Trial Outcomes & Findings for Antiseptic Mouthwash / Pre-Procedural Rinse on SARS-CoV-2 Load (COVID-19) (NCT NCT04409873)
NCT ID: NCT04409873
Last Updated: 2023-11-18
Results Overview
The change in the outcome measure, SARS-CoV-2 viral load, in saliva wash RT-PCR was measured by Cycle Threshold (Ct) value. Ct value refers to the number of cycles it takes for the fluorescent signal generated during the PCR reaction to cross a certain threshold, indicating the presence of the target nucleic acid sequence, here, SARS-CoV-2. The lower the Ct value, the faster the threshold is crossed and the higher the viral load in a biological sample, suggesting a higher concentration of the SARS-CoV-2 virus in that sample.
TERMINATED
PHASE2
54 participants
Baseline to 4 weeks
2023-11-18
Participant Flow
In the initial recruitment phase, 54 participants signed the consent form and were assigned to one of five study groups. However, only 49 participants completed the entire 4-week study period.
Participant milestones
| Measure |
Control (Distilled Water)
Over the counter: Distilled water
Distilled water: Rinse and gargle 4 times daily, for 60 seconds, for 4 weeks.
|
Oral-B Mouth Sore (H2O2) Mouthwash
Over the counter: Oral-B Mouth Sore (Oral-B, USA) contains hydrogen peroxide (H2O2)
Oral-B Mouth Sore mouthwash: Rinse and gargle 4 times daily, for 60 seconds, for 4 weeks.
|
Crest Pro-Health Multi-Protection (C21H38ClN) Mouthwash
Over the counter: Crest Pro-Health Multi-Protection (Crest, USA) contains cetylpyridinium chloride (C21H38ClN)
Crest Pro-Health Multi-Protection mouthwash: Rinse and gargle 4 times daily, for 60 seconds, for 4 weeks.
|
CloSYS (ClO2) Mouthwash
Over the counter: CloSYS Ultra Sensitive Rinse (Rowpar Pharmaceutical Inc., USA) contains stabilized chlorine dioxide (ClO2)
CloSYS Ultra Sensitive Rinse mouthwash: Rinse and gargle 4 times daily, for 45 seconds, for 4 weeks.
|
Listerine Mouthwash
Over the counter: Listerine Zero (Alcohol-Free)(Johnson and Johnson, USA) (C30H52O3)
Listerine Zero Mouthwash Product: Rinse and gargle 4 times daily, for 30 seconds, for 4 weeks.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
12
|
11
|
12
|
12
|
7
|
|
Overall Study
COMPLETED
|
12
|
8
|
11
|
12
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
3
|
1
|
0
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Antiseptic Mouthwash / Pre-Procedural Rinse on SARS-CoV-2 Load (COVID-19)
Baseline characteristics by cohort
| Measure |
Control (Distilled Water)
n=12 Participants
Over the counter: Distilled water
Distilled water: Rinse and gargle 4 times daily, for 60 seconds, for 4 weeks.
|
Oral-B Mouth Sore (H2O2) Mouthwash
n=11 Participants
Over the counter: Oral-B Mouth Sore (Oral-B, USA) contains hydrogen peroxide (H2O2)
Oral-B Mouth Sore mouthwash: Rinse and gargle 4 times daily, for 60 seconds, for 4 weeks.
|
Crest Pro-Health Multi-Protection (C21H38ClN) Mouthwash
n=12 Participants
Over the counter: Crest Pro-Health Multi-Protection (Crest, USA) contains cetylpyridinium chloride (C21H38ClN)
Crest Pro-Health Multi-Protection mouthwash: Rinse and gargle 4 times daily, for 60 seconds, for 4 weeks.
|
CloSYS (ClO2) Mouthwash
n=12 Participants
Over the counter: CloSYS Ultra Sensitive Rinse (Rowpar Pharmaceutical Inc., USA) contains stabilized chlorine dioxide (ClO2)
CloSYS Ultra Sensitive Rinse mouthwash: Rinse and gargle 4 times daily, for 45 seconds, for 4 weeks.
