Trial Outcomes & Findings for Sodium Pyruvate Nasal Spray Treatment of COVID-19 Infection (NCT NCT04824365)
NCT ID: NCT04824365
Last Updated: 2022-11-02
Results Overview
RT-PCR was used to assess viral titers from nasal swabs from COVID19 patients. Swabs were collected and tested every 2 days for 14 days.
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
30 participants
Primary outcome timeframe
Day 0, 2, 4, 6, 8, 10, 12, and 14
Results posted on
2022-11-02
Participant Flow
Participant milestones
| Measure |
Treatment of COVID-19 Infected Patients With a Sodium Pyruvate Nasal Spray
In this arm, patients will be provided with N115 sodium pyruvate nasal spray and instructed to use it 3x daily for 14 days. This group will be compared to the placebo control group to determine if sodium pyruvate reduces the symptoms, duration and replication of COVID-19 infections.
Sodium Pyruvate: Subjects will use a sodium pyruvate nasal spray 3x daily for 14 days.
|
Placebo Control Treatment of COVID-19 Infected Patients
In this arm, patients will be provided with a saline nasal spray as a placebo control. Patients will use the saline nasal spray 3x daily for 14 days, similar to the sodium pyruvate drug arm. This will serve as a control for the symptoms, duration and replication of COVID-19 infections.
Saline: Subjects will use a saline nasal spray 3x daily for 14 days.
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
15
|
|
Overall Study
COMPLETED
|
15
|
15
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Sodium Pyruvate Nasal Spray Treatment of COVID-19 Infection
Baseline characteristics by cohort
| Measure |
Treatment of COVID-19 Infected Patients With a Sodium Pyruvate Nasal Spray
n=15 Participants
In this arm, patients will be provided with N115 sodium pyruvate nasal spray and instructed to use it 3x daily for 14 days. This group will be compared to the placebo control group to determine if sodium pyruvate reduces the symptoms, duration and replication of COVID-19 infections.
Sodium Pyruvate: Subjects will use a sodium pyruvate nasal spray 3x daily for 14 days.
|
Placebo Control Treatment of COVID-19 Infected Patients
n=15 Participants
In this arm, patients will be provided with a saline nasal spray as a placebo control. Patients will use the saline nasal spray 3x daily for 14 days, similar to the sodium pyruvate drug arm. This will serve as a control for the symptoms, duration and replication of COVID-19 infections.
Saline: Subjects will use a saline nasal spray 3x daily for 14 days.
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
53.2 years
STANDARD_DEVIATION 17.57 • n=99 Participants
|
54.73 years
STANDARD_DEVIATION 19.51 • n=107 Participants
|
53.97 years
STANDARD_DEVIATION 18.26 • n=206 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
23 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
15 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
30 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
15 participants
n=99 Participants
|
15 participants
n=107 Participants
|
30 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Day 0, 2, 4, 6, 8, 10, 12, and 14RT-PCR was used to assess viral titers from nasal swabs from COVID19 patients. Swabs were collected and tested every 2 days for 14 days.
Outcome measures
| Measure |
Treatment of COVID-19 Infected Patients With a Sodium Pyruvate Nasal Spray
n=15 Participants
In this arm, patients will be provided with N115 sodium pyruvate nasal spray and instructed to use it 3x daily for 14 days. This group will be compared to the placebo control group to determine if sodium pyruvate reduces the symptoms, duration and replication of COVID-19 infections.
Sodium Pyruvate: Subjects will use a sodium pyruvate nasal spray 3x daily for 14 days.
|
Placebo Control Treatment of COVID-19 Infected Patients
n=15 Participants
In this arm, patients will be provided with a saline nasal spray as a placebo control. Patients will use the saline nasal spray 3x daily for 14 days, similar to the sodium pyruvate drug arm. This will serve as a control for the symptoms, duration and replication of COVID-19 infections.
Saline: Subjects will use a saline nasal spray 3x daily for 14 days.
|
|---|---|---|
|
Evaluate the Ability of Inhaled Nasal Sodium Pyruvate to Change COVID-19 Viral Titers.
Day 0
|
5.61 Log10 viral RNA copies
Standard Error 0.26
|
6.57 Log10 viral RNA copies
Standard Error 0.24
|
|
Evaluate the Ability of Inhaled Nasal Sodium Pyruvate to Change COVID-19 Viral Titers.
Day 2
|
4.67 Log10 viral RNA copies
Standard Error 0.26
|
5.86 Log10 viral RNA copies
Standard Error 0.20
|
|
Evaluate the Ability of Inhaled Nasal Sodium Pyruvate to Change COVID-19 Viral Titers.
Day 4
|
4.27 Log10 viral RNA copies
Standard Error 0.26
|
5.18 Log10 viral RNA copies
Standard Error 0.21
|
|
Evaluate the Ability of Inhaled Nasal Sodium Pyruvate to Change COVID-19 Viral Titers.
Day 6
|
3.88 Log10 viral RNA copies
Standard Error 0.31
|
4.55 Log10 viral RNA copies
Standard Error 0.22
|
|
Evaluate the Ability of Inhaled Nasal Sodium Pyruvate to Change COVID-19 Viral Titers.
Day 8
|
3.48 Log10 viral RNA copies
Standard Error 0.34
|
4.11 Log10 viral RNA copies
Standard Error 0.20
|
|
Evaluate the Ability of Inhaled Nasal Sodium Pyruvate to Change COVID-19 Viral Titers.
Day 10
|
3.18 Log10 viral RNA copies
Standard Error 0.24
|
3.71 Log10 viral RNA copies
Standard Error 0.25
|
|
Evaluate the Ability of Inhaled Nasal Sodium Pyruvate to Change COVID-19 Viral Titers.
Day 12
|
2.96 Log10 viral RNA copies
Standard Error 0.23
|
3.35 Log10 viral RNA copies
Standard Error 0.34
|
|
Evaluate the Ability of Inhaled Nasal Sodium Pyruvate to Change COVID-19 Viral Titers.
Day 14
|
2.34 Log10 viral RNA copies
Standard Error 0.11
|
2.78 Log10 viral RNA copies
Standard Error 0.39
|
PRIMARY outcome
Timeframe: Day 0, 2, 4, 6, 8, 10, 12, and 14Percent SaO2 was measured every other day by clinic staff.
Outcome measures
| Measure |
Treatment of COVID-19 Infected Patients With a Sodium Pyruvate Nasal Spray
n=15 Participants
In this arm, patients will be provided with N115 sodium pyruvate nasal spray and instructed to use it 3x daily for 14 days. This group will be compared to the placebo control group to determine if sodium pyruvate reduces the symptoms, duration and replication of COVID-19 infections.
Sodium Pyruvate: Subjects will use a sodium pyruvate nasal spray 3x daily for 14 days.
|
Placebo Control Treatment of COVID-19 Infected Patients
n=15 Participants
In this arm, patients will be provided with a saline nasal spray as a placebo control. Patients will use the saline nasal spray 3x daily for 14 days, similar to the sodium pyruvate drug arm. This will serve as a control for the symptoms, duration and replication of COVID-19 infections.
