Trial Outcomes & Findings for Efficacy of Oral Rinses for Inactivation of COVID-19 (MOR2) (NCT NCT05178173)
NCT ID: NCT05178173
Last Updated: 2024-09-19
Results Overview
Determination of qPCR of inactivity of SARS-CoV-2 cellular infectivity in COVID-19 positive patient saliva
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
230 participants
Primary outcome timeframe
Baseline, 30 minutes
Results posted on
2024-09-19
Participant Flow
Participant milestones
| Measure |
Sterile Water
Subject participants will rinse mouth one time for 60 seconds with 20 mL of sterile water.
Placebo Comparator: Sterile Water: Sterile Water Placebo Comparator
|
27% Ethanol Plus Essential Oils
Subject participants will rinse mouth one time for 60 seconds with 20 mL 27% ethanol plus essential oils.
27% Ethanol plus essential oils: Over-the-counter antiseptic mouth rinse
|
0.075% Cetylpyridinium Chloride
Subject participants will rinse mouth one time for 60 seconds with 20 mL 0.075% Cetylpyridinium Chloride.
0.075% Cetylpyridinium Chloride: Over-the-counter antiseptic mouth rinse
|
|---|---|---|---|
|
Overall Study
STARTED
|
72
|
77
|
81
|
|
Overall Study
qPCR Performed
|
62
|
67
|
68
|
|
Overall Study
qPCR Analysis Population
|
48
|
46
|
52
|
|
Overall Study
COMPLETED
|
72
|
77
|
79
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Efficacy of Oral Rinses for Inactivation of COVID-19 (MOR2)
Baseline characteristics by cohort
| Measure |
Sterile Water
n=72 Participants
Subject participants will rinse mouth one time for 60 seconds with 20 mL of sterile water.
Placebo Comparator: Sterile Water: Sterile Water Placebo Comparator
|
27% Ethanol Plus Essential Oils
n=77 Participants
Subject participants will rinse mouth one time for 60 seconds with 20 mL 27% ethanol plus essential oils.
27% Ethanol plus essential oils: Over-the-counter antiseptic mouth rinse
|
0.075% Cetylpyridinium Chloride
n=79 Participants
Subject participants will rinse mouth one time for 60 seconds with 20 mL 0.075% Cetylpyridinium Chloride.
0.075% Cetylpyridinium Chloride: Over-the-counter antiseptic mouth rinse
|
Total
n=228 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
6 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
66 Participants
n=5 Participants
|
74 Participants
n=7 Participants
|
78 Participants
n=5 Participants
|
218 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
52 Participants
n=5 Participants
|
54 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
161 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
67 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
10 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
29 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
62 Participants
n=5 Participants
|
69 Participants
n=7 Participants
|
68 Participants
n=5 Participants
|
199 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
14 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
44 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
51 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
159 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
72 Participants
n=5 Participants
|
77 Participants
n=7 Participants
|
79 Participants
n=5 Participants
|
228 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline, 30 minutesPopulation: qPCR was not performed for those participant samples with inadequate volume. qPCR was initially performed for 62 Sterile Water, 67 27% Ethanol plus essential oils, and 68 0.075% Cetylpyridinium Chloride participants; however 14, 21, and 16 samples, respectively by arm, were below the limit of detection. Thus, these samples were excluded from the final analysis.
Determination of qPCR of inactivity of SARS-CoV-2 cellular infectivity in COVID-19 positive patient saliva
Outcome measures
| Measure |
Sterile Water
n=48 Participants
Subject participants will rinse mouth one time for 60 seconds with 20 mL of sterile water.
Placebo Comparator: Sterile Water: Sterile Water Placebo Comparator
|
27% Ethanol Plus Essential Oils
n=46 Participants
Subject participants will rinse mouth one time for 60 seconds with 20 mL 27% ethanol plus essential oils.
27% Ethanol plus essential oils: Over-the-counter antiseptic mouth rinse
|
0.075% Cetylpyridinium Chloride
n=52 Participants
Subject participants will rinse mouth one time for 60 seconds with 20 mL 0.075% Cetylpyridinium Chloride.
0.075% Cetylpyridinium Chloride: Over-the-counter antiseptic mouth rinse
|
|---|---|---|---|
|
Change in Quantitative Polymerase Chain Reaction (qPCR) From Baseline to 30 Minutes
SARS CoV-2 N1
|
0.0345 natural log copies/20μL sample
Standard Deviation 2.67
|
-0.5577 natural log copies/20μL sample
Standard Deviation 3.55
|
-1.4789 natural log copies/20μL sample
Standard Deviation 4.30
|
|
Change in Quantitative Polymerase Chain Reaction (qPCR) From Baseline to 30 Minutes
SARS CoV-2 N2
|
0.2339 natural log copies/20μL sample
Standard Deviation 2.49
|
0.1822 natural log copies/20μL sample
Standard Deviation 3.05
|
-1.3367 natural log copies/20μL sample
Standard Deviation 3.79
|
Adverse Events
Sterile Water
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
27% Ethanol Plus Essential Oils
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
0.075% Cetylpyridinium Chloride
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
Laura Jacox, DMD, PhD
University of North Carolina at Chapel Hill
Phone: 919-966-9731
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place