Trial Outcomes & Findings for APT™ T3X on the COVID-19 Contamination Rate (NCT NCT04716426)
NCT ID: NCT04716426
Last Updated: 2021-04-08
Results Overview
Rate of how many people were infected with COVID-19 over the course of the study in each group.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
100 participants
Primary outcome timeframe
22 days after randomization.
Results posted on
2021-04-08
Participant Flow
The study was performed between January 28, 2021 and March 25, 2021. The volunteers were recruited at Santa Casa de Misericórdia de Porto Alegre, Porto Alegre, Rio Grande do Sul, Brazil.
Participant milestones
| Measure |
Tetracycline Hydrochloride 3%
4 drops of tetracycline hydrochloride 3% (APT™ T3X) applied inside of the nasal channels and inside of nostrils, once a day, every day for 21 days (except health professionals that will be instructed to use 4 drops of APT™ T3X twice a day, every day for 21 days.
Tetracycline hydrochloride 3%: Proprietary formulation composed of FDA approved inactive ingredients and the active pharmaceutical ingredient tetracycline hydrochloride.
|
Placebo
4 drops of placebo applied inside of the nasal channels and inside of nostrils, once a day, every day for 21 days (except health professionals that will be instructed to use 4 drops of APT™ T3X twice a day, every day for 21 days.
Placebo: Formulation composed of FDA approved inactive ingredients.
|
|---|---|---|
|
Overall Study
STARTED
|
50
|
50
|
|
Overall Study
COMPLETED
|
48
|
49
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
| Measure |
Tetracycline Hydrochloride 3%
4 drops of tetracycline hydrochloride 3% (APT™ T3X) applied inside of the nasal channels and inside of nostrils, once a day, every day for 21 days (except health professionals that will be instructed to use 4 drops of APT™ T3X twice a day, every day for 21 days.
Tetracycline hydrochloride 3%: Proprietary formulation composed of FDA approved inactive ingredients and the active pharmaceutical ingredient tetracycline hydrochloride.
|
Placebo
4 drops of placebo applied inside of the nasal channels and inside of nostrils, once a day, every day for 21 days (except health professionals that will be instructed to use 4 drops of APT™ T3X twice a day, every day for 21 days.
Placebo: Formulation composed of FDA approved inactive ingredients.
|
|---|---|---|
|
Overall Study
Vaccination
|
1
|
1
|
|
Overall Study
Contamination
|
1
|
0
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Tetracycline Hydrochloride 3%
n=50 Participants
4 drops of tetracycline hydrochloride 3% (APT™ T3X) applied inside of the nasal channels and inside of nostrils, once a day, every day for 21 days (except health professionals that will be instructed to use 4 drops of APT™ T3X twice a day, every day for 21 days.
Tetracycline hydrochloride 3%: Proprietary formulation composed of FDA approved inactive ingredients and the active pharmaceutical ingredient tetracycline hydrochloride.
|
Placebo
n=50 Participants
4 drops of placebo applied inside of the nasal channels and inside of nostrils, once a day, every day for 21 days (except health professionals that will be instructed to use 4 drops of APT™ T3X twice a day, every day for 21 days.
Placebo: Formulation composed of FDA approved inactive ingredients.
|
Total
n=100 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
38.96 years
STANDARD_DEVIATION 13.66 • n=50 Participants
|
43.10 years
STANDARD_DEVIATION 13.49 • n=50 Participants
|
41.03 years
STANDARD_DEVIATION 13.67 • n=100 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=50 Participants
|
23 Participants
n=50 Participants
|
50 Participants
n=100 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=50 Participants
|
27 Participants
n=50 Participants
|
50 Participants
n=100 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Brazil
|
50 participants
n=50 Participants
|
50 participants
n=50 Participants
|
100 participants
n=100 Participants
|
|
Height
|
169 cm
STANDARD_DEVIATION 8 • n=50 Participants
|
169 cm
STANDARD_DEVIATION 10 • n=50 Participants
|
169 cm
STANDARD_DEVIATION 9.30 • n=100 Participants
|
|
Weight
|
78.55 Kg
STANDARD_DEVIATION 14.81 • n=50 Participants
|
78.68 Kg
STANDARD_DEVIATION 15.69 • n=50 Participants
|
78.62 Kg
STANDARD_DEVIATION 15.19 • n=100 Participants
|
|
Comorbidities
|
14 participants
n=50 Participants
|
13 participants
n=50 Participants
|
27 participants
n=100 Participants
|
PRIMARY outcome
Timeframe: 22 days after randomization.Rate of how many people were infected with COVID-19 over the course of the study in each group.
Outcome measures
| Measure |
Placebo
n=50 Participants
4 drops of placebo applied inside of the nasal channels and inside of nostrils, once a day, every day for 21 days (except health professionals that will be instructed to use 4 drops of APT™ T3X twice a day, every day for 21 days.
