Trial Outcomes & Findings for Study Assessing Vagus Nerve Stimulation in CoViD-19 Respiratory Symptoms (NCT NCT04382391)
NCT ID: NCT04382391
Last Updated: 2024-05-01
Results Overview
compare clinical events between the control group and active group for patients admitted to the hospital for CoViD-19.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
21 participants
Primary outcome timeframe
From baseline to 90 days post-discharge
Results posted on
2024-05-01
Participant Flow
21 patients enrolled into the study: 11 control patients, 10 experimental (nVNS arm); First patient consented on 15May2020 and final patient consented on 09Feb2021. Original enrollment target was 60 patients, however, enrollment slowed as number of inpatient Covid cases decreased, thus creating it difficult to enroll. New and approved treatment options became available for this population, thus it was determined to close enrollment in this trial prior to achieving 60 patients.
Participant milestones
| Measure |
gammaCore Sapphire® (nVNS) Plus Standard of Care
Subjects will be administered study treatment with the nVNS device 3 times per day (prophylaxis) and also as needed for acute respiratory symptoms.
gammaCore® Sapphire (non-invasive vagus nerve stimulator): Administer gammaCore® Sapphire daily, prophylactically, for three treatments (morning, mid-day and night, one hour before bed), each treatment consisting of two 2-minute doses/stimulations, one on each side of the neck. This would be a total of 6 treatments (2 doses x 3 times per day) of stimulation.
For acute respiratory distress or shortness of breath (SOB), administer one treatment consisting of two 2-minute stimulations, on the neck. If respiratory distress or shortness of breath persists 20 minutes after the start of the first treatment, administer a second treatment.
Standard of care therapies: Will receive standard of care therapies for the treatment of CoViD-19 infection and symptoms
|
Standard of Care Alone
Will receive standard of care therapies to treat CoViD-19 infection and symptoms
Standard of care therapies: Will receive standard of care therapies for the treatment of CoViD-19 infection and symptoms
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
11
|
|
Overall Study
COMPLETED
|
10
|
11
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
gammaCore Sapphire® (nVNS) Plus Standard of Care
n=10 Participants
Subjects will be administered study treatment with the nVNS device 3 times per day (prophylaxis) and also as needed for acute respiratory symptoms.
gammaCore® Sapphire (non-invasive vagus nerve stimulator): Administer gammaCore® Sapphire daily, prophylactically, for three treatments (morning, mid-day and night, one hour before bed), each treatment consisting of two 2-minute doses/stimulations, one on each side of the neck. This would be a total of 6 treatments (2 doses x 3 times per day) of stimulation.
For acute respiratory distress or shortness of breath (SOB), administer one treatment consisting of two 2-minute stimulations, on the neck. If respiratory distress or shortness of breath persists 20 minutes after the start of the first treatment, administer a second treatment.
Standard of care therapies: Will receive standard of care therapies for the treatment of CoViD-19 infection and symptoms
|
Standard of Care Alone
n=11 Participants
Will receive standard of care therapies to treat CoViD-19 infection and symptoms
Standard of care therapies: Will receive standard of care therapies for the treatment of CoViD-19 infection and symptoms
|
Total
n=21 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=10 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=10 Participants
|
7 Participants
n=11 Participants
|
13 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=10 Participants
|
4 Participants
n=11 Participants
|
8 Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=10 Participants
|
2 Participants
n=11 Participants
|
6 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=10 Participants
|
9 Participants
n=11 Participants
|
15 Participants
n=21 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
10 participants
n=10 Participants
|
11 participants
n=11 Participants
|
21 participants
n=21 Participants
|
|
Requiring Intubation
|
0 Participants
n=10 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=21 Participants
|
|
mean oxygen saturation (baseline)
|
91.6 Percent saturation of peripheral oxygen
n=10 Participants
|
92.8 Percent saturation of peripheral oxygen
n=11 Participants
|
92.2 Percent saturation of peripheral oxygen
n=21 Participants
|
PRIMARY outcome
Timeframe: From baseline to 90 days post-dischargecompare clinical events between the control group and active group for patients admitted to the hospital for CoViD-19.
Outcome measures
| Measure |
gammaCore Sapphire® (nVNS) Plus Standard of Care
n=10 Participants
Subjects will be administered study treatment with the nVNS device 3 times per day (prophylaxis) and also as needed for acute respiratory symptoms.
gammaCore® Sapphire (non-invasive vagus nerve stimulator): Administer gammaCore® Sapphire daily, prophylactically, for three treatments (morning, mid-day and night, one hour before bed), each treatment consisting of two 2-minute doses/stimulations, one on each side of the neck. This would be a total of 6 treatments (2 doses x 3 times per day) of stimulation.