Saline: Subjects will use a saline nasal spray 3x daily for 14 days.
|
|---|---|---|
|
Evaluate the Ability of Inhaled Nasal Sodium Pyruvate to Affect SaO2 in COVID-19 Infected Patients.
Day 0
|
95.73 % Blood oxygen saturation
Standard Deviation 0.96
|
95.4 % Blood oxygen saturation
Standard Deviation 0.83
|
|
Evaluate the Ability of Inhaled Nasal Sodium Pyruvate to Affect SaO2 in COVID-19 Infected Patients.
Day 2
|
95.6 % Blood oxygen saturation
Standard Deviation 0.99
|
95.73 % Blood oxygen saturation
Standard Deviation 0.59
|
|
Evaluate the Ability of Inhaled Nasal Sodium Pyruvate to Affect SaO2 in COVID-19 Infected Patients.
Day 4
|
95.67 % Blood oxygen saturation
Standard Deviation 0.82
|
95.8 % Blood oxygen saturation
Standard Deviation 0.77
|
|
Evaluate the Ability of Inhaled Nasal Sodium Pyruvate to Affect SaO2 in COVID-19 Infected Patients.
Day 6
|
96.07 % Blood oxygen saturation
Standard Deviation 1.22
|
96.43 % Blood oxygen saturation
Standard Deviation 0.76
|
|
Evaluate the Ability of Inhaled Nasal Sodium Pyruvate to Affect SaO2 in COVID-19 Infected Patients.
Day 8
|
96.93 % Blood oxygen saturation
Standard Deviation 1.03
|
96.71 % Blood oxygen saturation
Standard Deviation 0.91
|
|
Evaluate the Ability of Inhaled Nasal Sodium Pyruvate to Affect SaO2 in COVID-19 Infected Patients.
Day 10
|
97.33 % Blood oxygen saturation
Standard Deviation 0.82
|
97.21 % Blood oxygen saturation
Standard Deviation 0.97
|
|
Evaluate the Ability of Inhaled Nasal Sodium Pyruvate to Affect SaO2 in COVID-19 Infected Patients.
Day 12
|
97.53 % Blood oxygen saturation
Standard Deviation 0.83
|
97.5 % Blood oxygen saturation
Standard Deviation 0.76
|
|
Evaluate the Ability of Inhaled Nasal Sodium Pyruvate to Affect SaO2 in COVID-19 Infected Patients.
Day 14
|
97.8 % Blood oxygen saturation
Standard Deviation 0.56
|
97.57 % Blood oxygen saturation
Standard Deviation 0.76
|
SECONDARY outcome
Timeframe: Twice daily (morning and evening) from Day 1-14To evaluate the ability of the N115 nasal spray to improve fever in COVID19 patients oral measurement of body temperature was assessed every morning and every evening for 14 days. Reported values are the average daily body temperature.
Outcome measures
| Measure |
Treatment of COVID-19 Infected Patients With a Sodium Pyruvate Nasal Spray
n=15 Participants
In this arm, patients will be provided with N115 sodium pyruvate nasal spray and instructed to use it 3x daily for 14 days. This group will be compared to the placebo control group to determine if sodium pyruvate reduces the symptoms, duration and replication of COVID-19 infections.
Sodium Pyruvate: Subjects will use a sodium pyruvate nasal spray 3x daily for 14 days.
|
Placebo Control Treatment of COVID-19 Infected Patients
n=15 Participants
In this arm, patients will be provided with a saline nasal spray as a placebo control. Patients will use the saline nasal spray 3x daily for 14 days, similar to the sodium pyruvate drug arm. This will serve as a control for the symptoms, duration and replication of COVID-19 infections.
Saline: Subjects will use a saline nasal spray 3x daily for 14 days.
|
|---|---|---|
|
Evaluate the Ability of Inhaled Nasal Sodium Pyruvate to Affect Fever in COVID-19 Infected Patients.
Day 1
|
99.72 Degrees Fahrenheit
Standard Error 0.35
|
99.82 Degrees Fahrenheit
Standard Error 0.20
|
|
Evaluate the Ability of Inhaled Nasal Sodium Pyruvate to Affect Fever in COVID-19 Infected Patients.
Day 2
|
100.47 Degrees Fahrenheit
Standard Error 0.43
|
100.18 Degrees Fahrenheit
Standard Error 0.42
|
|
Evaluate the Ability of Inhaled Nasal Sodium Pyruvate to Affect Fever in COVID-19 Infected Patients.
Day 3
|
100.12 Degrees Fahrenheit
Standard Error 0.22
|
99.51 Degrees Fahrenheit
Standard Error 0.28
|
|
Evaluate the Ability of Inhaled Nasal Sodium Pyruvate to Affect Fever in COVID-19 Infected Patients.
Day 4
|
100.09 Degrees Fahrenheit
Standard Error 0.42
|
99.8 Degrees Fahrenheit
Standard Error 0.37
|
|
Evaluate the Ability of Inhaled Nasal Sodium Pyruvate to Affect Fever in COVID-19 Infected Patients.
Day 5
|
100.05 Degrees Fahrenheit
Standard Error 0.36
|
99.43 Degrees Fahrenheit
Standard Error 0.30
|
|
Evaluate the Ability of Inhaled Nasal Sodium Pyruvate to Affect Fever in COVID-19 Infected Patients.
Day 6
|
99.8 Degrees Fahrenheit
Standard Error 0.33
|
99.37 Degrees Fahrenheit
Standard Error 0.22
|
|
Evaluate the Ability of Inhaled Nasal Sodium Pyruvate to Affect Fever in COVID-19 Infected Patients.
Day 7
|
99.47 Degrees Fahrenheit
Standard Error 0.29
|
98.97 Degrees Fahrenheit
Standard Error 0.15
|
|
Evaluate the Ability of Inhaled Nasal Sodium Pyruvate to Affect Fever in COVID-19 Infected Patients.
Day 8
|
99.56 Degrees Fahrenheit
Standard Error 0.37
|
99.3 Degrees Fahrenheit
Standard Error 0.15
|
|
Evaluate the Ability of Inhaled Nasal Sodium Pyruvate to Affect Fever in COVID-19 Infected Patients.
Day 9
|
99.39 Degrees Fahrenheit
Standard Error 0.28
|
99.17 Degrees Fahrenheit
Standard Error 0.14
|
|
Evaluate the Ability of Inhaled Nasal Sodium Pyruvate to Affect Fever in COVID-19 Infected Patients.
Day 10
|
99.4 Degrees Fahrenheit
Standard Error 0.25
|
99.21 Degrees Fahrenheit
Standard Error 0.39
|
|
Evaluate the Ability of Inhaled Nasal Sodium Pyruvate to Affect Fever in COVID-19 Infected Patients.
