Trial Outcomes & Findings for Effects of Sodium Pyruvate Nasal Spray in COVID-19 Long Haulers. (NCT NCT04871815)
NCT ID: NCT04871815
Last Updated: 2022-03-09
Results Overview
A patient log was used to measure body ache, headache, chills, coughing/sneezing, sore throat, congestion, trouble breathing and other (patient supplied). The patients used a Likert scale from 0 to 10 to assess symptoms with 10 representing the most severe symptom and zero no symptom. The score for each individual symptom was combined into one overall symptom score for the 7 days of baseline (days 1-7) and a separate score for the 7 days of treatment (days 8-14). Therefore, a maximum 7-day score was 70 and a minimum of 0 was possible.
COMPLETED
PHASE2/PHASE3
22 participants
14 days
2022-03-09
Participant Flow
22 patients were enrolled and served as their own baseline control for 7 days followed by 7 days of treatment.
Participant milestones
| Measure |
No Treatment First Then Sodium Pyruvate Nasal Spray
All subjects were provided a log for monitoring baseline symptoms associated with Long COVID and asked to record symptom severity using a Likert scale (1-10 with 10 being the most severe) for one week with no treatment. Vital signs (Blood pressure, Pulse, and SaO2) were recorded on day 1 and 7 and body temperature recorded twice daily from day 1 to day 7. After recording baseline signs and symptoms for one week without any treatment, all subjects then used N115 20mM sodium pyruvate nasal spray 3x daily for an additional week (day 7-14) and continue to log their symptoms. Vital signs (Blood pressure, Pulse, and SaO2) were recorded on day 7 after the first treatment and on day 14. Body temperature continued to be recorded twice daily from day 7 to day 14.
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|---|---|
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Baseline Day 1-7
STARTED
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22
|
|
Baseline Day 1-7
COMPLETED
|
22
|
|
Baseline Day 1-7
NOT COMPLETED
|
0
|
|
N115 Treatment Day 8-14
STARTED
|
22
|
|
N115 Treatment Day 8-14
COMPLETED
|
22
|
|
N115 Treatment Day 8-14
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Treatment of COVID19 Long Haulers With Sodium Pyruvate Nasal Spray
n=22 Participants
This is a single arm, two phased, open label study. All subjects will be provided a log for monitoring baseline symptoms associated with Long COVID and asked to record symptom severity using a Likert scale for one week with no treatment. Vital signs (Blood pressure, temperature, Pulse and SaO2) will be recorded on day 1 and 7. After recording baseline symptoms for one week without any treatment, all subjects will then use N115 20mM sodium pyruvate nasal spray 3x daily for an additional week and continue to log their symptoms. Vital signs (Blood pressure, temperature, Pulse and SaO2) will be recorded on day 7 after the first treatment and on day 14.
|
|---|---|
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Age, Continuous
|
31.68 years
STANDARD_DEVIATION 9.25 • n=22 Participants
|
|
Sex: Female, Male
Female
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11 Participants
n=22 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=22 Participants
|
|
Region of Enrollment
United States
|
22 Participants
n=22 Participants
|
PRIMARY outcome
Timeframe: 14 daysPopulation: Patient scores for baseline days 1-7 of the study when the patients received no treatment were summed into one baseline score (range 0-70). Patient scores for day 8-14 of the study when the patients received 3x daily treatment with 20mM sodium pyruvate were summed into a second score (range 0-70). A Mann-Whitney test was then used to assess statistical difference between baseline and treatment.
A patient log was used to measure body ache, headache, chills, coughing/sneezing, sore throat, congestion, trouble breathing and other (patient supplied). The patients used a Likert scale from 0 to 10 to assess symptoms with 10 representing the most severe symptom and zero no symptom. The score for each individual symptom was combined into one overall symptom score for the 7 days of baseline (days 1-7) and a separate score for the 7 days of treatment (days 8-14). Therefore, a maximum 7-day score was 70 and a minimum of 0 was possible.