For acute respiratory distress or shortness of breath (SOB), administer one treatment consisting of two 2-minute stimulations, on the neck. If respiratory distress or shortness of breath persists 20 minutes after the start of the first treatment, administer a second treatment.
Standard of care therapies: Will receive standard of care therapies for the treatment of CoViD-19 infection and symptoms
|
Standard of Care Alone
n=11 Participants
Will receive standard of care therapies to treat CoViD-19 infection and symptoms
Standard of care therapies: Will receive standard of care therapies for the treatment of CoViD-19 infection and symptoms
|
|---|---|---|
|
Number of Participants With Clinical Events
Number of participants with SAE
|
5 Participants
|
5 Participants
|
|
Number of Participants With Clinical Events
Number of participants intubated while hospitalized for COVID-19
|
1 Participants
|
1 Participants
|
|
Number of Participants With Clinical Events
Death up to 90 days post-discharge
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: From baseline to discharge from hospital or death while hospitalized (patients had data for up to 6.2 days on average after baseline for these outcomes)measure the changes in the serum/plasma concentrations of CRP
Outcome measures
| Measure |
gammaCore Sapphire® (nVNS) Plus Standard of Care
n=10 Participants
Subjects will be administered study treatment with the nVNS device 3 times per day (prophylaxis) and also as needed for acute respiratory symptoms.
gammaCore® Sapphire (non-invasive vagus nerve stimulator): Administer gammaCore® Sapphire daily, prophylactically, for three treatments (morning, mid-day and night, one hour before bed), each treatment consisting of two 2-minute doses/stimulations, one on each side of the neck. This would be a total of 6 treatments (2 doses x 3 times per day) of stimulation.
For acute respiratory distress or shortness of breath (SOB), administer one treatment consisting of two 2-minute stimulations, on the neck. If respiratory distress or shortness of breath persists 20 minutes after the start of the first treatment, administer a second treatment.
Standard of care therapies: Will receive standard of care therapies for the treatment of CoViD-19 infection and symptoms
|
Standard of Care Alone
n=11 Participants
Will receive standard of care therapies to treat CoViD-19 infection and symptoms
Standard of care therapies: Will receive standard of care therapies for the treatment of CoViD-19 infection and symptoms
|
|---|---|---|
|
Evaluate C-reactive Protein (CRP) Trends
CRP baseline
|
13.7 milligrams per deciliter
Interval 0.0 to 34.0
|
7.7 milligrams per deciliter
Interval 1.3 to 14.2
|
|
Evaluate C-reactive Protein (CRP) Trends
CRP Peak
|
17.4 milligrams per deciliter
Interval 0.0 to 39.3
|
14 milligrams per deciliter
Interval 1.9 to 42.5
|
|
Evaluate C-reactive Protein (CRP) Trends
CRP at discharge or death
|
2.6 milligrams per deciliter
Interval 0.0 to 7.9
|
5.1 milligrams per deciliter
Interval 0.0 to 36.9
|
SECONDARY outcome
Timeframe: From baseline to discharge from hospital or death while hospitalized (patients had data for up to 6.2 days on average after baseline for these outcomes)compare the difference in oxygen requirements (liters/min) between the control group and active group for patients admitted to the hospital for CoViD-19.
Outcome measures
| Measure |
gammaCore Sapphire® (nVNS) Plus Standard of Care
n=10 Participants
Subjects will be administered study treatment with the nVNS device 3 times per day (prophylaxis) and also as needed for acute respiratory symptoms.
gammaCore® Sapphire (non-invasive vagus nerve stimulator): Administer gammaCore® Sapphire daily, prophylactically, for three treatments (morning, mid-day and night, one hour before bed), each treatment consisting of two 2-minute doses/stimulations, one on each side of the neck. This would be a total of 6 treatments (2 doses x 3 times per day) of stimulation.
For acute respiratory distress or shortness of breath (SOB), administer one treatment consisting of two 2-minute stimulations, on the neck. If respiratory distress or shortness of breath persists 20 minutes after the start of the first treatment, administer a second treatment.