Day 11
|
99.53 Degrees Fahrenheit
Standard Error 0.28
|
99.22 Degrees Fahrenheit
Standard Error 0.20
|
|
Evaluate the Ability of Inhaled Nasal Sodium Pyruvate to Affect Fever in COVID-19 Infected Patients.
Day 12
|
99.24 Degrees Fahrenheit
Standard Error 0.16
|
99.05 Degrees Fahrenheit
Standard Error 0.13
|
|
Evaluate the Ability of Inhaled Nasal Sodium Pyruvate to Affect Fever in COVID-19 Infected Patients.
Day 13
|
99.17 Degrees Fahrenheit
Standard Error 0.12
|
98.84 Degrees Fahrenheit
Standard Error 0.16
|
|
Evaluate the Ability of Inhaled Nasal Sodium Pyruvate to Affect Fever in COVID-19 Infected Patients.
Day 14
|
99.18 Degrees Fahrenheit
Standard Error 0.15
|
98.91 Degrees Fahrenheit
Standard Error 0.13
|
SECONDARY outcome
Timeframe: Daily from Day 1-14Population: Only patients that reported experiencing this symptom were included in the analysis.
Patients self reported the symptom in a patient log daily for 14 days. A Likert scale from 0-10 was used to rank the symptom severity, with 10 representing the most severe symptoms.
Outcome measures
| Measure |
Treatment of COVID-19 Infected Patients With a Sodium Pyruvate Nasal Spray
n=10 Participants
In this arm, patients will be provided with N115 sodium pyruvate nasal spray and instructed to use it 3x daily for 14 days. This group will be compared to the placebo control group to determine if sodium pyruvate reduces the symptoms, duration and replication of COVID-19 infections.
Sodium Pyruvate: Subjects will use a sodium pyruvate nasal spray 3x daily for 14 days.
|
Placebo Control Treatment of COVID-19 Infected Patients
n=8 Participants
In this arm, patients will be provided with a saline nasal spray as a placebo control. Patients will use the saline nasal spray 3x daily for 14 days, similar to the sodium pyruvate drug arm. This will serve as a control for the symptoms, duration and replication of COVID-19 infections.
Saline: Subjects will use a saline nasal spray 3x daily for 14 days.
|
|---|---|---|
|
Evaluate the Ability of Inhaled Nasal Sodium Pyruvate to Affect Body Aches in COVID-19 Infected Patients.
Day 1
|
6.4 units on a scale
Standard Deviation 2.67
|
5.13 units on a scale
Standard Deviation 2.85
|
|
Evaluate the Ability of Inhaled Nasal Sodium Pyruvate to Affect Body Aches in COVID-19 Infected Patients.
Day 2
|
6.4 units on a scale
Standard Deviation 2.67
|
5.13 units on a scale
Standard Deviation 2.85
|
|
Evaluate the Ability of Inhaled Nasal Sodium Pyruvate to Affect Body Aches in COVID-19 Infected Patients.
Day 3
|
6.4 units on a scale
Standard Deviation 2.67
|
4.88 units on a scale
Standard Deviation 2.8
|
|
Evaluate the Ability of Inhaled Nasal Sodium Pyruvate to Affect Body Aches in COVID-19 Infected Patients.
Day 4
|
6.0 units on a scale
Standard Deviation 1.94
|
4.75 units on a scale
Standard Deviation 2.6
|
|
Evaluate the Ability of Inhaled Nasal Sodium Pyruvate to Affect Body Aches in COVID-19 Infected Patients.
Day 5
|
5.9 units on a scale
Standard Deviation 1.79
|
4.25 units on a scale
Standard Deviation 2.49
|
|
Evaluate the Ability of Inhaled Nasal Sodium Pyruvate to Affect Body Aches in COVID-19 Infected Patients.
Day 6
|
5.5 units on a scale
Standard Deviation 2.12
|
4 units on a scale
Standard Deviation 2.56
|
|
Evaluate the Ability of Inhaled Nasal Sodium Pyruvate to Affect Body Aches in COVID-19 Infected Patients.
Day 7
|
5.3 units on a scale
Standard Deviation 2.21
|
3.5 units on a scale
Standard Deviation 2.45
|
|
Evaluate the Ability of Inhaled Nasal Sodium Pyruvate to Affect Body Aches in COVID-19 Infected Patients.
Day 8
|
5.6 units on a scale
Standard Deviation 2.59
|
3.25 units on a scale
Standard Deviation 2.6
|
|
Evaluate the Ability of Inhaled Nasal Sodium Pyruvate to Affect Body Aches in COVID-19 Infected Patients.
Day 9
|
5 units on a scale
Standard Deviation 2.4
|
3.125 units on a scale
Standard Deviation 2.42
|
|
Evaluate the Ability of Inhaled Nasal Sodium Pyruvate to Affect Body Aches in COVID-19 Infected Patients.
Day 10
|
5 units on a scale
Standard Deviation 2.4
|
3 units on a scale
Standard Deviation 2.51
|
|
Evaluate the Ability of Inhaled Nasal Sodium Pyruvate to Affect Body Aches in COVID-19 Infected Patients.
Day 11
|
4.4 units on a scale
Standard Deviation 2.22
|
2.375 units on a scale
Standard Deviation 2.56
|
|
Evaluate the Ability of Inhaled Nasal Sodium Pyruvate to Affect Body Aches in COVID-19 Infected Patients.
Day 12
|
4.1 units on a scale
Standard Deviation 2.08
|
2 units on a scale
Standard Deviation 2.39
|
|
Evaluate the Ability of Inhaled Nasal Sodium Pyruvate to Affect Body Aches in COVID-19 Infected Patients.
Day 13
|
3.6 units on a scale
Standard Deviation 2.27
|
1.75 units on a scale
Standard Deviation 1.98
|
|
Evaluate the Ability of Inhaled Nasal Sodium Pyruvate to Affect Body Aches in COVID-19 Infected Patients.
Day 14
|
3 units on a scale
Standard Deviation 1.83
|
1.63 units on a scale
Standard Deviation 1.92
|
SECONDARY outcome
Timeframe: Daily form day 1-14.Population: Only patients that reported experiencing this symptom were included in the analysis.
Patients self reported the symptom in a patient log daily for 14 days. A Likert scale from 0-10 was used to rank the symptom severity, with 10 representing the most severe symptoms.
Outcome measures
| Measure |
Treatment of COVID-19 Infected Patients With a Sodium Pyruvate Nasal Spray
n=4 Participants
In this arm, patients will be provided with N115 sodium pyruvate nasal spray and instructed to use it 3x daily for 14 days. This group will be compared to the placebo control group to determine if sodium pyruvate reduces the symptoms, duration and replication of COVID-19 infections.
Sodium Pyruvate: Subjects will use a sodium pyruvate nasal spray 3x daily for 14 days.
|
Placebo Control Treatment of COVID-19 Infected Patients
n=7 Participants
In this arm, patients will be provided with a saline nasal spray as a placebo control. Patients will use the saline nasal spray 3x daily for 14 days, similar to the sodium pyruvate drug arm. This will serve as a control for the symptoms, duration and replication of COVID-19 infections.