Outcome measures
| Measure |
Long COVID-19, Treatment With 20mM Sodium Pyruvate Nasal Spray
n=22 Participants
After recording baseline symptoms for one week (days 1-7) without any treatment, all subjects will then use N115 20mM sodium pyruvate nasal spray 3x daily for an additional week (days 8-14) and continue to log their symptoms. Vital signs (Blood pressure, temperature, Pulse and SaO2) were recorded on day 8 after the first treatment and on day 14.
|
Long COVID-19, No Treatment (Baseline)
n=22 Participants
All subjects were provided a log for monitoring baseline symptoms associated with Long COVID and asked to record symptom severity using a Likert scale (0-10 with 10 being the most severe) for one week with no treatment (day 1-7). Vital signs (Blood pressure, Pulse, and SaO2) were recorded on day 1 and day 8 prior to treatment and body temperature recorded twice daily from day 1 to day 7.
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|---|---|---|
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Change in the Symptoms of Long COVID-19 Patients
Body Aches
|
20.33 units on a scale
Standard Deviation 4.933
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27 units on a scale
Standard Deviation 5.568
|
|
Change in the Symptoms of Long COVID-19 Patients
Headaches
|
15.71 units on a scale
Standard Deviation 4.030
|
22.43 units on a scale
Standard Deviation 5.062
|
|
Change in the Symptoms of Long COVID-19 Patients
Coughing/Sneezing
|
16.09 units on a scale
Standard Deviation 8.043
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28.36 units on a scale
Standard Deviation 11.59
|
|
Change in the Symptoms of Long COVID-19 Patients
Sore Throat
|
9 units on a scale
Standard Deviation 0
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3 units on a scale
Standard Deviation 0
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|
Change in the Symptoms of Long COVID-19 Patients
Trouble Breathing
|
11.88 units on a scale
Standard Deviation 7.191
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27.75 units on a scale
Standard Deviation 13.05
|
|
Change in the Symptoms of Long COVID-19 Patients
Congestion
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14.75 units on a scale
Standard Deviation 9.032
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28.25 units on a scale
Standard Deviation 19.28
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|
Change in the Symptoms of Long COVID-19 Patients
Fatigue
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20.67 units on a scale
Standard Deviation 2.517
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33 units on a scale
Standard Deviation 10.82
|
|
Change in the Symptoms of Long COVID-19 Patients
Loss of Smell/Taste
|
23.25 units on a scale
Standard Deviation 31.28
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42 units on a scale
Standard Deviation 26.75
|
|
Change in the Symptoms of Long COVID-19 Patients
Anxiety
|
24 units on a scale
Standard Deviation 5.657
|
28 units on a scale
Standard Deviation 0
|
PRIMARY outcome
Timeframe: 14 daysBody temperature will be measured twice daily by thermometer in degrees Fahrenheit. Average body temperature for the first 7 days (days 1-7) was used as a baseline with no treatment and was compared to the average body temperature for the next 7 days (days 8-14) with 20mM sodium pyruvate treatment.
Outcome measures
| Measure |
Long COVID-19, Treatment With 20mM Sodium Pyruvate Nasal Spray
n=22 Participants
After recording baseline symptoms for one week (days 1-7) without any treatment, all subjects will then use N115 20mM sodium pyruvate nasal spray 3x daily for an additional week (days 8-14) and continue to log their symptoms. Vital signs (Blood pressure, temperature, Pulse and SaO2) were recorded on day 8 after the first treatment and on day 14.
|
Long COVID-19, No Treatment (Baseline)
n=22 Participants
All subjects were provided a log for monitoring baseline symptoms associated with Long COVID and asked to record symptom severity using a Likert scale (0-10 with 10 being the most severe) for one week with no treatment (day 1-7). Vital signs (Blood pressure, Pulse, and SaO2) were recorded on day 1 and day 8 prior to treatment and body temperature recorded twice daily from day 1 to day 7.