Standard of care therapies: Will receive standard of care therapies for the treatment of CoViD-19 infection and symptoms
|
Standard of Care Alone
n=11 Participants
Will receive standard of care therapies to treat CoViD-19 infection and symptoms
Standard of care therapies: Will receive standard of care therapies for the treatment of CoViD-19 infection and symptoms
|
|---|---|---|
|
Evaluate Supplemental Oxygen Requirements
highest FiO2 requirement while hospitalized
|
54.4 fraction of inspired oxygen (percentage)
Interval 28.0 to 100.0
|
57.3 fraction of inspired oxygen (percentage)
Interval 21.0 to 100.0
|
|
Evaluate Supplemental Oxygen Requirements
FiO2 requirement at discharge
|
29.2 fraction of inspired oxygen (percentage)
Interval 21.0 to 52.0
|
30.8 fraction of inspired oxygen (percentage)
Interval 21.0 to 100.0
|
SECONDARY outcome
Timeframe: From baseline to discharge from hospital or death while hospitalized (patients had data for up to 6.2 days on average after baseline for these outcomes)number of participant deaths due to Covid-19
Outcome measures
| Measure |
gammaCore Sapphire® (nVNS) Plus Standard of Care
n=10 Participants
Subjects will be administered study treatment with the nVNS device 3 times per day (prophylaxis) and also as needed for acute respiratory symptoms.
gammaCore® Sapphire (non-invasive vagus nerve stimulator): Administer gammaCore® Sapphire daily, prophylactically, for three treatments (morning, mid-day and night, one hour before bed), each treatment consisting of two 2-minute doses/stimulations, one on each side of the neck. This would be a total of 6 treatments (2 doses x 3 times per day) of stimulation.
For acute respiratory distress or shortness of breath (SOB), administer one treatment consisting of two 2-minute stimulations, on the neck. If respiratory distress or shortness of breath persists 20 minutes after the start of the first treatment, administer a second treatment.
Standard of care therapies: Will receive standard of care therapies for the treatment of CoViD-19 infection and symptoms
|
Standard of Care Alone
n=11 Participants
Will receive standard of care therapies to treat CoViD-19 infection and symptoms
Standard of care therapies: Will receive standard of care therapies for the treatment of CoViD-19 infection and symptoms
|
|---|---|---|
|
Number of Participant Deaths
|
0 number of deaths
|
1 number of deaths
|
SECONDARY outcome
Timeframe: From baseline to discharge from hospital or death while hospitalizedPopulation: Note that only one patient in each group required mechanical ventilation.
Time to mechanical ventilation between control group and treatment group (for patients who progress to the need for mechanical ventilation)
Outcome measures
| Measure |
gammaCore Sapphire® (nVNS) Plus Standard of Care
n=1 Participants
Subjects will be administered study treatment with the nVNS device 3 times per day (prophylaxis) and also as needed for acute respiratory symptoms.
gammaCore® Sapphire (non-invasive vagus nerve stimulator): Administer gammaCore® Sapphire daily, prophylactically, for three treatments (morning, mid-day and night, one hour before bed), each treatment consisting of two 2-minute doses/stimulations, one on each side of the neck. This would be a total of 6 treatments (2 doses x 3 times per day) of stimulation.
For acute respiratory distress or shortness of breath (SOB), administer one treatment consisting of two 2-minute stimulations, on the neck. If respiratory distress or shortness of breath persists 20 minutes after the start of the first treatment, administer a second treatment.
Standard of care therapies: Will receive standard of care therapies for the treatment of CoViD-19 infection and symptoms
|
Standard of Care Alone
n=1 Participants
Will receive standard of care therapies to treat CoViD-19 infection and symptoms
Standard of care therapies: Will receive standard of care therapies for the treatment of CoViD-19 infection and symptoms
|
|---|---|---|
|
Time to Onset of Mechanical Ventilation
|
9.0 days
|
15.3 days
|
SECONDARY outcome
Timeframe: From baseline to discharge from hospital or death while hospitalized (data not collected during the study for this outcome)Population: incomplete sample size due to early termination, did not collect WHO data for analysis
World Health Organization (WHO) Ordinal Scale for Clinical Improvement.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From baseline to discharge from hospital or death while hospitalized (patients had data for up to 6.2 days on average after baseline for these outcomes)measure the changes in the serum/plasma concentrations of Ferritin
Outcome measures
| Measure |
gammaCore Sapphire® (nVNS) Plus Standard of Care
n=10 Participants
Subjects will be administered study treatment with the nVNS device 3 times per day (prophylaxis) and also as needed for acute respiratory symptoms.
gammaCore® Sapphire (non-invasive vagus nerve stimulator): Administer gammaCore® Sapphire daily, prophylactically, for three treatments (morning, mid-day and night, one hour before bed), each treatment consisting of two 2-minute doses/stimulations, one on each side of the neck. This would be a total of 6 treatments (2 doses x 3 times per day) of stimulation.
