Trial Outcomes & Findings for Antiviral Efficacy and Acceptability of Mouth Rinses for Inactivation of COVID-19 (NCT NCT04748783)

NCT ID: NCT04748783

Last Updated: 2022-02-16

Results Overview

Determination of (RT-PCR) of inactivity of SARS-CoV-2 cellular infectivity in COVID+ patient saliva

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

2 participants

Primary outcome timeframe

Baseline, 15 minutes

Results posted on

2022-02-16

Participant Flow

Participant milestones

Participant milestones
Measure	Sterile Water Subject participants will rinse mouth one time for 60 seconds with 10 mL of sterile water	Peroxyl Subject participants will rinse mouth one time for 60 seconds with 10 mL Peroxyl (1.5% w/v hydrogen peroxide) rinse	Periogard Subject participants will rinse mouth one time for 60 seconds with 10 mL Periogard (0.12% Chlorhexidine Gluconate) rinse	Peroxyl & Periogard Subject participants will complete an on-label sequential rinse starting with Peroxyl (1.5% w/v hydrogen peroxide) 10 mL for 60 seconds and then Periogard (0.12% Chlorhexidine Gluconate) 15 mL for 30 seconds	Colgate Total Zero Subject participants will rinse mouth one time with Colgate Total Zero Fresh Breath (0.075% Cetylpyridinium Chloride) 20 mL for 30 seconds
Overall Study STARTED	0	1	0	0	1
Overall Study COMPLETED	0	1	0	0	1
Overall Study NOT COMPLETED	0	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Antiviral Efficacy and Acceptability of Mouth Rinses for Inactivation of COVID-19

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Sterile Water Subject participants will rinse mouth one time for 60 seconds with 10 mL of sterile water	Peroxyl n=1 Participants Subject participants will rinse mouth one time for 60 seconds with 10 mL Peroxyl (1.5% w/v hydrogen peroxide) rinse	Periogard Subject participants will rinse mouth one time for 60 seconds with 10 mL Periogard (0.12% Chlorhexidine Gluconate) rinse.	Peroxyl & Periogard Subject participants will complete an on-label sequential rinse starting with Peroxyl (1.5% w/v hydrogen peroxide) 10 mL for 60 seconds and then Periogard (0.12% Chlorhexidine Gluconate) 15 mL for 30 seconds.	Colgate Total Zero n=1 Participants Subject participants will rinse mouth one time with Colgate Total Zero Fresh Breath (0.075% Cetylpyridinium Chloride) 20 mL for 30 seconds	Total n=2 Participants Total of all reporting groups
Age, Categorical <=18 years	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
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	2 Participants n=10 Participants
Age, Categorical >=65 years	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
Sex: Female, Male Female	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	2 Participants n=10 Participants
Sex: Female, Male Male	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
Ethnicity (NIH/OMB) Hispanic or Latino	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
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	2 Participants n=10 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
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
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	—	0 Participants n=21 Participants	0 Participants n=10 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
Race (NIH/OMB) Black or African American	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
Race (NIH/OMB) White	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	2 Participants n=10 Participants
Race (NIH/OMB) More than one race	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
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
Region of Enrollment United States	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	2 Participants n=10 Participants

PRIMARY outcome

Timeframe: Baseline, 15 minutes

Population: Due to early termination of the study, the biospecimen samples were destroyed and never analyzed.

Determination of (RT-PCR) of inactivity of SARS-CoV-2 cellular infectivity in COVID+ patient saliva

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Baseline, 30 Minutes

Population: Due to early termination of the study, the biospecimen samples were destroyed and never analyzed.

Determination of (RT-PCR) of inactivity of SARS-CoV-2 cellular infectivity in COVID+ patient saliva

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Baseline, 45 Minutes

Population: Due to early termination of the study, the biospecimen samples were destroyed and never analyzed.

Determination of (RT-PCR) of inactivity of SARS-CoV-2 cellular infectivity in COVID+ patient

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Baseline, 60 minutes

Population: Due to early termination of the study, the biospecimen samples were destroyed and never analyzed.

Determination of (RT-PCR) of inactivity of SARS-CoV-2 cellular infectivity in COVID+ patient

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Baseline, 1 week

Population: Due to early termination of the study, the biospecimen samples were destroyed and never analyzed.

Determination of (RT-PCR) of inactivity of SARS-CoV-2 cellular infectivity in COVID+ patient

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, 1 week

Population: Due to early termination of the study, the biospecimen samples were destroyed and never analyzed.

Change in inflammation-associated cytokine concentration (pg/mL) in saliva

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, 1 week

Population: Due to early termination of the study, the biospecimen samples were destroyed and never analyzed.

Change in inflammation-associated cytokine concentration (pg/mL) in Blood

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, 1 week

Population: Due to early termination of the study, the biospecimen samples were destroyed and never analyzed.

Change in inflammation-associated chemokine concentration (pg/mL) in saliva

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, 1 week

Population: Due to early termination of the study, the biospecimen samples were destroyed and never analyzed.

Change in inflammation-associated chemokine concentration (pg/mL) in Blood

Outcome measures

Outcome data not reported

Adverse Events

Sterile Water

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Peroxyl

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Periogard

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Peroxyl & Periogard

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Colgate Total Zero

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, MS

University of North Carolina at Chapel Hill

Phone: 919-537-3424

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place