Saline: Subjects will use a saline nasal spray 3x daily for 14 days.
|
|---|---|---|
|
Evaluate the Ability of Inhaled Nasal Sodium Pyruvate to Affect Headaches in COVID-19 Infected Patients.
Day 1
|
4.25 units on a scale
Standard Deviation 3.1
|
3.14 units on a scale
Standard Deviation 2.79
|
|
Evaluate the Ability of Inhaled Nasal Sodium Pyruvate to Affect Headaches in COVID-19 Infected Patients.
Day 2
|
4.25 units on a scale
Standard Deviation 2.75
|
3.14 units on a scale
Standard Deviation 2.79
|
|
Evaluate the Ability of Inhaled Nasal Sodium Pyruvate to Affect Headaches in COVID-19 Infected Patients.
Day 3
|
4.75 units on a scale
Standard Deviation 2.22
|
2.86 units on a scale
Standard Deviation 2.27
|
|
Evaluate the Ability of Inhaled Nasal Sodium Pyruvate to Affect Headaches in COVID-19 Infected Patients.
Day 4
|
4.25 units on a scale
Standard Deviation 2.36
|
2.71 units on a scale
Standard Deviation 2.36
|
|
Evaluate the Ability of Inhaled Nasal Sodium Pyruvate to Affect Headaches in COVID-19 Infected Patients.
Day 5
|
4.25 units on a scale
Standard Deviation 2.22
|
2.29 units on a scale
Standard Deviation 1.89
|
|
Evaluate the Ability of Inhaled Nasal Sodium Pyruvate to Affect Headaches in COVID-19 Infected Patients.
Day 6
|
3.75 units on a scale
Standard Deviation 1.89
|
2.14 units on a scale
Standard Deviation 2.04
|
|
Evaluate the Ability of Inhaled Nasal Sodium Pyruvate to Affect Headaches in COVID-19 Infected Patients.
Day 7
|
3.75 units on a scale
Standard Deviation 2.50
|
2.00 units on a scale
Standard Deviation 1.83
|
|
Evaluate the Ability of Inhaled Nasal Sodium Pyruvate to Affect Headaches in COVID-19 Infected Patients.
Day 8
|
3.75 units on a scale
Standard Deviation 2.50
|
1.86 units on a scale
Standard Deviation 1.95
|
|
Evaluate the Ability of Inhaled Nasal Sodium Pyruvate to Affect Headaches in COVID-19 Infected Patients.
Day 9
|
3.50 units on a scale
Standard Deviation 2.38
|
1.57 units on a scale
Standard Deviation 1.51
|
|
Evaluate the Ability of Inhaled Nasal Sodium Pyruvate to Affect Headaches in COVID-19 Infected Patients.
Day 10
|
3.00 units on a scale
Standard Deviation 1.63
|
1.29 units on a scale
Standard Deviation 1.25
|
|
Evaluate the Ability of Inhaled Nasal Sodium Pyruvate to Affect Headaches in COVID-19 Infected Patients.
Day 11
|
3.00 units on a scale
Standard Deviation 1.36
|
1.14 units on a scale
Standard Deviation 1.07
|
|
Evaluate the Ability of Inhaled Nasal Sodium Pyruvate to Affect Headaches in COVID-19 Infected Patients.
Day 12
|
2.75 units on a scale
Standard Deviation 2.22
|
1.00 units on a scale
Standard Deviation 1.00
|
|
Evaluate the Ability of Inhaled Nasal Sodium Pyruvate to Affect Headaches in COVID-19 Infected Patients.
Day 13
|
2.75 units on a scale
Standard Deviation 1.71
|
1.00 units on a scale
Standard Deviation 1.00
|
|
Evaluate the Ability of Inhaled Nasal Sodium Pyruvate to Affect Headaches in COVID-19 Infected Patients.
Day 14
|
2.0 units on a scale
Standard Deviation 1.83
|
1.00 units on a scale
Standard Deviation 1.00
|
SECONDARY outcome
Timeframe: Daily from day 1-14.Population: Only patients that reported experiencing this symptom were included in the analysis.
Patients self reported the symptom in a patient log daily for 14 days. A Likert scale from 0-10 was used to rank the symptom severity, with 10 representing the most severe symptoms.
Outcome measures
| Measure |
Treatment of COVID-19 Infected Patients With a Sodium Pyruvate Nasal Spray
n=8 Participants
In this arm, patients will be provided with N115 sodium pyruvate nasal spray and instructed to use it 3x daily for 14 days. This group will be compared to the placebo control group to determine if sodium pyruvate reduces the symptoms, duration and replication of COVID-19 infections.
Sodium Pyruvate: Subjects will use a sodium pyruvate nasal spray 3x daily for 14 days.
|
Placebo Control Treatment of COVID-19 Infected Patients
n=8 Participants
In this arm, patients will be provided with a saline nasal spray as a placebo control. Patients will use the saline nasal spray 3x daily for 14 days, similar to the sodium pyruvate drug arm. This will serve as a control for the symptoms, duration and replication of COVID-19 infections.
Saline: Subjects will use a saline nasal spray 3x daily for 14 days.
|
|---|---|---|
|
Evaluate the Ability of Inhaled Nasal Sodium Pyruvate to Affect Chills in COVID-19 Infected Patients.
Day 1
|
5 units on a scale
Standard Deviation 2.67
|
3.75 units on a scale
Standard Deviation 1.67
|
|
Evaluate the Ability of Inhaled Nasal Sodium Pyruvate to Affect Chills in COVID-19 Infected Patients.
Day 2
|
5.25 units on a scale
Standard Deviation 2.55
|
3.50 units on a scale
Standard Deviation 2.07
|
|
Evaluate the Ability of Inhaled Nasal Sodium Pyruvate to Affect Chills in COVID-19 Infected Patients.
Day 3
|
5.25 units on a scale
Standard Deviation 2.05
|
3.50 units on a scale
Standard Deviation 2.07
|
|
Evaluate the Ability of Inhaled Nasal Sodium Pyruvate to Affect Chills in COVID-19 Infected Patients.
Day 4
|
4.38 units on a scale
Standard Deviation 2.33
|
3.13 units on a scale
Standard Deviation 1.96
|
|
Evaluate the Ability of Inhaled Nasal Sodium Pyruvate to Affect Chills in COVID-19 Infected Patients.
Day 5
|
4.50 units on a scale
Standard Deviation 2.33
|
2.75 units on a scale
Standard Deviation 1.91
|
|
Evaluate the Ability of Inhaled Nasal Sodium Pyruvate to Affect Chills in COVID-19 Infected Patients.
Day 6
|
4.00 units on a scale
Standard Deviation 2.00
|
2.63 units on a scale
Standard Deviation 1.69
|
|
Evaluate the Ability of Inhaled Nasal Sodium Pyruvate to Affect Chills in COVID-19 Infected Patients.