For acute respiratory distress or shortness of breath (SOB), administer one treatment consisting of two 2-minute stimulations, on the neck. If respiratory distress or shortness of breath persists 20 minutes after the start of the first treatment, administer a second treatment.
Standard of care therapies: Will receive standard of care therapies for the treatment of CoViD-19 infection and symptoms
|
Standard of Care Alone
n=11 Participants
Will receive standard of care therapies to treat CoViD-19 infection and symptoms
Standard of care therapies: Will receive standard of care therapies for the treatment of CoViD-19 infection and symptoms
|
|---|---|---|
|
Evaluate Ferritin Levels/Trends
Ferritin baseline
|
915.6 nanograms per mililiter
Interval 87.0 to 2209.0
|
762.9 nanograms per mililiter
Interval 54.0 to 2903.0
|
|
Evaluate Ferritin Levels/Trends
Ferritin Peak
|
1256.6 nanograms per mililiter
Interval 178.6 to 3307.0
|
1463.9 nanograms per mililiter
Interval 205.0 to 6655.0
|
|
Evaluate Ferritin Levels/Trends
Ferritin at discharge or death
|
704.2 nanograms per mililiter
Interval 136.7 to 1858.0
|
1124.9 nanograms per mililiter
Interval 67.0 to 6655.0
|
SECONDARY outcome
Timeframe: From baseline to discharge from hospital or death while hospitalized (patients had data for up to 6.2 days on average after baseline for these outcomes)measure the changes in the serum/plasma concentrations of D-Dimer
Outcome measures
| Measure |
gammaCore Sapphire® (nVNS) Plus Standard of Care
n=10 Participants
Subjects will be administered study treatment with the nVNS device 3 times per day (prophylaxis) and also as needed for acute respiratory symptoms.
gammaCore® Sapphire (non-invasive vagus nerve stimulator): Administer gammaCore® Sapphire daily, prophylactically, for three treatments (morning, mid-day and night, one hour before bed), each treatment consisting of two 2-minute doses/stimulations, one on each side of the neck. This would be a total of 6 treatments (2 doses x 3 times per day) of stimulation.
For acute respiratory distress or shortness of breath (SOB), administer one treatment consisting of two 2-minute stimulations, on the neck. If respiratory distress or shortness of breath persists 20 minutes after the start of the first treatment, administer a second treatment.
Standard of care therapies: Will receive standard of care therapies for the treatment of CoViD-19 infection and symptoms
|
Standard of Care Alone
n=11 Participants
Will receive standard of care therapies to treat CoViD-19 infection and symptoms
Standard of care therapies: Will receive standard of care therapies for the treatment of CoViD-19 infection and symptoms
|
|---|---|---|
|
Evaluate D-dimer Trends/Levels
D-Dimer baseline
|
5.0 mcg per mL fibrinogen equivalent unit
Interval 0.8 to 14.1
|
1.0 mcg per mL fibrinogen equivalent unit
Interval 0.4 to 1.9
|
|
Evaluate D-dimer Trends/Levels
D-Dimer Peak
|
7.9 mcg per mL fibrinogen equivalent unit
Interval 1.0 to 19.1
|
3.7 mcg per mL fibrinogen equivalent unit
Interval 1.0 to 20.0
|
|
Evaluate D-dimer Trends/Levels
D-Dimer at discharge or death
|
1.8 mcg per mL fibrinogen equivalent unit
Interval 0.4 to 10.5
|
2.2 mcg per mL fibrinogen equivalent unit
Interval 0.4 to 13.2
|
SECONDARY outcome
Timeframe: From baseline to discharge from hospital or death while hospitalized (patients had data for up to 6.2 days on average after baseline for these outcomes)Population: 1 participant in the treatment arm did not have Pro-Calcitonin drawn at any timepoints; 1 participant in control arm did not have discharge Pro-calcitonin drawn
measure the changes in the serum/plasma concentrations of Pro-Calcitonin
Outcome measures
| Measure |
gammaCore Sapphire® (nVNS) Plus Standard of Care
n=10 Participants
Subjects will be administered study treatment with the nVNS device 3 times per day (prophylaxis) and also as needed for acute respiratory symptoms.
gammaCore® Sapphire (non-invasive vagus nerve stimulator): Administer gammaCore® Sapphire daily, prophylactically, for three treatments (morning, mid-day and night, one hour before bed), each treatment consisting of two 2-minute doses/stimulations, one on each side of the neck. This would be a total of 6 treatments (2 doses x 3 times per day) of stimulation.
