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Effects of Sodium Pyruvate Nasal Spray in COVID-19 Long Haulers.

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ClinicalTrials.gov Identifier: NCT04871815
Recruitment Status : Active, not recruiting
First Posted : May 4, 2021
Results First Posted : October 7, 2021
Last Update Posted : October 7, 2021
Sponsor:
Collaborators:
Missouri State University
Dynamic DNA Labs
Trinity Health Care
Family First Medical Research Center
Information provided by (Responsible Party):
Cellular Sciences, inc.

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Long COVID
Intervention Drug: sodium pyruvate nasal spray
Enrollment 22
Recruitment Details  
Pre-assignment Details 22 patients were enrolled and served as their own baseline control for 7 days followed by 7 days of treatment.
Arm/Group Title No Treatment First Then Sodium Pyruvate Nasal Spray
Hide Arm/Group Description 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.
Period Title: Baseline Day 1-7
Started 22
Completed 22
Not Completed 0
Period Title: N115 Treatment Day 8-14
Started 22
Completed 22
Not Completed 0
Arm/Group Title Treatment of COVID19 Long Haulers With Sodium Pyruvate Nasal Spray
Hide Arm/Group Description 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.
Overall Number of Baseline Participants 22
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 22 participants
31.68  (9.25)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants
Female
11
  50.0%
Male
11
  50.0%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 22 participants
22
 100.0%
1.Primary Outcome
Title Change in the Symptoms of Long COVID-19 Patients
Hide Description 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.
Time Frame 14 days
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Long COVID-19, Treatment With 20mM Sodium Pyruvate Nasal Spray Long COVID-19, No Treatment (Baseline)
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 22 22
Mean (Standard Deviation)
Unit of Measure: units on a scale
Body Aches Number Analyzed 3 participants 3 participants
20.33  (4.933) 27  (5.568)
Headaches Number Analyzed 7 participants 7 participants
15.71  (4.030) 22.43  (5.062)
Coughing/Sneezing Number Analyzed 11 participants 11 participants
16.09  (8.043) 28.36  (11.59)
Sore Throat Number Analyzed 1 participants 1 participants
9  (0) 3  (0)
Trouble Breathing Number Analyzed 16 participants 16 participants
11.88  (7.191) 27.75  (13.05)
Congestion Number Analyzed 4 participants 4 participants
14.75  (9.032) 28.25  (19.28)
Fatigue Number Analyzed 3 participants 3 participants
20.67  (2.517) 33  (10.82)
Loss of Smell/Taste Number Analyzed 4 participants 4 participants
23.25  (31.28) 42  (26.75)
Anxiety Number Analyzed 2 participants 2 participants
24  (5.657) 28  (0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Long COVID-19, Treatment With 20mM Sodium Pyruvate Nasal Spray, Long COVID-19, No Treatment (Baseline)
Comments Body Aches
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.200
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Long COVID-19, Treatment With 20mM Sodium Pyruvate Nasal Spray, Long COVID-19, No Treatment (Baseline)
Comments Headaches
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0326
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Long COVID-19, Treatment With 20mM Sodium Pyruvate Nasal Spray, Long COVID-19, No Treatment (Baseline)
Comments Coughing/Sneezing
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0043
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Long COVID-19, Treatment With 20mM Sodium Pyruvate Nasal Spray, Long COVID-19, No Treatment (Baseline)
Comments Trouble Breathing
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0003
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Long COVID-19, Treatment With 20mM Sodium Pyruvate Nasal Spray, Long COVID-19, No Treatment (Baseline)
Comments Congestion
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3714
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Long COVID-19, Treatment With 20mM Sodium Pyruvate Nasal Spray, Long COVID-19, No Treatment (Baseline)
Comments Fatigue
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.300
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Long COVID-19, Treatment With 20mM Sodium Pyruvate Nasal Spray, Long COVID-19, No Treatment (Baseline)
Comments Loss of Smell/Taste
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2286
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Long COVID-19, Treatment With 20mM Sodium Pyruvate Nasal Spray, Long COVID-19, No Treatment (Baseline)
Comments Anxiety
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.999
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
2.Primary Outcome
Title Change in Body Temperature in Long COVID-19 Patients
Hide Description Body 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.
Time Frame 14 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title COVID19 Long Haulers, Treatment With Sodium Pyruvate Nasal Spray COVID-19 Long Haulers, No Treatment (Baseline)
Hide Arm/Group Description:
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 and continue to log their symptoms. Vital signs (Blood pressure, Pulse, and SaO2) were recorded on day 8 after the first treatment and on day 14. Body temperature continued to be recorded twice daily from day 8 to day 14.
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. Vital signs (Blood pressure, Pulse, and SaO2) were recorded on day 1 and 8 and body temperature recorded twice daily from day 1 to day 7.
Overall Number of Participants Analyzed 22 22
Mean (Standard Deviation)
Unit of Measure: Degrees Fahrenheit
98.41  (0.1076) 98.67  (0.1866)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection COVID19 Long Haulers, Treatment With Sodium Pyruvate Nasal Spray, COVID-19 Long Haulers, No Treatment (Baseline)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
3.Primary Outcome
Title Change in Pulse Rate in Long COVID-19 Patients
Hide Description Patient heart rate will be measured as beats per minute.