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|---|---|---|
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Change in Body Temperature in Long COVID-19 Patients
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98.41 Degrees Fahrenheit
Standard Deviation 0.1076
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98.67 Degrees Fahrenheit
Standard Deviation 0.1866
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PRIMARY outcome
Timeframe: Day 1 (1st day Baseline), Day 8 (8th day Baseline), Day 8 (1st day Post-treatment) and Day 14 (7th day post-treatment)Patient heart rate will be measured as beats per minute.
Outcome measures
| Measure |
Long COVID-19, Treatment With 20mM Sodium Pyruvate Nasal Spray
n=22 Participants
After recording baseline symptoms for one week (days 1-7) without any treatment, all subjects will then use N115 20mM sodium pyruvate nasal spray 3x daily for an additional week (days 8-14) and continue to log their symptoms. Vital signs (Blood pressure, temperature, Pulse and SaO2) were recorded on day 8 after the first treatment and on day 14.
|
Long COVID-19, No Treatment (Baseline)
n=22 Participants
All subjects were provided a log for monitoring baseline symptoms associated with Long COVID and asked to record symptom severity using a Likert scale (0-10 with 10 being the most severe) for one week with no treatment (day 1-7). Vital signs (Blood pressure, Pulse, and SaO2) were recorded on day 1 and day 8 prior to treatment and body temperature recorded twice daily from day 1 to day 7.
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|---|---|---|
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Change in Pulse Rate in Long COVID-19 Patients
Initial reading (day 1 baseline and day 8 treatment)
|
80.38 Beats/minute
Standard Deviation 1.499
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81.10 Beats/minute
Standard Deviation 3.463
|
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Change in Pulse Rate in Long COVID-19 Patients
Second reading (day 8 baseline and day 14 treatment)
|
79.90 Beats/minute
Standard Deviation 1.841
|
81.14 Beats/minute
Standard Deviation 2.330
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PRIMARY outcome
Timeframe: Day 1 (1st day Baseline), Day 8 (8th day Baseline), Day 8 (1st day Post-treatment) and Day 14 (7th day post-treatment)Blood oxygenation will be measured as %O2 saturation.
Outcome measures
| Measure |
Long COVID-19, Treatment With 20mM Sodium Pyruvate Nasal Spray
n=22 Participants
After recording baseline symptoms for one week (days 1-7) without any treatment, all subjects will then use N115 20mM sodium pyruvate nasal spray 3x daily for an additional week (days 8-14) and continue to log their symptoms. Vital signs (Blood pressure, temperature, Pulse and SaO2) were recorded on day 8 after the first treatment and on day 14.
|
Long COVID-19, No Treatment (Baseline)
n=22 Participants
All subjects were provided a log for monitoring baseline symptoms associated with Long COVID and asked to record symptom severity using a Likert scale (0-10 with 10 being the most severe) for one week with no treatment (day 1-7). Vital signs (Blood pressure, Pulse, and SaO2) were recorded on day 1 and day 8 prior to treatment and body temperature recorded twice daily from day 1 to day 7.
|
|---|---|---|
|
Change in Blood Oxygenation in Long COVID-19 Patients
Initial reading (day 1 baseline and day 8 treatment)
|
96.59 % Blood oxygen saturation
Standard Deviation 1.098
|
95.95 % Blood oxygen saturation
Standard Deviation 0.8985
|
|
Change in Blood Oxygenation in Long COVID-19 Patients
Second reading (day 8 baseline and day 14 treatment)
|
97.59 % Blood oxygen saturation
Standard Deviation 0.6661
|
96.09 % Blood oxygen saturation
Standard Deviation 0.9211
|
Adverse Events
Long COVID-19, Treatment With 20mM Sodium Pyruvate Nasal Spray
Long COVID-19, No Treatment (Baseline)
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