Trial Outcomes & Findings for A Pilot Study of the Safety, Tolerability, and Effectiveness of Halo (NCT NCT02644135)

NCT ID: NCT02644135

Last Updated: 2022-11-01

Results Overview

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 100 participants
• Primary outcome timeframe: Through study duration, an average of 3 months
• Results posted on: 2022-11-01

Participant Flow

Participant milestones

Measure	Halo Oral Spray Based upon the preliminary studies that assessed the duration of the antimicrobial effects of Halo as reported in the preliminary studies and feasibility, subjects assigned to both study arms will be asked to spray the product intra-orally 3 times daily (Three sprays per use, total = 9 sprays per day). Halo Oral Spray: Three sprays per use, total = 9 sprays per day	Halo Placebo The placebo will consist of purified sterile water without CPC - the active antiseptic. Subjects assigned to both study arms will be asked to spray the product intra-orally 3 times daily (Three sprays per use, total = 9 sprays per day). Halo Placebo: Three sprays per use, total = 9 sprays per day
Overall Study STARTED	50	44
Overall Study COMPLETED	50	44
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Pilot Study of the Safety, Tolerability, and Effectiveness of Halo

Baseline characteristics by cohort

Measure	Halo Oral Spray n=50 Participants Based upon the preliminary studies that assessed the duration of the antimicrobial effects of Halo as reported in the preliminary studies and feasibility, subjects assigned to both study arms will be asked to spray the product intra-orally 3 times daily (Three sprays per use, total = 9 sprays per day). Halo Oral Spray: Three sprays per use, total = 9 sprays per day	Halo Placebo n=44 Participants The placebo will consist of purified sterile water without CPC - the active antiseptic. Subjects assigned to both study arms will be asked to spray the product intra-orally 3 times daily (Three sprays per use, total = 9 sprays per day). Halo Placebo: Three sprays per use, total = 9 sprays per day	Total n=94 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
Age, Categorical Between 18 and 65 years	50 Participants n=5 Participants	44 Participants n=7 Participants	94 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	25.14 years STANDARD_DEVIATION 6.73 • n=5 Participants	24.86 years STANDARD_DEVIATION 6.47 • n=7 Participants	24.86 years STANDARD_DEVIATION 6.47 • n=5 Participants
Sex: Female, Male Female	26 Participants n=5 Participants	20 Participants n=7 Participants	46 Participants n=5 Participants
Sex: Female, Male Male	24 Participants n=5 Participants	24 Participants n=7 Participants	48 Participants n=5 Participants

PRIMARY outcome

Timeframe: Through study duration, an average of 3 months

Population: Among the 94 enrolled individuals, there were six participants who presented to the clinic for clinical confirmation and collection of oral and nasal swabs related to the development of URIs symptoms (Confirmed URIs Episode).

Outcome measures

Measure	Halo Oral Spray n=50 Participants Based upon the preliminary studies that assessed the duration of the antimicrobial effects of Halo as reported in the preliminary studies and feasibility, subjects assigned to both study arms will be asked to spray the product intra-orally 3 times daily (Three sprays per use, total = 9 sprays per day). Halo Oral Spray: Three sprays per use, total = 9 sprays per day	Halo Placebo n=44 Participants The placebo will consist of purified sterile water without CPC - the active antiseptic. Subjects assigned to both study arms will be asked to spray the product intra-orally 3 times daily (Three sprays per use, total = 9 sprays per day). Halo Placebo: Three sprays per use, total = 9 sprays per day
Number of Participants That Develop Acute Respiratory Illnesses When Using Halo vs Placebo	2 participants	4 participants

SECONDARY outcome

Timeframe: Through study duration, an average of 3 months

Measured by medical record review.

Outcome measures

Measure	Halo Oral Spray n=50 Participants Based upon the preliminary studies that assessed the duration of the antimicrobial effects of Halo as reported in the preliminary studies and feasibility, subjects assigned to both study arms will be asked to spray the product intra-orally 3 times daily (Three sprays per use, total = 9 sprays per day). Halo Oral Spray: Three sprays per use, total = 9 sprays per day	Halo Placebo n=44 Participants The placebo will consist of purified sterile water without CPC - the active antiseptic. Subjects assigned to both study arms will be asked to spray the product intra-orally 3 times daily (Three sprays per use, total = 9 sprays per day). Halo Placebo: Three sprays per use, total = 9 sprays per day
Number of Acute Respiratory Illnesses	4 Number of acute respiratory illnesses	2 Number of acute respiratory illnesses

Adverse Events

Halo Oral Spray

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Halo Placebo

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Halo Oral Spray n=50 participants at risk Based upon the preliminary studies that assessed the duration of the antimicrobial effects of Halo as reported in the preliminary studies and feasibility, subjects assigned to both study arms will be asked to spray the product intra-orally 3 times daily (Three sprays per use, total = 9 sprays per day). Halo Oral Spray: Three sprays per use, total = 9 sprays per day	Halo Placebo n=44 participants at risk The placebo will consist of purified sterile water without CPC - the active antiseptic. Subjects assigned to both study arms will be asked to spray the product intra-orally 3 times daily (Three sprays per use, total = 9 sprays per day). Halo Placebo: Three sprays per use, total = 9 sprays per day
General disorders headache	4.0% 2/50 • Number of events 2 • 3 months	4.5% 2/44 • Number of events 2 • 3 months
General disorders Anxiety	2.0% 1/50 • Number of events 1 • 3 months	2.3% 1/44 • Number of events 1 • 3 months
General disorders Labial mucosal injury	0.00% 0/50 • 3 months	2.3% 1/44 • Number of events 1 • 3 months
General disorders Muscle strain	0.00% 0/50 • 3 months	2.3% 1/44 • Number of events 1 • 3 months
General disorders extremity rash	2.0% 1/50 • Number of events 1 • 3 months	0.00% 0/44 • 3 months

Additional Information

Dr. Robert Salata

UHCMC

Phone: 2168443293

Email: robert.salata@uhhospitals.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place