Day 7
|
4.13 units on a scale
Standard Deviation 2.17
|
2.25 units on a scale
Standard Deviation 1.28
|
|
Evaluate the Ability of Inhaled Nasal Sodium Pyruvate to Affect Chills in COVID-19 Infected Patients.
Day 8
|
4.25 units on a scale
Standard Deviation 2.12
|
1.75 units on a scale
Standard Deviation 1.49
|
|
Evaluate the Ability of Inhaled Nasal Sodium Pyruvate to Affect Chills in COVID-19 Infected Patients.
Day 9
|
3.88 units on a scale
Standard Deviation 2.03
|
1.38 units on a scale
Standard Deviation 1.30
|
|
Evaluate the Ability of Inhaled Nasal Sodium Pyruvate to Affect Chills in COVID-19 Infected Patients.
Day 10
|
3.63 units on a scale
Standard Deviation 1.92
|
1.00 units on a scale
Standard Deviation 1.07
|
|
Evaluate the Ability of Inhaled Nasal Sodium Pyruvate to Affect Chills in COVID-19 Infected Patients.
Day 11
|
3.13 units on a scale
Standard Deviation 1.81
|
0.75 units on a scale
Standard Deviation 1.04
|
|
Evaluate the Ability of Inhaled Nasal Sodium Pyruvate to Affect Chills in COVID-19 Infected Patients.
Day 12
|
2.88 units on a scale
Standard Deviation 1.89
|
0.38 units on a scale
Standard Deviation 0.52
|
|
Evaluate the Ability of Inhaled Nasal Sodium Pyruvate to Affect Chills in COVID-19 Infected Patients.
Day 13
|
2.38 units on a scale
Standard Deviation 2.13
|
0.38 units on a scale
Standard Deviation 0.52
|
|
Evaluate the Ability of Inhaled Nasal Sodium Pyruvate to Affect Chills in COVID-19 Infected Patients.
Day 14
|
2.38 units on a scale
Standard Deviation 2.13
|
0.38 units on a scale
Standard Deviation 0.52
|
SECONDARY outcome
Timeframe: Daily from day 1-14.Population: Only patients that reported experiencing this symptom were included in the analysis.
Patients self reported the symptom in a patient log daily for 14 days. A Likert scale from 0-10 was used to rank the symptom severity, with 10 representing the most severe symptoms. The symptoms of both coughing and sneezing were assessed on the same Likert scale for this Outcome Measure.
Outcome measures
| Measure |
Treatment of COVID-19 Infected Patients With a Sodium Pyruvate Nasal Spray
n=10 Participants
In this arm, patients will be provided with N115 sodium pyruvate nasal spray and instructed to use it 3x daily for 14 days. This group will be compared to the placebo control group to determine if sodium pyruvate reduces the symptoms, duration and replication of COVID-19 infections.
Sodium Pyruvate: Subjects will use a sodium pyruvate nasal spray 3x daily for 14 days.
|
Placebo Control Treatment of COVID-19 Infected Patients
n=11 Participants
In this arm, patients will be provided with a saline nasal spray as a placebo control. Patients will use the saline nasal spray 3x daily for 14 days, similar to the sodium pyruvate drug arm. This will serve as a control for the symptoms, duration and replication of COVID-19 infections.
Saline: Subjects will use a saline nasal spray 3x daily for 14 days.
|
|---|---|---|
|
Evaluate the Ability of Inhaled Nasal Sodium Pyruvate to Affect Coughing and Sneezing in COVID-19 Infected Patients.
Day 1
|
3.90 units on a scale
Standard Deviation 2.69
|
4.45 units on a scale
Standard Deviation 2.16
|
|
Evaluate the Ability of Inhaled Nasal Sodium Pyruvate to Affect Coughing and Sneezing in COVID-19 Infected Patients.
Day 2
|
3.70 units on a scale
Standard Deviation 2.58
|
4.45 units on a scale
Standard Deviation 2.16
|
|
Evaluate the Ability of Inhaled Nasal Sodium Pyruvate to Affect Coughing and Sneezing in COVID-19 Infected Patients.
Day 3
|
3.50 units on a scale
Standard Deviation 2.42
|
4.18 units on a scale
Standard Deviation 2.44
|
|
Evaluate the Ability of Inhaled Nasal Sodium Pyruvate to Affect Coughing and Sneezing in COVID-19 Infected Patients.
Day 4
|
3.40 units on a scale
Standard Deviation 1.78
|
4.18 units on a scale
Standard Deviation 2.27
|
|
Evaluate the Ability of Inhaled Nasal Sodium Pyruvate to Affect Coughing and Sneezing in COVID-19 Infected Patients.
Day 5
|
3.20 units on a scale
Standard Deviation 1.93
|
3.64 units on a scale
Standard Deviation 2.16
|
|
Evaluate the Ability of Inhaled Nasal Sodium Pyruvate to Affect Coughing and Sneezing in COVID-19 Infected Patients.
Day 6
|
3.10 units on a scale
Standard Deviation 2.02
|
3.64 units on a scale
Standard Deviation 2.25
|
|
Evaluate the Ability of Inhaled Nasal Sodium Pyruvate to Affect Coughing and Sneezing in COVID-19 Infected Patients.
Day 7
|
2.80 units on a scale
Standard Deviation 1.93
|
3.55 units on a scale
Standard Deviation 2.16
|
|
Evaluate the Ability of Inhaled Nasal Sodium Pyruvate to Affect Coughing and Sneezing in COVID-19 Infected Patients.
Day 8
|
2.70 units on a scale
Standard Deviation 2.0
|
2.82 units on a scale
Standard Deviation 2.40
|
|
Evaluate the Ability of Inhaled Nasal Sodium Pyruvate to Affect Coughing and Sneezing in COVID-19 Infected Patients.
Day 9
|
2.40 units on a scale
Standard Deviation 1.96
|
2.73 units on a scale
Standard Deviation 2.10
|
|
Evaluate the Ability of Inhaled Nasal Sodium Pyruvate to Affect Coughing and Sneezing in COVID-19 Infected Patients.
Day 10
|
190 units on a scale
Standard Deviation 1.52
|
2.36 units on a scale
Standard Deviation 2.16
|
|
Evaluate the Ability of Inhaled Nasal Sodium Pyruvate to Affect Coughing and Sneezing in COVID-19 Infected Patients.
Day 11
|
1.40 units on a scale
Standard Deviation 1.65
|
2.09 units on a scale
Standard Deviation 2.17
|
|
Evaluate the Ability of Inhaled Nasal Sodium Pyruvate to Affect Coughing and Sneezing in COVID-19 Infected Patients.
Day 12
|
1.40 units on a scale
Standard Deviation 1.65
|
1.64 units on a scale
Standard Deviation 1.69
|
|
Evaluate the Ability of Inhaled Nasal Sodium Pyruvate to Affect Coughing and Sneezing in COVID-19 Infected Patients.