For acute respiratory distress or shortness of breath (SOB), administer one treatment consisting of two 2-minute stimulations, on the neck. If respiratory distress or shortness of breath persists 20 minutes after the start of the first treatment, administer a second treatment.
Standard of care therapies: Will receive standard of care therapies for the treatment of CoViD-19 infection and symptoms
|
Standard of Care Alone
n=11 Participants
Will receive standard of care therapies to treat CoViD-19 infection and symptoms
Standard of care therapies: Will receive standard of care therapies for the treatment of CoViD-19 infection and symptoms
|
|---|---|---|
|
Evaluate Pro-Calcitonin (PCT) Levels/Trends
Pro-Calcitonin baseline
|
2.9 nanograms per mililiter
Interval 0.06 to 23.8
|
0.2 nanograms per mililiter
Interval 0.08 to 0.54
|
|
Evaluate Pro-Calcitonin (PCT) Levels/Trends
Pro-Calcitonin Peak
|
2.9 nanograms per mililiter
Interval 0.06 to 23.8
|
1.1 nanograms per mililiter
Interval 0.08 to 9.84
|
|
Evaluate Pro-Calcitonin (PCT) Levels/Trends
Pro-Calcitonin at discharge or death
|
0.1 nanograms per mililiter
Interval 0.04 to 0.32
|
1.0 nanograms per mililiter
Interval 0.04 to 9.84
|
SECONDARY outcome
Timeframe: From baseline up to 7 days, discharge or death (whichever occurred first)Population: The analysis population was determined for study day 0, 1, 2, 3, 5 and 7 based on how many patients were still enrolled in the study on that day and had cytokine data that could be evaluated.
The level of the cytokine TNF-α in serum/plasma, as measured using ELISA.
Outcome measures
| Measure |
gammaCore Sapphire® (nVNS) Plus Standard of Care
n=10 Participants
Subjects will be administered study treatment with the nVNS device 3 times per day (prophylaxis) and also as needed for acute respiratory symptoms.
gammaCore® Sapphire (non-invasive vagus nerve stimulator): Administer gammaCore® Sapphire daily, prophylactically, for three treatments (morning, mid-day and night, one hour before bed), each treatment consisting of two 2-minute doses/stimulations, one on each side of the neck. This would be a total of 6 treatments (2 doses x 3 times per day) of stimulation.
For acute respiratory distress or shortness of breath (SOB), administer one treatment consisting of two 2-minute stimulations, on the neck. If respiratory distress or shortness of breath persists 20 minutes after the start of the first treatment, administer a second treatment.
Standard of care therapies: Will receive standard of care therapies for the treatment of CoViD-19 infection and symptoms
|
Standard of Care Alone
n=11 Participants
Will receive standard of care therapies to treat CoViD-19 infection and symptoms
Standard of care therapies: Will receive standard of care therapies for the treatment of CoViD-19 infection and symptoms
|
|---|---|---|
|
Evaluate Cytokine Trends (Serum/Plasma Level of TNF-α)
Day 0
|
17.1 pg/mL
Standard Deviation 23.1
|
77.9 pg/mL
Standard Deviation 164.7
|
|
Evaluate Cytokine Trends (Serum/Plasma Level of TNF-α)
Day 1
|
14.2 pg/mL
Standard Deviation 17.4
|
89.7 pg/mL
Standard Deviation 175.8
|
|
Evaluate Cytokine Trends (Serum/Plasma Level of TNF-α)
Day 2
|
14.8 pg/mL
Standard Deviation 16.8
|
83.5 pg/mL
Standard Deviation 183.1
|
|
Evaluate Cytokine Trends (Serum/Plasma Level of TNF-α)
Day 3
|
21.6 pg/mL
Standard Deviation 40.1
|
60.0 pg/mL
Standard Deviation 136.2
|
|
Evaluate Cytokine Trends (Serum/Plasma Level of TNF-α)
Day 5
|
20.6 pg/mL
Standard Deviation 31.6
|
73.9 pg/mL
Standard Deviation 132.2
|
|
Evaluate Cytokine Trends (Serum/Plasma Level of TNF-α)
Day 7
|
0.0 pg/mL
Standard Deviation NA
Standard deviation cannot be calculated because only one patient in this group had data for Day 7
|
15.6 pg/mL
Standard Deviation 14.4
|
SECONDARY outcome
Timeframe: From baseline up to 7 days, discharge or death (whichever occurred first)Population: The analysis population was determined for study day 0, 1, 2, 3, 5 and 7 based on how many patients were still enrolled in the study on that day and had cytokine data that could be evaluated.
