Clinical trial NCT04716426
Conditions: COVID-19
Keywords: Prevention Tetracycline hydrochloride COVID-19
Sponsor: University of Nove de Julho
Start date: 2021-01-28; Completion date: 2021-03-25
Enrollment: 100 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The new coronavirus 2019 (COVID-19) was declared a pandemic by the World Health Organization (WHO), due to the alarming levels of spread, severity and inaction. Dealing with COVID-19 must be done on different fronts, such as mitigation, treatment and prevention. Therefore, strategies and therapies that can help reduce the COVID-19 rate of contamination are still important alternatives at this time of the pandemic.

The Advanced Penetration Technology™ (APT™) is intellectual property owned by Patient Focused Tele-Health, LLC, a Rockwall, Texas based company. The company's focus is improving over-the-counter (OTC) topical formulations, allowing consumers better therapeutic outcomes with non-prescription medications.

The Advanced Penetration Technology™ (APT™) is a patent-pending, proprietary transdermal dual carrier formulation. This formulation provides improved dermal penetration and efficacy of topical API's. Additionally, the APT™ imparts both a mechanical and biochemical effect on the microbe/fungal cell walls providing a highly effective method of destruction of microbes. These unique properties impart the broad spectrum anti-viral capability to the APT™ Tetracycline 3% formulation, breaking barriers in pharmacology and virology.

The topical formulation APT™ Tetracycline 3% formulation (APT ™ T3X), is a FDA registered, Non-Prescription product. This formulation is used in an off label manner as an intranasal application for prevention of COVID-19 and other viruses. The APT™ T3X as a topical application will penetrate through and into the mucus layer and deeper. This barrier of coverage will provide a mitigation effect to decrease the viral load of exposure and infection. The efficacy of APT™ T3X is due to disrupting the lipid envelope in seconds, hence neutralizing the virus.

Previous tests were performed with APT™ T3X and the results found were promising. However, these tests were performed only in vitro and clinical studies demonstrating the ability of the APT™ T3X to decrease viral exposure and contamination by COVID-19 are necessary to confirm the possible prophylactic effect, allowing the formulation to be widely distributed to the general population.

Therefore, the aim of this project is to evaluate the efficacy of the APT™ T3X compared to placebo to decrease COVID-19 contamination rate in humans.

Detailed description:
To achieve the proposed objective it will be performed a randomized, triple blind, placebo-controlled trial. The volunteers will be randomly allocated to two intervention groups: APT™ T3X or placebo. The volunteers will be blinded to the treatment received.

One hundred volunteers will be recruited for the study (50 volunteers per group). As this is a preliminary study, the number of volunteers was determined by a convenience sample.

The volunteers randomly allocated to the two groups will be instructed to use the APT™ T3X or placebo, once a day, every day for 21 days (except health professionals that will be instructed to use APT™ T3X or placebo twice a day, every day for 21 days).

All data will be collected by a blinded assessor. The investigators will analyze:

1. COVID-19 contamination rate.
2. Presence of adverse events.
3. Number of adverse events.
4. Frequency of adverse events.
5. Other virus or bacteria contamination rate.

Statistical analysis: The results obtained will first be tested for normality using the Kolmogorov-Smirnov test. The chi-square test or Fisher's exact test for two independent proportions will be used in the statistical analysis of the primary outcome of this study, the COVID-19 contamination rate and for the secondary outcomes: presence of adverse events and other virus or bacteria contamination rate. For the other secondary outcomes, the number of adverse events and frequency of adverse events, the Wilcoxon test will be used if this outcome does not present a normal distribution. If this outcome presents a normal distribution, the two-tailed, unpaired t test will be used. The level of significance used will be 5% (p \<0.05).

Arms: arm 1: 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. arm 2: 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.
Interventions: intervention 1: Tetracycline hydrochloride 3% intervention 2: Placebo
Intervention descriptions: intervention 1: Proprietary formulation composed of FDA approved inactive ingredients and the active pharmaceutical ingredient tetracycline hydrochloride. intervention 2: Formulation composed of FDA approved inactive ingredients.

Protocol documents:
Prot_SAP_000.pdf: 
 
 
 
 
 
 
 
 
Use of APT™ T3X to decrease the COVID-19  
contamination rate in humans 
NCT04716426 
 
 
 
 
 
 
 
 
Porto Alegre, December 28th 2020.


