Trial Outcomes & Findings for Mouth Rinses for Inactivation of COVID-19 (NCT NCT04584684)

NCT ID: NCT04584684

Last Updated: 2024-03-25

Results Overview

Determination of SARS-CoV-2 viral RNA in COVID+ patient saliva using Quantitative Polymerase Chain Reaction (qPCR).

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

128 participants

Primary outcome timeframe

Baseline, 30 minutes

Results posted on

2024-03-25

Participant Flow

One participant who signed informed consent was unable to provide an adequate amount of saliva at Baseline and subsequently withdrew from the study.

Participant milestones

Participant milestones
Measure	0.9% w/v NaCl Subject participants will rinse mouth one time for 60 seconds with 10 mL of 0.9% w/v NaCl. 0.9% w/v NaCl: Saline placebo rinse	27% Ethanol Plus Essential Oils Subject participants will rinse mouth one time for 60 seconds with 10 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 10 mL 0.075% Cetylpyridinium Chloride. 0.075% Cetylpyridinium Chloride: Over-the-counter antiseptic mouth rinse	1.5% w/v Hydrogen Peroxide Subject participants will rinse mouth one time for 60 seconds with 10 mL of 1.5% w/v hydrogen peroxide rinse. 1.5% w/v Hydrogen Peroxide: Over-the-counter antiseptic mouth rinse	0.5% w/v Povidone-iodide Subject participants will rinse mouth one time for 60 seconds with 10 mL .5% w/v povidone-iodide. 0.5% w/v Povidone-iodide: Over-the-counter antiseptic mouth rinse	0.12% Chlorhexidine Gluconate Subject participants will rinse mouth one time for 60 seconds with 10 mL of 0.12% Chlorhexidine Gluconate. 0.12% Chlorohexidine Gluconate: Dentist prescribed antimicrobial mouth rinse
Overall Study STARTED	21	27	22	19	20	19
Overall Study COMPLETED	21	27	22	19	19	19
Overall Study NOT COMPLETED	0	0	0	0	1	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Mouth Rinses for Inactivation of COVID-19

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	0.9% w/v NaCl n=21 Participants Subject participants will rinse mouth one time for 60 seconds with 10 mL of 0.9% w/v NaCl. 0.9% w/v NaCl: Saline placebo rinse	27% Ethanol Plus Essential Oils n=27 Participants Subject participants will rinse mouth one time for 60 seconds with 10 mL 27% ethanol plus essential oils. 27% Ethanol plus essential oils: Over-the-counter antiseptic mouth rinse	0.075% Cetylpyridinium Chloride n=22 Participants Subject participants will rinse mouth one time for 60 seconds with 10 mL 0.075% Cetylpyridinium Chloride. 0.075% Cetylpyridinium Chloride: Over-the-counter antiseptic mouth rinse	1.5% w/v Hydrogen Peroxide n=19 Participants Subject participants will rinse mouth one time for 60 seconds with 10 mL of 1.5% w/v hydrogen peroxide rinse. 1.5% w/v Hydrogen Peroxide: Over-the-counter antiseptic mouth rinse	0.5% w/v Povidone-iodide n=20 Participants Subject participants will rinse mouth one time for 60 seconds with 10 mL .5% w/v povidone-iodide. 0.5% w/v Povidone-iodide: Over-the-counter antiseptic mouth rinse	0.12% Chlorhexidine Gluconate n=19 Participants Subject participants will rinse mouth one time for 60 seconds with 10 mL of 0.12% Chlorhexidine Gluconate. 0.12% Chlorohexidine Gluconate: Dentist prescribed antimicrobial mouth rinse	Total n=128 Participants Total of all reporting groups
Age, Categorical <=18 years	2 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	3 Participants n=115 Participants
Age, Categorical Between 18 and 65 years	19 Participants n=5 Participants	27 Participants n=7 Participants	20 Participants n=5 Participants	19 Participants n=4 Participants	20 Participants n=21 Participants	19 Participants n=10 Participants	124 Participants n=115 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	1 Participants n=115 Participants
Sex: Female, Male Female	12 Participants n=5 Participants	18 Participants n=7 Participants	13 Participants n=5 Participants	10 Participants n=4 Participants	11 Participants n=21 Participants	10 Participants n=10 Participants	74 Participants n=115 Participants
Sex: Female, Male Male	9 Participants n=5 Participants	9 Participants n=7 Participants	9 Participants n=5 Participants	9 Participants n=4 Participants	9 Participants n=21 Participants	9 Participants n=10 Participants	54 Participants n=115 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants	1 Participants n=4 Participants	2 Participants n=21 Participants	1 Participants n=10 Participants	11 Participants n=115 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	19 Participants n=5 Participants	25 Participants n=7 Participants	19 Participants n=5 Participants	18 Participants n=4 Participants	18 Participants n=21 Participants	18 Participants n=10 Participants	117 Participants n=115 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	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 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	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	2 Participants n=115 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	8 Participants n=7 Participants	2 Participants n=5 Participants	2 Participants n=4 Participants	3 Participants n=21 Participants	3 Participants n=10 Participants	20 Participants n=115 Participants
Race (NIH/OMB) White	18 Participants n=5 Participants	19 Participants n=7 Participants	18 Participants n=5 Participants	17 Participants n=4 Participants	16 Participants n=21 Participants	16 Participants n=10 Participants	104 Participants n=115 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=10 Participants	2 Participants n=115 Participants
Race (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	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants
Region of Enrollment United States	21 Participants n=5 Participants	27 Participants n=7 Participants	22 Participants n=5 Participants	19 Participants n=4 Participants	20 Participants n=21 Participants	19 Participants n=10 Participants	128 Participants n=115 Participants