The level of the cytokine IL-1β in serum/plasma, as measured using ELISA.
Outcome measures
| Measure |
gammaCore Sapphire® (nVNS) Plus Standard of Care
n=10 Participants
Subjects will be administered study treatment with the nVNS device 3 times per day (prophylaxis) and also as needed for acute respiratory symptoms.
gammaCore® Sapphire (non-invasive vagus nerve stimulator): Administer gammaCore® Sapphire daily, prophylactically, for three treatments (morning, mid-day and night, one hour before bed), each treatment consisting of two 2-minute doses/stimulations, one on each side of the neck. This would be a total of 6 treatments (2 doses x 3 times per day) of stimulation.
For acute respiratory distress or shortness of breath (SOB), administer one treatment consisting of two 2-minute stimulations, on the neck. If respiratory distress or shortness of breath persists 20 minutes after the start of the first treatment, administer a second treatment.
Standard of care therapies: Will receive standard of care therapies for the treatment of CoViD-19 infection and symptoms
|
Standard of Care Alone
n=11 Participants
Will receive standard of care therapies to treat CoViD-19 infection and symptoms
Standard of care therapies: Will receive standard of care therapies for the treatment of CoViD-19 infection and symptoms
|
|---|---|---|
|
Evaluate Cytokine Trends (Serum/Plasma Level of IL-1β)
Day 0
|
3.7 pg/mL
Standard Deviation 6.2
|
47.3 pg/mL
Standard Deviation 83.5
|
|
Evaluate Cytokine Trends (Serum/Plasma Level of IL-1β)
Day 1
|
4.4 pg/mL
Standard Deviation 7.3
|
53.4 pg/mL
Standard Deviation 98.8
|
|
Evaluate Cytokine Trends (Serum/Plasma Level of IL-1β)
Day 2
|
4.6 pg/mL
Standard Deviation 6.6
|
48.3 pg/mL
Standard Deviation 91.6
|
|
Evaluate Cytokine Trends (Serum/Plasma Level of IL-1β)
Day 3
|
5.9 pg/mL
Standard Deviation 9.0
|
42.9 pg/mL
Standard Deviation 86.8
|
|
Evaluate Cytokine Trends (Serum/Plasma Level of IL-1β)
Day 5
|
2.2 pg/mL
Standard Deviation 3.8
|
65.1 pg/mL
Standard Deviation 105.5
|
|
Evaluate Cytokine Trends (Serum/Plasma Level of IL-1β)
Day 7
|
0.0 pg/mL
Standard Deviation NA
Standard deviation cannot be calculated because only one patient in this group had data for Day 7
|
17.3 pg/mL
Standard Deviation 26.9
|
SECONDARY outcome
Timeframe: From baseline up to 7 days, discharge or death (whichever occurred first)Population: The analysis population was determined for study day 0, 1, 2, 3, 5 and 7 based on how many patients were still enrolled in the study on that day and had cytokine data that could be evaluated.
The level of the cytokine IL-6 in serum/plasma, as measured using ELISA.
Outcome measures
| Measure |
gammaCore Sapphire® (nVNS) Plus Standard of Care
n=10 Participants
Subjects will be administered study treatment with the nVNS device 3 times per day (prophylaxis) and also as needed for acute respiratory symptoms.
gammaCore® Sapphire (non-invasive vagus nerve stimulator): Administer gammaCore® Sapphire daily, prophylactically, for three treatments (morning, mid-day and night, one hour before bed), each treatment consisting of two 2-minute doses/stimulations, one on each side of the neck. This would be a total of 6 treatments (2 doses x 3 times per day) of stimulation.
For acute respiratory distress or shortness of breath (SOB), administer one treatment consisting of two 2-minute stimulations, on the neck. If respiratory distress or shortness of breath persists 20 minutes after the start of the first treatment, administer a second treatment.