Placebo: Formulation composed of FDA approved inactive ingredients.
|
Tetracycline Hydrochloride 3%
n=50 Participants
4 drops of tetracycline hydrochloride 3% (APT™ T3X) applied inside of the nasal channels and inside of nostrils, once a day, every day for 21 days (except health professionals that will be instructed to use 4 drops of APT™ T3X twice a day, every day for 21 days.
Tetracycline hydrochloride 3%: Proprietary formulation composed of FDA approved inactive ingredients and the active pharmaceutical ingredient tetracycline hydrochloride.
|
|---|---|---|
|
COVID-19 Contamination Rate.
|
5 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 22 days after randomization.Number of participants who presented adverse events.
Outcome measures
| Measure |
Placebo
n=50 Participants
4 drops of placebo applied inside of the nasal channels and inside of nostrils, once a day, every day for 21 days (except health professionals that will be instructed to use 4 drops of APT™ T3X twice a day, every day for 21 days.
Placebo: Formulation composed of FDA approved inactive ingredients.
|
Tetracycline Hydrochloride 3%
n=50 Participants
4 drops of tetracycline hydrochloride 3% (APT™ T3X) applied inside of the nasal channels and inside of nostrils, once a day, every day for 21 days (except health professionals that will be instructed to use 4 drops of APT™ T3X twice a day, every day for 21 days.
Tetracycline hydrochloride 3%: Proprietary formulation composed of FDA approved inactive ingredients and the active pharmaceutical ingredient tetracycline hydrochloride.
|
|---|---|---|
|
Number of Participants With Adverse Events
|
23 participants
|
17 participants
|
SECONDARY outcome
Timeframe: 22 days after randomization.Average number of adverse events over the course of the study.
Outcome measures
| Measure |
Placebo
n=50 Participants
4 drops of placebo applied inside of the nasal channels and inside of nostrils, once a day, every day for 21 days (except health professionals that will be instructed to use 4 drops of APT™ T3X twice a day, every day for 21 days.
Placebo: Formulation composed of FDA approved inactive ingredients.
|
Tetracycline Hydrochloride 3%
n=50 Participants
4 drops of tetracycline hydrochloride 3% (APT™ T3X) applied inside of the nasal channels and inside of nostrils, once a day, every day for 21 days (except health professionals that will be instructed to use 4 drops of APT™ T3X twice a day, every day for 21 days.
Tetracycline hydrochloride 3%: Proprietary formulation composed of FDA approved inactive ingredients and the active pharmaceutical ingredient tetracycline hydrochloride.
|
|---|---|---|
|
Average Number of Adverse Events
|
0.94 adverse events
Standard Deviation 1.25
|
0.65 adverse events
Standard Deviation 1.11
|
SECONDARY outcome
Timeframe: 22 days after randomization.Average days over which an adverse event was reported.
Outcome measures
| Measure |
Placebo
n=50 Participants
4 drops of placebo applied inside of the nasal channels and inside of nostrils, once a day, every day for 21 days (except health professionals that will be instructed to use 4 drops of APT™ T3X twice a day, every day for 21 days.
Placebo: Formulation composed of FDA approved inactive ingredients.
|
Tetracycline Hydrochloride 3%
n=50 Participants
4 drops of tetracycline hydrochloride 3% (APT™ T3X) applied inside of the nasal channels and inside of nostrils, once a day, every day for 21 days (except health professionals that will be instructed to use 4 drops of APT™ T3X twice a day, every day for 21 days.
Tetracycline hydrochloride 3%: Proprietary formulation composed of FDA approved inactive ingredients and the active pharmaceutical ingredient tetracycline hydrochloride.
|
|---|---|---|
|
Days Over Which an Adverse Event Was Reported
|
0.28 Days
Standard Deviation 1.67
|
0.36 Days
Standard Deviation 2.2
|
SECONDARY outcome
Timeframe: 22 days after randomization.Rate of how many people were infected with influenza or pneumonia over the course of the study in each group.
Outcome measures
| Measure |
Placebo
n=50 Participants
4 drops of placebo applied inside of the nasal channels and inside of nostrils, once a day, every day for 21 days (except health professionals that will be instructed to use 4 drops of APT™ T3X twice a day, every day for 21 days.
Placebo: Formulation composed of FDA approved inactive ingredients.
|
Tetracycline Hydrochloride 3%
n=50 Participants
4 drops of tetracycline hydrochloride 3% (APT™ T3X) applied inside of the nasal channels and inside of nostrils, once a day, every day for 21 days (except health professionals that will be instructed to use 4 drops of APT™ T3X twice a day, every day for 21 days.