Day 13
|
1.10 units on a scale
Standard Deviation 1.66
|
1.45 units on a scale
Standard Deviation 1.44
|
|
Evaluate the Ability of Inhaled Nasal Sodium Pyruvate to Affect Coughing and Sneezing in COVID-19 Infected Patients.
Day 14
|
1.10 units on a scale
Standard Deviation 1.66
|
1.18 units on a scale
Standard Deviation 1.17
|
SECONDARY outcome
Timeframe: Daily from day 1-14.Population: Only patients that reported experiencing this symptom were included in the analysis.
Patients self reported the symptom in a patient log daily for 14 days. A Likert scale from 0-10 was used to rank the symptom severity, with 10 representing the most severe symptoms.
Outcome measures
| Measure |
Treatment of COVID-19 Infected Patients With a Sodium Pyruvate Nasal Spray
n=7 Participants
In this arm, patients will be provided with N115 sodium pyruvate nasal spray and instructed to use it 3x daily for 14 days. This group will be compared to the placebo control group to determine if sodium pyruvate reduces the symptoms, duration and replication of COVID-19 infections.
Sodium Pyruvate: Subjects will use a sodium pyruvate nasal spray 3x daily for 14 days.
|
Placebo Control Treatment of COVID-19 Infected Patients
n=7 Participants
In this arm, patients will be provided with a saline nasal spray as a placebo control. Patients will use the saline nasal spray 3x daily for 14 days, similar to the sodium pyruvate drug arm. This will serve as a control for the symptoms, duration and replication of COVID-19 infections.
Saline: Subjects will use a saline nasal spray 3x daily for 14 days.
|
|---|---|---|
|
Evaluate the Ability of Inhaled Nasal Sodium Pyruvate to Affect Sore Throat in COVID-19 Infected Patients.
Day 1
|
4.71 units on a scale
Standard Deviation 2.29
|
4.71 units on a scale
Standard Deviation 1.70
|
|
Evaluate the Ability of Inhaled Nasal Sodium Pyruvate to Affect Sore Throat in COVID-19 Infected Patients.
Day 2
|
4.71 units on a scale
Standard Deviation 2.14
|
4.71 units on a scale
Standard Deviation 1.70
|
|
Evaluate the Ability of Inhaled Nasal Sodium Pyruvate to Affect Sore Throat in COVID-19 Infected Patients.
Day 3
|
4.57 units on a scale
Standard Deviation 1.81
|
4.57 units on a scale
Standard Deviation 1.72
|
|
Evaluate the Ability of Inhaled Nasal Sodium Pyruvate to Affect Sore Throat in COVID-19 Infected Patients.
Day 4
|
4.29 units on a scale
Standard Deviation 2.06
|
4.57 units on a scale
Standard Deviation 1.51
|
|
Evaluate the Ability of Inhaled Nasal Sodium Pyruvate to Affect Sore Throat in COVID-19 Infected Patients.
Day 5
|
4.14 units on a scale
Standard Deviation 2.04
|
4.0 units on a scale
Standard Deviation 1.73
|
|
Evaluate the Ability of Inhaled Nasal Sodium Pyruvate to Affect Sore Throat in COVID-19 Infected Patients.
Day 6
|
4.29 units on a scale
Standard Deviation 2.06
|
3.86 units on a scale
Standard Deviation 1.77
|
|
Evaluate the Ability of Inhaled Nasal Sodium Pyruvate to Affect Sore Throat in COVID-19 Infected Patients.
Day 7
|
4.14 units on a scale
Standard Deviation 2.12
|
3.71 units on a scale
Standard Deviation 1.60
|
|
Evaluate the Ability of Inhaled Nasal Sodium Pyruvate to Affect Sore Throat in COVID-19 Infected Patients.
Day 8
|
3.29 units on a scale
Standard Deviation 2.43
|
3.00 units on a scale
Standard Deviation 2.31
|
|
Evaluate the Ability of Inhaled Nasal Sodium Pyruvate to Affect Sore Throat in COVID-19 Infected Patients.
Day 9
|
2.86 units on a scale
Standard Deviation 2.12
|
2.86 units on a scale
Standard Deviation 2.12
|
|
Evaluate the Ability of Inhaled Nasal Sodium Pyruvate to Affect Sore Throat in COVID-19 Infected Patients.
Day 10
|
2.29 units on a scale
Standard Deviation 1.70
|
2.57 units on a scale
Standard Deviation 2.07
|
|
Evaluate the Ability of Inhaled Nasal Sodium Pyruvate to Affect Sore Throat in COVID-19 Infected Patients.
Day 11
|
2.00 units on a scale
Standard Deviation 1.91
|
2.14 units on a scale
Standard Deviation 2.27
|
|
Evaluate the Ability of Inhaled Nasal Sodium Pyruvate to Affect Sore Throat in COVID-19 Infected Patients.
Day 12
|
1.57 units on a scale
Standard Deviation 1.72
|
1.71 units on a scale
Standard Deviation 1.60
|
|
Evaluate the Ability of Inhaled Nasal Sodium Pyruvate to Affect Sore Throat in COVID-19 Infected Patients.
Day 13
|
0.86 units on a scale
Standard Deviation 1.46
|
1.57 units on a scale
Standard Deviation 1.51
|
|
Evaluate the Ability of Inhaled Nasal Sodium Pyruvate to Affect Sore Throat in COVID-19 Infected Patients.
Day 14
|
0.86 units on a scale
Standard Deviation 1.46
|
1.29 units on a scale
Standard Deviation 1.60
|
SECONDARY outcome
Timeframe: Daily from day 1-14.Population: Only patients that reported experiencing this symptom were included in the analysis.
Patients self reported the symptom in a patient log daily for 14 days. A Likert scale from 0-10 was used to rank the symptom severity, with 10 representing the most severe symptoms.
Outcome measures
| Measure |
Treatment of COVID-19 Infected Patients With a Sodium Pyruvate Nasal Spray
n=8 Participants
In this arm, patients will be provided with N115 sodium pyruvate nasal spray and instructed to use it 3x daily for 14 days. This group will be compared to the placebo control group to determine if sodium pyruvate reduces the symptoms, duration and replication of COVID-19 infections.
Sodium Pyruvate: Subjects will use a sodium pyruvate nasal spray 3x daily for 14 days.
|
Placebo Control Treatment of COVID-19 Infected Patients
n=10 Participants
In this arm, patients will be provided with a saline nasal spray as a placebo control. Patients will use the saline nasal spray 3x daily for 14 days, similar to the sodium pyruvate drug arm. This will serve as a control for the symptoms, duration and replication of COVID-19 infections.
Saline: Subjects will use a saline nasal spray 3x daily for 14 days.
|
|---|---|---|
|
Evaluate the Ability of Inhaled Nasal Sodium Pyruvate to Affect Congestions in COVID-19 Infected Patients.