|
Listerine Mouthwash
n=7 Participants
Over the counter: Listerine Zero (Alcohol-Free)(Johnson and Johnson, USA) (C30H52O3)
Listerine Zero Mouthwash Product: Rinse and gargle 4 times daily, for 30 seconds, for 4 weeks.
|
Total
n=54 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
1 Participants
n=30 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
11 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
9 Participants
n=7 Participants
|
7 Participants
n=31 Participants
|
48 Participants
n=30 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
5 Participants
n=30 Participants
|
|
Age, Continuous
|
38.0 Year
STANDARD_DEVIATION 11.48 • n=99 Participants
|
31.7 Year
STANDARD_DEVIATION 8.65 • n=107 Participants
|
45.6 Year
STANDARD_DEVIATION 11.77 • n=206 Participants
|
45.3 Year
STANDARD_DEVIATION 17.30 • n=7 Participants
|
37.3 Year
STANDARD_DEVIATION 12.54 • n=31 Participants
|
39.9 Year
STANDARD_DEVIATION 13.40 • n=30 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
4 Participants
n=31 Participants
|
31 Participants
n=30 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
3 Participants
n=31 Participants
|
23 Participants
n=30 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=31 Participants
|
12 Participants
n=30 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
11 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
9 Participants
n=7 Participants
|
4 Participants
n=31 Participants
|
41 Participants
n=30 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
1 Participants
n=30 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
9 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
1 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
3 Participants
n=30 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
5 Participants
n=31 Participants
|
28 Participants
n=30 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
4 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
9 Participants
n=30 Participants
|
|
Region of Enrollment
United States
|
12 participants
n=99 Participants
|
11 participants
n=107 Participants
|
12 participants
n=206 Participants
|
12 participants
n=7 Participants
|
7 participants
n=31 Participants
|
54 participants
n=30 Participants
|
PRIMARY outcome
Timeframe: Baseline to 4 weeksThe change in the outcome measure, SARS-CoV-2 viral load, in saliva wash RT-PCR was measured by Cycle Threshold (Ct) value. Ct value refers to the number of cycles it takes for the fluorescent signal generated during the PCR reaction to cross a certain threshold, indicating the presence of the target nucleic acid sequence, here, SARS-CoV-2. The lower the Ct value, the faster the threshold is crossed and the higher the viral load in a biological sample, suggesting a higher concentration of the SARS-CoV-2 virus in that sample.
Outcome measures
| Measure |
Control (Distilled Water)
n=12 Participants
Over the counter: Distilled water
Distilled water: Rinse and gargle 4 times daily, for 60 seconds, for 4 weeks.
|
Oral-B Mouth Sore (H2O2) Mouthwash
n=8 Participants
Over the counter: Oral-B Mouth Sore (Oral-B, USA) contains hydrogen peroxide (H2O2)
Oral-B Mouth Sore mouthwash: Rinse and gargle 4 times daily, for 60 seconds, for 4 weeks.
|
Crest Pro-Health Multi-Protection (C21H38ClN) Mouthwash
n=11 Participants
Over the counter: Crest Pro-Health Multi-Protection (Crest, USA) contains cetylpyridinium chloride (C21H38ClN)
Crest Pro-Health Multi-Protection mouthwash: Rinse and gargle 4 times daily, for 60 seconds, for 4 weeks.
|
CloSYS (ClO2) Mouthwash
n=12 Participants
Over the counter: CloSYS Ultra Sensitive Rinse (Rowpar Pharmaceutical Inc., USA) contains stabilized chlorine dioxide (ClO2)
CloSYS Ultra Sensitive Rinse mouthwash: Rinse and gargle 4 times daily, for 45 seconds, for 4 weeks.
|
Listerine Mouthwash
n=6 Participants
Over the counter: Listerine Zero (Alcohol-Free)(Johnson and Johnson, USA) (C30H52O3)
Listerine Zero Mouthwash Product: Rinse and gargle 4 times daily, for 30 seconds, for 4 weeks.
