X19: Investigational device that uses safe electromagnetic energy to target the oropharynx.
|
Sham Device
n=71 participants at risk
Investigational device that uses safe electromagnetic energy to target the oropharynx but at energy levels with a lower inactivation potential against SARS-CoV-2 in vitro.
Sham: Investigational device that uses safe electromagnetic energy to target the oropharynx but at energy levels with a lower inactivation potential against SARS-CoV-2 in vitro..
|
|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Failure
|
10.7%
3/28 • Number of events 3 • Through day 14 (±2 days)
|
2.6%
3/117 • Number of events 3 • Through day 14 (±2 days)
|
0.00%
0/71 • Through day 14 (±2 days)
|
|
Infections and infestations
Covid-19 Pneumonia
|
14.3%
4/28 • Number of events 4 • Through day 14 (±2 days)
|
1.7%
2/117 • Number of events 2 • Through day 14 (±2 days)
|
2.8%
2/71 • Number of events 2 • Through day 14 (±2 days)
|
Other adverse events
| Measure |
RD-X19 Device, Dose A
n=28 participants at risk
RD-X19. Investigational device that uses safe electromagnetic energy to target the oropharynx.
RD-X19: Investigational device that uses safe electromagnetic energy to target the oropharynx.
|
RD-X19 Device, Dose B
n=117 participants at risk
RD-X19. Investigational device that uses safe electromagnetic energy to target the oropharynx.
RD-X19: Investigational device that uses safe electromagnetic energy to target the oropharynx.
|
Sham Device
n=71 participants at risk
Investigational device that uses safe electromagnetic energy to target the oropharynx but at energy levels with a lower inactivation potential against SARS-CoV-2 in vitro.
Sham: Investigational device that uses safe electromagnetic energy to target the oropharynx but at energy levels with a lower inactivation potential against SARS-CoV-2 in vitro..
|
|---|---|---|---|
|
General disorders
Administrative Site Pain
|
0.00%
0/28 • Through day 14 (±2 days)
|
3.4%
4/117 • Through day 14 (±2 days)
|
1.4%
1/71 • Through day 14 (±2 days)
|
|
Gastrointestinal disorders
Nausea
|
10.7%
3/28 • Through day 14 (±2 days)
|
11.1%
13/117 • Through day 14 (±2 days)
|
15.5%
11/71 • Through day 14 (±2 days)
|
|
Gastrointestinal disorders
Toothache
|
3.6%
1/28 • Through day 14 (±2 days)
|
0.00%
0/117 • Through day 14 (±2 days)
|
1.4%
1/71 • Through day 14 (±2 days)
|
|
General disorders
Chest Pain
|
3.6%
1/28 • Through day 14 (±2 days)
|
0.00%
0/117 • Through day 14 (±2 days)
|
0.00%
0/71 • Through day 14 (±2 days)
|
|
General disorders
Chills
|
7.1%
2/28 • Through day 14 (±2 days)
|
5.1%
6/117 • Through day 14 (±2 days)
|
9.9%
7/71 • Through day 14 (±2 days)
|
|
General disorders
Fatigue
|
3.6%
1/28 • Through day 14 (±2 days)
|
9.4%
11/117 • Through day 14 (±2 days)
|
8.5%
6/71 • Through day 14 (±2 days)
|
|
General disorders
Malaise
|
3.6%
1/28 • Through day 14 (±2 days)
|
0.00%
0/117 • Through day 14 (±2 days)
|
0.00%
0/71 • Through day 14 (±2 days)
|
|
Infections and infestations
Covid-19 Pneumonia
|
14.3%
4/28 • Through day 14 (±2 days)
|
4.3%
5/117 • Through day 14 (±2 days)
|
2.8%
2/71 • Through day 14 (±2 days)
|
|
Infections and infestations
Sepsis
|
3.6%
1/28 • Through day 14 (±2 days)
|
0.00%
0/117 • Through day 14 (±2 days)
|
0.00%
0/71 • Through day 14 (±2 days)
|
|
Investigations
Neutrophil/Lymphocyte Ratio Increased
|
3.6%
1/28 • Through day 14 (±2 days)
|
6.0%
7/117 • Through day 14 (±2 days)
|
5.6%
4/71 • Through day 14 (±2 days)
|
|
Investigations
Red Cell Distribution Width Increased
|
7.1%
2/28 • Through day 14 (±2 days)
|
0.00%
0/117 • Through day 14 (±2 days)
|
0.00%
0/71 • Through day 14 (±2 days)
|
|
Metabolism and nutrition disorders
Dehydration
|
3.6%
1/28 • Through day 14 (±2 days)
|
0.85%
1/117 • Through day 14 (±2 days)
|
0.00%
0/71 • Through day 14 (±2 days)
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
3.6%
1/28 • Through day 14 (±2 days)
|
0.00%
0/117 • Through day 14 (±2 days)
|
0.00%
0/71 • Through day 14 (±2 days)
|
|
Metabolism and nutrition disorders
Hypokalemia
|
3.6%
1/28 • Through day 14 (±2 days)
|
0.00%
0/117 • Through day 14 (±2 days)
|
0.00%
0/71 • Through day 14 (±2 days)
|
|
Metabolism and nutrition disorders
Hyponatremia
|
3.6%
1/28 • Through day 14 (±2 days)
|
0.00%
0/117 • Through day 14 (±2 days)
|
0.00%
0/71 • Through day 14 (±2 days)
|
|
Musculoskeletal and connective tissue disorders
Jaw Clicking
|
3.6%
1/28 • Through day 14 (±2 days)
|
0.00%
0/117 • Through day 14 (±2 days)
|
0.00%
0/71 • Through day 14 (±2 days)
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasm
|
3.6%
1/28 • Through day 14 (±2 days)
|
0.00%
0/117 • Through day 14 (±2 days)
|
0.00%
0/71 • Through day 14 (±2 days)
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
7.1%
2/28 • Through day 14 (±2 days)
|
6.0%
7/117 • Through day 14 (±2 days)
|
1.4%
1/71 • Through day 14 (±2 days)
|
|
Musculoskeletal and connective tissue disorders
Pain in Jaw
|
3.6%
1/28 • Through day 14 (±2 days)
|
0.00%
0/117 • Through day 14 (±2 days)
|
0.00%
0/71 • Through day 14 (±2 days)
|
|
Nervous system disorders
Headache
|
7.1%
2/28 • Through day 14 (±2 days)
|
7.7%
9/117 • Through day 14 (±2 days)
|
9.9%
7/71 • Through day 14 (±2 days)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
25.0%
7/28 • Through day 14 (±2 days)
|
10.3%
12/117 • Through day 14 (±2 days)
|
14.1%
10/71 • Through day 14 (±2 days)
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
14.3%
4/28 • Through day 14 (±2 days)
|
8.5%
10/117 • Through day 14 (±2 days)
|
7.0%
5/71 • Through day 14 (±2 days)
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
7.1%
2/28 • Through day 14 (±2 days)
|
11.1%
13/117 • Through day 14 (±2 days)
|
2.8%
2/71 • Through day 14 (±2 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 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