Day 1
|
5.00 units on a scale
Standard Deviation 3.38
|
5.00 units on a scale
Standard Deviation 3.56
|
|
Evaluate the Ability of Inhaled Nasal Sodium Pyruvate to Affect Congestions in COVID-19 Infected Patients.
Day 2
|
5.00 units on a scale
Standard Deviation 2.83
|
5.00 units on a scale
Standard Deviation 3.62
|
|
Evaluate the Ability of Inhaled Nasal Sodium Pyruvate to Affect Congestions in COVID-19 Infected Patients.
Day 3
|
4.75 units on a scale
Standard Deviation 2.92
|
4.90 units on a scale
Standard Deviation 3.63
|
|
Evaluate the Ability of Inhaled Nasal Sodium Pyruvate to Affect Congestions in COVID-19 Infected Patients.
Day 4
|
4.50 units on a scale
Standard Deviation 2.39
|
4.60 units on a scale
Standard Deviation 2.91
|
|
Evaluate the Ability of Inhaled Nasal Sodium Pyruvate to Affect Congestions in COVID-19 Infected Patients.
Day 5
|
3.50 units on a scale
Standard Deviation 2.00
|
4.10 units on a scale
Standard Deviation 2.85
|
|
Evaluate the Ability of Inhaled Nasal Sodium Pyruvate to Affect Congestions in COVID-19 Infected Patients.
Day 6
|
3.50 units on a scale
Standard Deviation 2.00
|
4.30 units on a scale
Standard Deviation 2.98
|
|
Evaluate the Ability of Inhaled Nasal Sodium Pyruvate to Affect Congestions in COVID-19 Infected Patients.
Day 7
|
3.25 units on a scale
Standard Deviation 1.98
|
3.70 units on a scale
Standard Deviation 2.67
|
|
Evaluate the Ability of Inhaled Nasal Sodium Pyruvate to Affect Congestions in COVID-19 Infected Patients.
Day 8
|
4.31 units on a scale
Standard Deviation 2.30
|
2.80 units on a scale
Standard Deviation 2.74
|
|
Evaluate the Ability of Inhaled Nasal Sodium Pyruvate to Affect Congestions in COVID-19 Infected Patients.
Day 9
|
3.00 units on a scale
Standard Deviation 2.39
|
2.60 units on a scale
Standard Deviation 2.50
|
|
Evaluate the Ability of Inhaled Nasal Sodium Pyruvate to Affect Congestions in COVID-19 Infected Patients.
Day 10
|
2.88 units on a scale
Standard Deviation 1.73
|
2.20 units on a scale
Standard Deviation 2.74
|
|
Evaluate the Ability of Inhaled Nasal Sodium Pyruvate to Affect Congestions in COVID-19 Infected Patients.
Day 11
|
2.13 units on a scale
Standard Deviation 1.96
|
1.60 units on a scale
Standard Deviation 2.07
|
|
Evaluate the Ability of Inhaled Nasal Sodium Pyruvate to Affect Congestions in COVID-19 Infected Patients.
Day 12
|
1.50 units on a scale
Standard Deviation 1.31
|
1.50 units on a scale
Standard Deviation 2.01
|
|
Evaluate the Ability of Inhaled Nasal Sodium Pyruvate to Affect Congestions in COVID-19 Infected Patients.
Day 13
|
1.00 units on a scale
Standard Deviation 1.07
|
0.60 units on a scale
Standard Deviation 1.07
|
|
Evaluate the Ability of Inhaled Nasal Sodium Pyruvate to Affect Congestions in COVID-19 Infected Patients.
Day 14
|
1.25 units on a scale
Standard Deviation 1.28
|
0.60 units on a scale
Standard Deviation 1.07
|
SECONDARY outcome
Timeframe: Daily from day 1-14Population: Only patients that reported experiencing this symptom were included in the analysis.
Patients self reported the symptom in a patient log daily for 14 days. A Likert scale from 0-10 was used to rank the symptom severity, with 10 representing the most severe symptoms.
Outcome measures
| Measure |
Treatment of COVID-19 Infected Patients With a Sodium Pyruvate Nasal Spray
n=12 Participants
In this arm, patients will be provided with N115 sodium pyruvate nasal spray and instructed to use it 3x daily for 14 days. This group will be compared to the placebo control group to determine if sodium pyruvate reduces the symptoms, duration and replication of COVID-19 infections.
Sodium Pyruvate: Subjects will use a sodium pyruvate nasal spray 3x daily for 14 days.
|
Placebo Control Treatment of COVID-19 Infected Patients
n=11 Participants
In this arm, patients will be provided with a saline nasal spray as a placebo control. Patients will use the saline nasal spray 3x daily for 14 days, similar to the sodium pyruvate drug arm. This will serve as a control for the symptoms, duration and replication of COVID-19 infections.
Saline: Subjects will use a saline nasal spray 3x daily for 14 days.
|
|---|---|---|
|
Evaluate the Ability of Inhaled Nasal Sodium Pyruvate to Affect Trouble Breathing in COVID-19 Infected Patients.
Day 1
|
5.08 units on a scale
Standard Deviation 3.73
|
5.18 units on a scale
Standard Deviation 4.00
|
|
Evaluate the Ability of Inhaled Nasal Sodium Pyruvate to Affect Trouble Breathing in COVID-19 Infected Patients.
Day 2
|
5.25 units on a scale
Standard Deviation 3.57
|
5.18 units on a scale
Standard Deviation 4.00
|
|
Evaluate the Ability of Inhaled Nasal Sodium Pyruvate to Affect Trouble Breathing in COVID-19 Infected Patients.
Day 3
|
5.00 units on a scale
Standard Deviation 3.28
|
4.91 units on a scale
Standard Deviation 4.04
|
|
Evaluate the Ability of Inhaled Nasal Sodium Pyruvate to Affect Trouble Breathing in COVID-19 Infected Patients.
Day 4
|
4.42 units on a scale
Standard Deviation 2.71
|
4.27 units on a scale
Standard Deviation 3.47
|
|
Evaluate the Ability of Inhaled Nasal Sodium Pyruvate to Affect Trouble Breathing in COVID-19 Infected Patients.
Day 5
|
4.17 units on a scale
Standard Deviation 2.55
|
4.00 units on a scale
Standard Deviation 3.22
|
|
Evaluate the Ability of Inhaled Nasal Sodium Pyruvate to Affect Trouble Breathing in COVID-19 Infected Patients.
Day 6
|
3.75 units on a scale
Standard Deviation 2.49
|
4.18 units on a scale
Standard Deviation 2.99
|
|
Evaluate the Ability of Inhaled Nasal Sodium Pyruvate to Affect Trouble Breathing in COVID-19 Infected Patients.
Day 7
|
3.67 units on a scale
Standard Deviation 2.35
|
3.55 units on a scale
Standard Deviation 2.42
|
|
Evaluate the Ability of Inhaled Nasal Sodium Pyruvate to Affect Trouble Breathing in COVID-19 Infected Patients.