Time Frame Day 1 (1st day Baseline), Day 8 (8th day Baseline), Day 8 (1st day Post-treatment) and Day 14 (7th day post-treatment)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title COVID19 Long Haulers, Treatment With 20mM Sodium Pyruvate Nasal Spray COVID19 Long Haulers, No Treatment (Baseline)
Hide Arm/Group Description:
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, Pulse and SaO2) were recorded on day 8 after the first treatment and on day 14. Body temperature was recorded twice daily from day 8-14.
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.
Overall Number of Participants Analyzed 22 22
Mean (Standard Deviation)
Unit of Measure: Beats/minute
Initial reading (day 1 baseline and day 8 treatment) 80.38  (1.499) 81.10  (3.463)
Second reading (day 8 baseline and day 14 treatment) 79.90  (1.841) 81.14  (2.330)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection COVID19 Long Haulers, Treatment With 20mM Sodium Pyruvate Nasal Spray, COVID19 Long Haulers, No Treatment (Baseline)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1963
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
4.Primary Outcome
Title Change in Blood Oxygenation in Long COVID-19 Patients
Hide Description Blood oxygenation will be measured as %O2 saturation.
Time Frame Day 1 (1st day Baseline), Day 8 (8th day Baseline), Day 8 (1st day Post-treatment) and Day 14 (7th day post-treatment)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title COVID-19 Long Haulers, Treatment With Sodium Pyruvate Nasal Spray COVID-19 Long Haulers, No Treatment (Baseline)
Hide Arm/Group Description:
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 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 8 to day 14.
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.
Overall Number of Participants Analyzed 22 22
Mean (Standard Deviation)
Unit of Measure: % Blood oxygen saturation
Initial reading (day 1 baseline and day 8 treatment) 96.59  (1.098) 95.95  (0.8985)
Second reading (day 8 baseline and day 14 treatment) 97.59  (0.6661) 96.09  (0.9211)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection COVID-19 Long Haulers, Treatment With Sodium Pyruvate Nasal Spray, COVID-19 Long Haulers, No Treatment (Baseline)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection COVID-19 Long Haulers, Treatment With Sodium Pyruvate Nasal Spray, COVID-19 Long Haulers, No Treatment (Baseline)
Comments Day 1 baseline (day 1 of study) vs Day 1 treatment (day 7 of study).
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0008
Comments Tukey's Multiple comparison test (p-value is adjusted for multiple comparisons)
Method Tukey's HSD
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection COVID-19 Long Haulers, Treatment With Sodium Pyruvate Nasal Spray, COVID-19 Long Haulers, No Treatment (Baseline)
Comments Day 1 baseline (day 1 of study) vs Day 7 treatment (day 14 of study).
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Tukey's Multiple comparison test (p-value is adjusted for multiple comparisons)
Method Tukey's HSD
Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection COVID-19 Long Haulers, Treatment With Sodium Pyruvate Nasal Spray, COVID-19 Long Haulers, No Treatment (Baseline)
Comments Day 7 baseline (day 7 of study) vs Day 1 treatment (day 7 of study).
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0114
Comments Tukey's Multiple comparison test (p-value is adjusted for multiple comparisons)
Method Tukey's HSD
Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection COVID-19 Long Haulers, Treatment With Sodium Pyruvate Nasal Spray, COVID-19 Long Haulers, No Treatment (Baseline)
Comments Day7 baseline (day 7 of study) vs Day 7 treatment (day 14 of study)
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Tukey's Multiple comparison test (p-value is adjusted for multiple comparisons)
Method Tukey's HSD
Comments [Not Specified]
Time Frame 7 days
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Long COVID-19, Treatment With 20mM Sodium Pyruvate Nasal Spray Long COVID-19, No Treatment (Baseline)
Hide Arm/Group Description After recording baseline symptoms for one week (days 1-7) without any treatment, all subjects then used N115 20mM sodium pyruvate nasal spray 3x daily for an additional week (days 8-14) and continued to log their symptoms. Vital signs (Blood pressure, temperature, Pulse and SaO2) were recorded on day 7 after the first treatment and on day 14. 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 7 prior to treatment and body temperature recorded twice daily from day 1 to day 7.
All-Cause Mortality
Long COVID-19, Treatment With 20mM Sodium Pyruvate Nasal Spray Long COVID-19, No Treatment (Baseline)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/22 (0.00%)   0/22 (0.00%) 
Hide Serious Adverse Events
Long COVID-19, Treatment With 20mM Sodium Pyruvate Nasal Spray Long COVID-19, No Treatment (Baseline)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/22 (0.00%)   0/22 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Long COVID-19, Treatment With 20mM Sodium Pyruvate Nasal Spray Long COVID-19, No Treatment (Baseline)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/22 (0.00%)   0/22 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Alain Martin
Organization: Emphycorp/Cellular Sciences, inc.
Phone: 9082371561
EMail: dr.martin@erols.com
Layout table for additonal information
Responsible Party: Cellular Sciences, inc.
ClinicalTrials.gov Identifier: NCT04871815    
Other Study ID Numbers: CSI-COVID-19_009
First Submitted: April 27, 2021
First Posted: May 4, 2021
Results First Submitted: September 27, 2021
Results First Posted: October 7, 2021
Last Update Posted: October 7, 2021