Standard of care therapies: Will receive standard of care therapies for the treatment of CoViD-19 infection and symptoms
|
Standard of Care Alone
n=11 Participants
Will receive standard of care therapies to treat CoViD-19 infection and symptoms
Standard of care therapies: Will receive standard of care therapies for the treatment of CoViD-19 infection and symptoms
|
|---|---|---|
|
Evaluate Cytokine Trends (Serum/Plasma Level of IL-6)
Day 3
|
60.8 pg/mL
Standard Deviation 92.9
|
69.0 pg/mL
Standard Deviation 64.4
|
|
Evaluate Cytokine Trends (Serum/Plasma Level of IL-6)
Day 0
|
101.7 pg/mL
Standard Deviation 129.2
|
68.9 pg/mL
Standard Deviation 66.7
|
|
Evaluate Cytokine Trends (Serum/Plasma Level of IL-6)
Day 1
|
58.7 pg/mL
Standard Deviation 89.7
|
74.7 pg/mL
Standard Deviation 65.0
|
|
Evaluate Cytokine Trends (Serum/Plasma Level of IL-6)
Day 2
|
82.9 pg/mL
Standard Deviation 141.0
|
63.3 pg/mL
Standard Deviation 54.5
|
|
Evaluate Cytokine Trends (Serum/Plasma Level of IL-6)
Day 5
|
114.7 pg/mL
Standard Deviation 167.6
|
60.8 pg/mL
Standard Deviation 65.3
|
|
Evaluate Cytokine Trends (Serum/Plasma Level of IL-6)
Day 7
|
0.0 pg/mL
Standard Deviation NA
Standard deviation cannot be calculated because only one patient in this group had data for Day 7
|
35.3 pg/mL
Standard Deviation 20.5
|
Adverse Events
gammaCore Sapphire® (nVNS) Plus Standard of Care
Serious events: 5 serious events
Other events: 2 other events
Deaths: 0 deaths
Standard of Care Alone
Serious events: 5 serious events
Other events: 2 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
gammaCore Sapphire® (nVNS) Plus Standard of Care
n=10 participants at risk
Subjects will be administered study treatment with the nVNS device 3 times per day (prophylaxis) and also as needed for acute respiratory symptoms.
gammaCore® Sapphire (non-invasive vagus nerve stimulator): Administer gammaCore® Sapphire daily, prophylactically, for three treatments (morning, mid-day and night, one hour before bed), each treatment consisting of two 2-minute doses/stimulations, one on each side of the neck. This would be a total of 6 treatments (2 doses x 3 times per day) of stimulation.
For acute respiratory distress or shortness of breath (SOB), administer one treatment consisting of two 2-minute stimulations, on the neck. If respiratory distress or shortness of breath persists 20 minutes after the start of the first treatment, administer a second treatment.
Standard of care therapies: Will receive standard of care therapies for the treatment of CoViD-19 infection and symptoms
|
Standard of Care Alone
n=11 participants at risk
Will receive standard of care therapies to treat CoViD-19 infection and symptoms
Standard of care therapies: Will receive standard of care therapies for the treatment of CoViD-19 infection and symptoms
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic chest pain
|
10.0%
1/10 • Number of events 1 • up to 3 months post discharge, an average of 3.5 months
|
0.00%
0/11 • up to 3 months post discharge, an average of 3.5 months
|
|
Musculoskeletal and connective tissue disorders
critical illness myopathy
|
10.0%
1/10 • Number of events 1 • up to 3 months post discharge, an average of 3.5 months
|
0.00%
0/11 • up to 3 months post discharge, an average of 3.5 months
|
|
Respiratory, thoracic and mediastinal disorders
acute respiratory failure
|
20.0%
2/10 • Number of events 2 • up to 3 months post discharge, an average of 3.5 months
|
18.2%
2/11 • Number of events 2 • up to 3 months post discharge, an average of 3.5 months
|
|
Respiratory, thoracic and mediastinal disorders
pulmonary embolism
|
20.0%
2/10 • Number of events 2 • up to 3 months post discharge, an average of 3.5 months
|
9.1%
1/11 • Number of events 1 • up to 3 months post discharge, an average of 3.5 months
|
|
Nervous system disorders
encephalopathy
|
10.0%
1/10 • Number of events 1 • up to 3 months post discharge, an average of 3.5 months
|
0.00%
0/11 • up to 3 months post discharge, an average of 3.5 months
|
|
Blood and lymphatic system disorders
bacteremia
|
10.0%
1/10 • Number of events 1 • up to 3 months post discharge, an average of 3.5 months
|
0.00%
0/11 • up to 3 months post discharge, an average of 3.5 months
|
|
Blood and lymphatic system disorders
deep vein thrombosis
|
10.0%
1/10 • Number of events 1 • up to 3 months post discharge, an average of 3.5 months