Day 8
|
3.67 units on a scale
Standard Deviation 2.35
|
3.00 units on a scale
Standard Deviation 1.90
|
|
Evaluate the Ability of Inhaled Nasal Sodium Pyruvate to Affect Trouble Breathing in COVID-19 Infected Patients.
Day 9
|
2.92 units on a scale
Standard Deviation 2.31
|
2.55 units on a scale
Standard Deviation 1.75
|
|
Evaluate the Ability of Inhaled Nasal Sodium Pyruvate to Affect Trouble Breathing in COVID-19 Infected Patients.
Day 10
|
2.58 units on a scale
Standard Deviation 1.51
|
2.00 units on a scale
Standard Deviation 1.73
|
|
Evaluate the Ability of Inhaled Nasal Sodium Pyruvate to Affect Trouble Breathing in COVID-19 Infected Patients.
Day 11
|
2.17 units on a scale
Standard Deviation 1.27
|
1.64 units on a scale
Standard Deviation 1.21
|
|
Evaluate the Ability of Inhaled Nasal Sodium Pyruvate to Affect Trouble Breathing in COVID-19 Infected Patients.
Day 12
|
1.50 units on a scale
Standard Deviation 1.24
|
0.91 units on a scale
Standard Deviation 0.83
|
|
Evaluate the Ability of Inhaled Nasal Sodium Pyruvate to Affect Trouble Breathing in COVID-19 Infected Patients.
Day 13
|
1.25 units on a scale
Standard Deviation 1.06
|
0.36 units on a scale
Standard Deviation 0.50
|
|
Evaluate the Ability of Inhaled Nasal Sodium Pyruvate to Affect Trouble Breathing in COVID-19 Infected Patients.
Day 14
|
0.92 units on a scale
Standard Deviation 1.16
|
0.27 units on a scale
Standard Deviation 0.47
|
SECONDARY outcome
Timeframe: Daily from day 1-14.Population: Only patients that reported experiencing this symptom were included in the analysis.
Patients self reported the symptom in a patient log daily for 14 days. A Likert scale from 0-10 was used to rank the symptom severity, with 10 representing the most severe symptoms.
Outcome measures
| Measure |
Treatment of COVID-19 Infected Patients With a Sodium Pyruvate Nasal Spray
n=7 Participants
In this arm, patients will be provided with N115 sodium pyruvate nasal spray and instructed to use it 3x daily for 14 days. This group will be compared to the placebo control group to determine if sodium pyruvate reduces the symptoms, duration and replication of COVID-19 infections.
Sodium Pyruvate: Subjects will use a sodium pyruvate nasal spray 3x daily for 14 days.
|
Placebo Control Treatment of COVID-19 Infected Patients
n=4 Participants
In this arm, patients will be provided with a saline nasal spray as a placebo control. Patients will use the saline nasal spray 3x daily for 14 days, similar to the sodium pyruvate drug arm. This will serve as a control for the symptoms, duration and replication of COVID-19 infections.
Saline: Subjects will use a saline nasal spray 3x daily for 14 days.
|
|---|---|---|
|
Evaluate the Ability of Inhaled Nasal Sodium Pyruvate to Affect Fatigue in COVID-19 Infected Patients.
Day 1
|
6.43 units on a scale
Standard Deviation 1.51
|
7.50 units on a scale
Standard Deviation 1.29
|
|
Evaluate the Ability of Inhaled Nasal Sodium Pyruvate to Affect Fatigue in COVID-19 Infected Patients.
Day 2
|
6.43 units on a scale
Standard Deviation 1.51
|
7.50 units on a scale
Standard Deviation 1.29
|
|
Evaluate the Ability of Inhaled Nasal Sodium Pyruvate to Affect Fatigue in COVID-19 Infected Patients.
Day 3
|
6.00 units on a scale
Standard Deviation 1.91
|
7.25 units on a scale
Standard Deviation 1.50
|
|
Evaluate the Ability of Inhaled Nasal Sodium Pyruvate to Affect Fatigue in COVID-19 Infected Patients.
Day 4
|
4.86 units on a scale
Standard Deviation 1.35
|
7.00 units on a scale
Standard Deviation 1.41
|
|
Evaluate the Ability of Inhaled Nasal Sodium Pyruvate to Affect Fatigue in COVID-19 Infected Patients.
Day 5
|
4.57 units on a scale
Standard Deviation 1.72
|
7.00 units on a scale
Standard Deviation 1.41
|
|
Evaluate the Ability of Inhaled Nasal Sodium Pyruvate to Affect Fatigue in COVID-19 Infected Patients.
Day 6
|
4.71 units on a scale
Standard Deviation 1.50
|
6.50 units on a scale
Standard Deviation 2.08
|
|
Evaluate the Ability of Inhaled Nasal Sodium Pyruvate to Affect Fatigue in COVID-19 Infected Patients.
Day 7
|
4.57 units on a scale
Standard Deviation 1.72
|
6.50 units on a scale
Standard Deviation 1.73
|
|
Evaluate the Ability of Inhaled Nasal Sodium Pyruvate to Affect Fatigue in COVID-19 Infected Patients.
Day 8
|
4.29 units on a scale
Standard Deviation 1.98
|
6.50 units on a scale
Standard Deviation 1.73
|
|
Evaluate the Ability of Inhaled Nasal Sodium Pyruvate to Affect Fatigue in COVID-19 Infected Patients.
Day 9
|
3.43 units on a scale
Standard Deviation 1.90
|
4.50 units on a scale
Standard Deviation 1.29
|
|
Evaluate the Ability of Inhaled Nasal Sodium Pyruvate to Affect Fatigue in COVID-19 Infected Patients.
Day 10
|
3.29 units on a scale
Standard Deviation 1.60
|
4.25 units on a scale
Standard Deviation 1.50
|
|
Evaluate the Ability of Inhaled Nasal Sodium Pyruvate to Affect Fatigue in COVID-19 Infected Patients.
Day 11
|
2.57 units on a scale
Standard Deviation 1.51
|
3.50 units on a scale
Standard Deviation 1.91
|
|
Evaluate the Ability of Inhaled Nasal Sodium Pyruvate to Affect Fatigue in COVID-19 Infected Patients.
Day 12
|
2.00 units on a scale
Standard Deviation 1.00
|
3.50 units on a scale
Standard Deviation 1.91
|
|
Evaluate the Ability of Inhaled Nasal Sodium Pyruvate to Affect Fatigue in COVID-19 Infected Patients.
Day 13
|
1.57 units on a scale
Standard Deviation 1.27
|
2.50 units on a scale
Standard Deviation 1.29
|
|
Evaluate the Ability of Inhaled Nasal Sodium Pyruvate to Affect Fatigue in COVID-19 Infected Patients.
Day 14
|
1.57 units on a scale
Standard Deviation 1.27
|
2.25 units on a scale
Standard Deviation 1.26
|
Adverse Events
Treatment of COVID-19 Infected Patients With a Sodium Pyruvate Nasal Spray
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo Control Treatment of COVID-19 Infected Patients
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place