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APT™ T3X on the COVID-19 Contamination Rate

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ClinicalTrials.gov Identifier: NCT04716426
Recruitment Status : Completed
First Posted : January 20, 2021
Results First Posted : April 8, 2021
Last Update Posted : April 8, 2021
Sponsor:
Collaborator:
Santa Casa de Misericórdia de Porto Alegre
Information provided by (Responsible Party):
Ernesto Cesar Pinto Leal Junior, University of Nove de Julho

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition COVID-19
Interventions Drug: Tetracycline hydrochloride 3%
Drug: Placebo
Enrollment 100
Recruitment Details 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.
Pre-assignment Details  
Arm/Group Title Tetracycline Hydrochloride 3% Placebo
Hide Arm/Group Description

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.

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.

Period Title: Overall Study
Started 50 50
Completed 48 49
Not Completed 2 1
Reason Not Completed
Vaccination             1             1
Contamination             1             0
Arm/Group Title Tetracycline Hydrochloride 3% Placebo Total
Hide Arm/Group Description

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.

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 of all reporting groups
Overall Number of Baseline Participants 50 50 100
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 50 participants 50 participants 100 participants
38.96  (13.66) 43.10  (13.49) 41.03  (13.67)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants 50 participants 100 participants
Female 27 23 50
Male 23 27 50
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 0 participants
0
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Brazil Number Analyzed 50 participants 50 participants 100 participants
50 50 100
Height  
Mean (Standard Deviation)
Unit of measure:  Cm
Number Analyzed 50 participants 50 participants 100 participants
169  (8) 169  (10) 169  (9.30)
Weight  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 50 participants 50 participants 100 participants
78.55  (14.81) 78.68  (15.69) 78.62  (15.19)
Comorbidities  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 50 participants 50 participants 100 participants
14 13 27
1.Primary Outcome
Title COVID-19 Contamination Rate.
Hide Description Rate of how many people were infected with COVID-19 over the course of the study in each group.
Time Frame 22 days after randomization.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Tetracycline Hydrochloride 3% Placebo
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 50 50
Measure Type: Count of Participants
Unit of Measure: Participants
2
   4.0%
5
  10.0%
2.Secondary Outcome
Title Number of Participants With Adverse Events
Hide Description Number of participants who presented adverse events.
Time Frame 22 days after randomization.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Tetracycline Hydrochloride 3% Placebo
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 50 50
Measure Type: Number
Unit of Measure: participants
17 23
3.Secondary Outcome
Title Average Number of Adverse Events
Hide Description Average number of adverse events over the course of the study.
Time Frame 22 days after randomization.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Tetracycline Hydrochloride 3% Placebo
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 50 50
Mean (Standard Deviation)
Unit of Measure: adverse events
0.65  (1.11) 0.94  (1.25)
4.Secondary Outcome
Title Days Over Which an Adverse Event Was Reported
Hide Description Average days over which an adverse event was reported.
Time Frame 22 days after randomization.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Tetracycline Hydrochloride 3% Placebo
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 50 50
Mean (Standard Deviation)
Unit of Measure: Days
0.36  (2.2) 0.28  (1.67)
5.Secondary Outcome
Title Other Virus or Bacteria Contamination Rate.
Hide Description Rate of how many people were infected with influenza or pneumonia over the course of the study in each group.
Time Frame 22 days after randomization.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Tetracycline Hydrochloride 3% Placebo
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 50 50
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
Time Frame 22 days
Adverse Event Reporting Description The adverse events were collected through a diary filled by the volunteers during the trial.
 
Arm/Group Title Tetracycline Hydrochloride 3% Placebo
Hide Arm/Group Description

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.

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.

All-Cause Mortality
Tetracycline Hydrochloride 3% Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/50 (0.00%)      0/50 (0.00%)    
Hide Serious Adverse Events
Tetracycline Hydrochloride 3% Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/50 (0.00%)      0/50 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Tetracycline Hydrochloride 3% Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   17/50 (34.00%)      23/50 (46.00%)    
Cardiac disorders     
Hypotension *  0/50 (0.00%)  0 1/50 (2.00%)  1
Ear and labyrinth disorders     
Earache *  1/50 (2.00%)  2 0/50 (0.00%)  0
Eye disorders     
Shed tears *  5/50 (10.00%)  60 4/50 (8.00%)  31
General disorders     
Headache *  0/50 (0.00%)  0 2/50 (4.00%)  3
Injury, poisoning and procedural complications     
Nosebleed *  1/50 (2.00%)  2 1/50 (2.00%)  1
Musculoskeletal and connective tissue disorders     
Pain in the face *  0/50 (0.00%)  0 1/50 (2.00%)  1
Respiratory, thoracic and mediastinal disorders     
Itch *  5/50 (10.00%)  46 4/50 (8.00%)  17
Coryza *  2/50 (4.00%)  4 4/50 (8.00%)  25
Sneeze *  11/50 (22.00%)  84 12/50 (24.00%)  35
Nasal irritation *  2/50 (4.00%)  26 4/50 (8.00%)  25
Cough *  0/50 (0.00%)  0 3/50 (6.00%)  15
Nasal burning *  4/50 (8.00%)  24 7/50 (14.00%)  32
Nasal congestion *  1/50 (2.00%)  2 2/50 (4.00%)  8
Dry nose *  0/50 (0.00%)  0 1/50 (2.00%)  1
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Ernesto Cesar Pinto Leal Junior
Organization: ELJ Consultancy
Phone: +55 11 975222856
EMail: ceo@eljconsultancy.com
Layout table for additonal information
Responsible Party: Ernesto Cesar Pinto Leal Junior, University of Nove de Julho
ClinicalTrials.gov Identifier: NCT04716426    
Other Study ID Numbers: 4.485.847
First Submitted: January 18, 2021
First Posted: January 20, 2021
Results First Submitted: March 31, 2021
Results First Posted: April 8, 2021
Last Update Posted: April 8, 2021