PRIMARY outcome

Timeframe: Baseline, 30 minutes

Population: 3 participants were excluded due to inadequate saliva samples.

Determination of SARS-CoV-2 viral RNA in COVID+ patient saliva using Quantitative Polymerase Chain Reaction (qPCR).

Outcome measures

Outcome measures
Measure	0.9% w/v NaCl n=21 Participants Subject participants will rinse mouth one time for 60 seconds with 10 mL of 0.9% w/v NaCl. 0.9% w/v NaCl: Saline placebo rinse	27% Ethanol Plus Essential Oils n=27 Participants Subject participants will rinse mouth one time for 60 seconds with 10 mL 27% ethanol plus essential oils. 27% Ethanol plus essential oils: Over-the-counter antiseptic mouth rinse	0.075% Cetylpyridinium Chloride n=22 Participants Subject participants will rinse mouth one time for 60 seconds with 10 mL 0.075% Cetylpyridinium Chloride. 0.075% Cetylpyridinium Chloride: Over-the-counter antiseptic mouth rinse	1.5% w/v Hydrogen Peroxide n=19 Participants Subject participants will rinse mouth one time for 60 seconds with 10 mL of 1.5% w/v hydrogen peroxide rinse. 1.5% w/v Hydrogen Peroxide: Over-the-counter antiseptic mouth rinse	0.5% w/v Povidone-iodide n=18 Participants Subject participants will rinse mouth one time for 60 seconds with 10 mL .5% w/v povidone-iodide. 0.5% w/v Povidone-iodide: Over-the-counter antiseptic mouth rinse	0.12% Chlorhexidine Gluconate n=18 Participants Subject participants will rinse mouth one time for 60 seconds with 10 mL of 0.12% Chlorhexidine Gluconate. 0.12% Chlorohexidine Gluconate: Dentist prescribed antimicrobial mouth rinse
Change in Salivary Viral RNA Level of SARS-CoV-2 SARS CoV-2 N1	-209759 copies/20μL sample Standard Deviation 856748.68	-6298 copies/20μL sample Standard Deviation 34132.53	-386 copies/20μL sample Standard Deviation 8311.31	-44851 copies/20μL sample Standard Deviation 115895.74	-5319 copies/20μL sample Standard Deviation 24672.60	8318 copies/20μL sample Standard Deviation 26480.13
Change in Salivary Viral RNA Level of SARS-CoV-2 SARS CoV-2 N2	-440282 copies/20μL sample Standard Deviation 1807805.86	-1818 copies/20μL sample Standard Deviation 22088.58	32 copies/20μL sample Standard Deviation 8030.75	-79681 copies/20μL sample Standard Deviation 209740.80	-7195 copies/20μL sample Standard Deviation 24253.04	-2999 copies/20μL sample Standard Deviation 34067.65

PRIMARY outcome

Timeframe: Baseline, 30 Minutes

Population: The proposed qPCR method proved feasible with an updated protocol. As a result, the alternative method (i.e., rapid antigen test) was unnecessary and therefore not conducted.

Determination of SARS-CoV-2 protein antigen levels in COVID+ patient saliva using rapid antigen test as back-up if qPCR analysis is not possible. If the Rapid Antigen Test is needed and proves infeasible, an alternative test (i.e., sandwich ELISA) will be used.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Baseline, 30 minutes

Population: The proposed qPCR method proved feasible with an updated protocol. As a result, the alternative method (i.e., sandwich ELISA assay) was unnecessary and therefore not conducted.

Determination of SARS-CoV-2 protein antigen levels in COVID+ patient saliva using sandwich ELISA assay as back-up if qPCR analysis is not possible. If the sandwich ELISA assay proves infeasible, an alternative test (i.e., Rapid Antigen Test) will be used.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, 30 Minutes

Determination of SARS-CoV-2 viral infectivity using an in vitro infectivity assay.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: After using mouthrinse, between 0-minute and 15-minute saliva collection

The Mouthrinse questionnaire was used to understand the acceptability of mouthrinse use by participants in a clinical setting. It asks participants to respond to 14 questions answering the following: "As I read the following list of situations, please tell me how willing you would be to using a mouth rinse in that situation." Possible responses for each question are: ("Very willing"; "Somewhat willing"; "Somewhat unwilling"; "Very unwilling"; and "NA").