Tetracycline hydrochloride 3%: Proprietary formulation composed of FDA approved inactive ingredients and the active pharmaceutical ingredient tetracycline hydrochloride.
|
|---|---|---|
|
Other Virus or Bacteria Contamination Rate.
|
0 Participants
|
0 Participants
|
Adverse Events
Tetracycline Hydrochloride 3%
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 23 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Tetracycline Hydrochloride 3%
n=50 participants at risk
4 drops of tetracycline hydrochloride 3% (APT™ T3X) applied inside of the nasal channels and inside of nostrils, once a day, every day for 21 days (except health professionals that will be instructed to use 4 drops of APT™ T3X twice a day, every day for 21 days.
Tetracycline hydrochloride 3%: Proprietary formulation composed of FDA approved inactive ingredients and the active pharmaceutical ingredient tetracycline hydrochloride.
|
Placebo
n=50 participants at risk
4 drops of placebo applied inside of the nasal channels and inside of nostrils, once a day, every day for 21 days (except health professionals that will be instructed to use 4 drops of APT™ T3X twice a day, every day for 21 days.
Placebo: Formulation composed of FDA approved inactive ingredients.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Itch
|
10.0%
5/50 • Number of events 46 • 22 days
The adverse events were collected through a diary filled by the volunteers during the trial.
|
8.0%
4/50 • Number of events 17 • 22 days
The adverse events were collected through a diary filled by the volunteers during the trial.
|
|
Respiratory, thoracic and mediastinal disorders
Coryza
|
4.0%
2/50 • Number of events 4 • 22 days
The adverse events were collected through a diary filled by the volunteers during the trial.
|
8.0%
4/50 • Number of events 25 • 22 days
The adverse events were collected through a diary filled by the volunteers during the trial.
|
|
Respiratory, thoracic and mediastinal disorders
Sneeze
|
22.0%
11/50 • Number of events 84 • 22 days
The adverse events were collected through a diary filled by the volunteers during the trial.
|
24.0%
12/50 • Number of events 35 • 22 days
The adverse events were collected through a diary filled by the volunteers during the trial.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal irritation
|
4.0%
2/50 • Number of events 26 • 22 days
The adverse events were collected through a diary filled by the volunteers during the trial.
|
8.0%
4/50 • Number of events 25 • 22 days
The adverse events were collected through a diary filled by the volunteers during the trial.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/50 • 22 days
The adverse events were collected through a diary filled by the volunteers during the trial.
|
6.0%
3/50 • Number of events 15 • 22 days
The adverse events were collected through a diary filled by the volunteers during the trial.
|
|
Eye disorders
Shed tears
|
10.0%
5/50 • Number of events 60 • 22 days
The adverse events were collected through a diary filled by the volunteers during the trial.
|
8.0%
4/50 • Number of events 31 • 22 days
The adverse events were collected through a diary filled by the volunteers during the trial.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal burning
|
8.0%
4/50 • Number of events 24 • 22 days
The adverse events were collected through a diary filled by the volunteers during the trial.
|
14.0%
7/50 • Number of events 32 • 22 days
The adverse events were collected through a diary filled by the volunteers during the trial.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
2.0%
1/50 • Number of events 2 • 22 days
The adverse events were collected through a diary filled by the volunteers during the trial.
|
4.0%
2/50 • Number of events 8 • 22 days
The adverse events were collected through a diary filled by the volunteers during the trial.
|
|
Ear and labyrinth disorders
Earache
|
2.0%
1/50 • Number of events 2 • 22 days
The adverse events were collected through a diary filled by the volunteers during the trial.
|
0.00%
0/50 • 22 days
The adverse events were collected through a diary filled by the volunteers during the trial.
|
|
Injury, poisoning and procedural complications
Nosebleed
|
2.0%
1/50 • Number of events 2 • 22 days
The adverse events were collected through a diary filled by the volunteers during the trial.
|
2.0%
1/50 • Number of events 1 • 22 days
The adverse events were collected through a diary filled by the volunteers during the trial.
|
|
Cardiac disorders
Hypotension
|
0.00%
0/50 • 22 days
The adverse events were collected through a diary filled by the volunteers during the trial.
|
2.0%
1/50 • Number of events 1 • 22 days
The adverse events were collected through a diary filled by the volunteers during the trial.
|
|
Musculoskeletal and connective tissue disorders
Pain in the face
|
0.00%
0/50 • 22 days
The adverse events were collected through a diary filled by the volunteers during the trial.
|
2.0%
1/50 • Number of events 1 • 22 days
The adverse events were collected through a diary filled by the volunteers during the trial.
|
|
Respiratory, thoracic and mediastinal disorders
Dry nose
|
0.00%
0/50 • 22 days
The adverse events were collected through a diary filled by the volunteers during the trial.
|
2.0%
1/50 • Number of events 1 • 22 days
The adverse events were collected through a diary filled by the volunteers during the trial.
|
|
General disorders
Headache
|
0.00%
0/50 • 22 days
The adverse events were collected through a diary filled by the volunteers during the trial.
|
4.0%
2/50 • Number of events 3 • 22 days
The adverse events were collected through a diary filled by the volunteers during the trial.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place