|
|---|---|---|---|---|---|
|
Change in SARS-CoV-2 Viral Load
|
-0.6 Absolute Change in Cycle Threshold
Standard Deviation 1.9
|
-0.4 Absolute Change in Cycle Threshold
Standard Deviation 1.5
|
0.8 Absolute Change in Cycle Threshold
Standard Deviation 1.4
|
-0.4 Absolute Change in Cycle Threshold
Standard Deviation 2.0
|
-1.4 Absolute Change in Cycle Threshold
Standard Deviation 0.8
|
SECONDARY outcome
Timeframe: Baseline to 3 monthsPopulation: The denominator is the number of participants who responded to the 3 month follow-up.
Any self-reported (questionnaire) clinical symptom(s). A symptom checklist included cough, runny nose, scratchy/sore throat, fever, chills, fatigue, muscle ache, shortness of breath, diarrhea/nausea/vomiting, loss of taste/smell, and red /painful eye. (Clinical symptoms were collected at baseline and at 3 months; only problems with the study mouth rinse were collected daily through 4 weeks.)
Outcome measures
| Measure |
Control (Distilled Water)
n=6 Participants
Over the counter: Distilled water
Distilled water: Rinse and gargle 4 times daily, for 60 seconds, for 4 weeks.
|
Oral-B Mouth Sore (H2O2) Mouthwash
n=6 Participants
Over the counter: Oral-B Mouth Sore (Oral-B, USA) contains hydrogen peroxide (H2O2)
Oral-B Mouth Sore mouthwash: Rinse and gargle 4 times daily, for 60 seconds, for 4 weeks.
|
Crest Pro-Health Multi-Protection (C21H38ClN) Mouthwash
n=3 Participants
Over the counter: Crest Pro-Health Multi-Protection (Crest, USA) contains cetylpyridinium chloride (C21H38ClN)
Crest Pro-Health Multi-Protection mouthwash: Rinse and gargle 4 times daily, for 60 seconds, for 4 weeks.
|
CloSYS (ClO2) Mouthwash
n=9 Participants
Over the counter: CloSYS Ultra Sensitive Rinse (Rowpar Pharmaceutical Inc., USA) contains stabilized chlorine dioxide (ClO2)
CloSYS Ultra Sensitive Rinse mouthwash: Rinse and gargle 4 times daily, for 45 seconds, for 4 weeks.
|
Listerine Mouthwash
n=3 Participants
Over the counter: Listerine Zero (Alcohol-Free)(Johnson and Johnson, USA) (C30H52O3)
Listerine Zero Mouthwash Product: Rinse and gargle 4 times daily, for 30 seconds, for 4 weeks.
|
|---|---|---|---|---|---|
|
Self-reported Clinical Symptom(s)
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline to 4 weeksPopulation: The denominator is the number of participants who reported adverse events, unanticipated problems, or were not lost-to-follow-up before Week 4 as per final study disposition form.
Any hospitalization(s) from baseline to 4 weeks. Hospitalization(s) were collected on adverse event, unanticipated problem, and final disposition forms.
Outcome measures
| Measure |
Control (Distilled Water)
n=12 Participants
Over the counter: Distilled water
Distilled water: Rinse and gargle 4 times daily, for 60 seconds, for 4 weeks.
|
Oral-B Mouth Sore (H2O2) Mouthwash
n=8 Participants
Over the counter: Oral-B Mouth Sore (Oral-B, USA) contains hydrogen peroxide (H2O2)
Oral-B Mouth Sore mouthwash: Rinse and gargle 4 times daily, for 60 seconds, for 4 weeks.
|
Crest Pro-Health Multi-Protection (C21H38ClN) Mouthwash
n=11 Participants
Over the counter: Crest Pro-Health Multi-Protection (Crest, USA) contains cetylpyridinium chloride (C21H38ClN)
Crest Pro-Health Multi-Protection mouthwash: Rinse and gargle 4 times daily, for 60 seconds, for 4 weeks.