|
0.00%
0/11 • up to 3 months post discharge, an average of 3.5 months
|
|
Surgical and medical procedures
tracheostomy
|
10.0%
1/10 • Number of events 1 • up to 3 months post discharge, an average of 3.5 months
|
0.00%
0/11 • up to 3 months post discharge, an average of 3.5 months
|
|
Gastrointestinal disorders
severe malnutrition
|
10.0%
1/10 • Number of events 1 • up to 3 months post discharge, an average of 3.5 months
|
0.00%
0/11 • up to 3 months post discharge, an average of 3.5 months
|
|
Infections and infestations
Urachal diverticulum infection
|
10.0%
1/10 • Number of events 1 • up to 3 months post discharge, an average of 3.5 months
|
0.00%
0/11 • up to 3 months post discharge, an average of 3.5 months
|
|
Blood and lymphatic system disorders
anemia
|
10.0%
1/10 • Number of events 1 • up to 3 months post discharge, an average of 3.5 months
|
0.00%
0/11 • up to 3 months post discharge, an average of 3.5 months
|
|
Renal and urinary disorders
Acute kidney injury
|
10.0%
1/10 • Number of events 1 • up to 3 months post discharge, an average of 3.5 months
|
9.1%
1/11 • Number of events 1 • up to 3 months post discharge, an average of 3.5 months
|
|
Cardiac disorders
hypertension
|
0.00%
0/10 • up to 3 months post discharge, an average of 3.5 months
|
9.1%
1/11 • Number of events 1 • up to 3 months post discharge, an average of 3.5 months
|
|
Surgical and medical procedures
intubation
|
10.0%
1/10 • Number of events 1 • up to 3 months post discharge, an average of 3.5 months
|
9.1%
1/11 • Number of events 1 • up to 3 months post discharge, an average of 3.5 months
|
|
Psychiatric disorders
anxiety
|
10.0%
1/10 • Number of events 1 • up to 3 months post discharge, an average of 3.5 months
|
9.1%
1/11 • Number of events 1 • up to 3 months post discharge, an average of 3.5 months
|
|
Cardiac disorders
atrial fibrillation
|
0.00%
0/10 • up to 3 months post discharge, an average of 3.5 months
|
9.1%
1/11 • Number of events 1 • up to 3 months post discharge, an average of 3.5 months
|
|
Respiratory, thoracic and mediastinal disorders
exertional hypoxia
|
0.00%
0/10 • up to 3 months post discharge, an average of 3.5 months
|
9.1%
1/11 • Number of events 1 • up to 3 months post discharge, an average of 3.5 months
|
Other adverse events
| Measure |
gammaCore Sapphire® (nVNS) Plus Standard of Care
n=10 participants at risk
Subjects will be administered study treatment with the nVNS device 3 times per day (prophylaxis) and also as needed for acute respiratory symptoms.
gammaCore® Sapphire (non-invasive vagus nerve stimulator): Administer gammaCore® Sapphire daily, prophylactically, for three treatments (morning, mid-day and night, one hour before bed), each treatment consisting of two 2-minute doses/stimulations, one on each side of the neck. This would be a total of 6 treatments (2 doses x 3 times per day) of stimulation.
For acute respiratory distress or shortness of breath (SOB), administer one treatment consisting of two 2-minute stimulations, on the neck. If respiratory distress or shortness of breath persists 20 minutes after the start of the first treatment, administer a second treatment.
Standard of care therapies: Will receive standard of care therapies for the treatment of CoViD-19 infection and symptoms
|
Standard of Care Alone
n=11 participants at risk
Will receive standard of care therapies to treat CoViD-19 infection and symptoms
Standard of care therapies: Will receive standard of care therapies for the treatment of CoViD-19 infection and symptoms
|
|---|---|---|
|
General disorders
fatigue
|
10.0%
1/10 • Number of events 1 • up to 3 months post discharge, an average of 3.5 months
|
9.1%
1/11 • Number of events 1 • up to 3 months post discharge, an average of 3.5 months
|
|
Cardiac disorders
hypertension
|
10.0%
1/10 • Number of events 1 • up to 3 months post discharge, an average of 3.5 months
|
0.00%
0/11 • up to 3 months post discharge, an average of 3.5 months
|
|
Cardiac disorders
tachycardia
|
0.00%
0/10 • up to 3 months post discharge, an average of 3.5 months
|
9.1%
1/11 • Number of events 1 • up to 3 months post discharge, an average of 3.5 months
|
Additional Information
Tariq Cheema, MD, Vice President and Medical Director AHN Research Institute
Allegheny Health Network (AHN)
Phone: 412-321-3344
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place