|
CloSYS (ClO2) Mouthwash
n=12 Participants
Over the counter: CloSYS Ultra Sensitive Rinse (Rowpar Pharmaceutical Inc., USA) contains stabilized chlorine dioxide (ClO2)
CloSYS Ultra Sensitive Rinse mouthwash: Rinse and gargle 4 times daily, for 45 seconds, for 4 weeks.
|
Listerine Mouthwash
n=6 Participants
Over the counter: Listerine Zero (Alcohol-Free)(Johnson and Johnson, USA) (C30H52O3)
Listerine Zero Mouthwash Product: Rinse and gargle 4 times daily, for 30 seconds, for 4 weeks.
|
|---|---|---|---|---|---|
|
Any Hospitalization(s)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to 4 weeksPopulation: This study stopped enrollment early. The funder decided not to continue funding causing enrollment to cease and curtailing originally planned analyses. Participants with any samples collected after the baseline pre-rinse samples were included in the analysis population.
Change in saliva wash RT-PCR SARS-Cov-2 viral load in tobacco users, marijuana smokers, or vapers
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to 3 monthsPopulation: This study stopped enrollment early. The funder decided not to continue funding causing enrollment to cease and curtailing originally planned analyses. Participants with any samples collected after the baseline pre-rinse samples were included in the analysis population.
Change in self-reported (questionnaire) clinical symptom onset in tobacco users, marijuana smokers, or vapers. A symptom checklist will include: cough, runny nose, scratchy/sore throat, fever, chills, fatigue, muscle ache, shortness of breath, diarrhea/nausea/vomiting, loss of taste/smell, and red /painful eye.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to 4 weeksPopulation: This study stopped enrollment early. The funder decided not to continue funding causing enrollment to cease and curtailing originally planned analyses. Participants with any samples collected after the baseline pre-rinse samples were included in the analysis population.
Any hospitalization(s) in tobacco users, marijuana smokers, or vapers during the study period
Outcome measures
Outcome data not reported
Adverse Events
Control (Distilled Water)
Oral-B Mouth Sore (H2O2) Mouthwash
Crest Pro-Health Multi-Protection (C21H38ClN) Mouthwash
CloSYS (ClO2) Mouthwash
Listerine Mouthwash
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Control (Distilled Water)
n=12 participants at risk
Over the counter: Distilled water
|
Oral-B Mouth Sore (H2O2) Mouthwash
n=11 participants at risk
Over the counter: Oral-B Mouth Sore (Oral-B, USA) contains hydrogen peroxide (H2O2)
|
Crest Pro-Health Multi-Protection (C21H38ClN) Mouthwash
n=12 participants at risk
Over the counter: Crest Pro-Health Multi-Protection (Crest, USA) contains cetylpyridinium chloride (C21H38ClN)
|
CloSYS (ClO2) Mouthwash
n=12 participants at risk
Over the counter: CloSYS Ultra Sensitive Rinse (Rowpar Pharmaceutical Inc., USA) contains stabilized chlorine dioxide (ClO2)
|
Listerine Mouthwash
n=7 participants at risk
Over the counter: Listerine Zero (Alcohol-Free)(Johnson and Johnson, USA) (C30H52O3)
|
|---|---|---|---|---|---|
|
Product Issues
unanticipated event
|
0.00%
0/12 • Adverse event data were collected from baseline up to 12 months.
All-Cause Mortality or Serious Adverse Event
|
0.00%
0/11 • Adverse event data were collected from baseline up to 12 months.
All-Cause Mortality or Serious Adverse Event
|
0.00%
0/12 • Adverse event data were collected from baseline up to 12 months.
All-Cause Mortality or Serious Adverse Event
|
0.00%
0/12 • Adverse event data were collected from baseline up to 12 months.
All-Cause Mortality or Serious Adverse Event
|
14.3%
1/7 • Number of events 1 • Adverse event data were collected from baseline up to 12 months.
All-Cause Mortality or Serious Adverse Event
|
Additional Information
Dr. Stuart A. Gansky and Dr. Sepideh Banava
University of California San Francisco
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place