 
Background and aim 
 
The new coronavirus 2019 (COVID-19) was declared a pandemic by the World Health 
Organization (WHO) due to the alarming levels of spread, severity and inaction. COVID-19 is 
caused by the SARS-CoV-2 virus (severe acute respiratory syndrome of coronavirus 2). The main 
clinical characteristics observed in patients infected with COVID-19 are: fever, dry cough, fatigue 
or myalgia. Patients infected with COVID-19 can present from no symptoms to pneumonia and 
death. Dealing with COVID-19 must be done on different fronts, such as mitigation, treatment and 
prevention. Therefore, strategies and therapies that can help reduce the COVID-19 rate of 
contamination are still important alternatives at this time of the pandemic, especially when 
mutations of the virus have been observed worldwide.  
The Advanced Penetration Technology™ (APT™) is intellectual property owned by 
Patient Focused Tele-Health, LLC, a Rockwall, Texas based company. The company’s focus is 
improving over-the-counter (OTC) topical formulations, allowing consumers better therapeutic 
outcomes with non-prescription medications. The Advanced Penetration Technology™ (APT™) 
is a patent-pending, proprietary transdermal dual carrier formulation. This formulation provides 
improved dermal penetration and efficacy of topical API’s. Additionally, the APT™ imparts both 
a mechanical and biochemical effect on the microbe/fungal cell walls providing a highly effective 
method of destruction of microbes. These unique properties impart the broad spectrum anti-viral 
capability to the APT™ Tetracycline 3% formulation, breaking barriers in pharmacology and 
virology. 
The topical formulation APT™ Tetracycline 3% formulation (APT™ T3X), is a FDA 
registered, non-prescription product. This formulation is used in an off-label manner as an 
intranasal application for prevention of COVID-19 and other viruses. The APT™ T3X as a topical 
application will penetrate through and into the mucus layer and deeper. This barrier of coverage 
will provide a mitigation effect to decrease the viral load of exposure and infection. The efficacy 
of APT™ T3X is due to disrupting the lipid envelope in seconds, hence neutralizing the virus. 
Previous tests were performed with APT™ T3X and the results found were promising. However, 
these tests were performed only in vitro and clinical studies demonstrating the ability of the APT™ 
T3X to decrease viral exposure and contamination by COVID-19 are necessary to confirm the 
possible prophylactic effect, allowing the formulation to be widely distributed to the general 
population. 


 
Therefore, the aim of this project will be to evaluate the efficacy of the APT™ T3X 
compared to placebo to decrease COVID-19 contamination rate in humans. 
 
 


 
Methods 
 
Trial design 
A two-arm, parallel randomized, triple-blinded (volunteers, care provider, and outcome 
assessor), placebo-controlled trial will be carried out. This trial it will be prospectively registered 
on clinicaltrials.gov. 
 
Ethics 
This study was submitted and approved by the Research Ethics Committee of Irmandade 
da Santa Casa de Misericórdia de Porto Alegre – ISCMPA, Porto Alegre, Rio Grande do Sul, 
Brazil, under protocol number 4.485.847. This trial will be performed in accordance with the 
Declaration of Helsinki and the guidelines for research involving human subjects. All volunteers 
will sign the written informed consent before enrolment in the study. 
 
Volunteers and recruitment 
One hundred volunteers will be included in the trial (fifty volunteers per group). The 
inclusion criteria will be: over 18 years; good general health (without serious health problems); 
tested negative, by means of immunoglobulin (Ig) G and IgM serology tests and chain real-time 
polymerase chain reaction (RT-PCR), for COVID-19. The exclusion criteria will be: previous 
immunization against COVID-19; allergy to tetracycline hydrochloride; diagnosis of Lyme 
disease; immunocompromised; share housing with someone diagnosed with COVID-19 at the time 
of the baseline evaluation; serious illnesses, such as cancer, kidney failure, decompensated 
cardiorespiratory and metabolic diseases, etc. 
 
Randomization and blinding 
Prior to initiation of the treatment, patients will be randomized into their respective 
intervention groups: APT™ T3X or placebo. Randomization will be generated by a website 
(http://random.org/) and performed by a participating researcher not involved in the recruitment 
and evaluation of the volunteers. This researcher will be instructed not to disclose the 


 
randomization codes in the intervention groups to any of the volunteers and to the other researchers 
involved in the study, until its completion. The intervention bottles will be exactly the same 
regardless of whether it was APT™ T3X or placebo. Concealed allocation will be achieved 
through the use of sequentially numbered, sealed, and opaque envelopes. 
 
Interventions 
Volunteers will be instructed to use the intervention, according to the prior randomization, 
once a day, every day, for 21 days. If the volunteer is health professional, it will be instructed to 
use the intervention twice a day, every day, for 21 days. Intervention specifications included: 
1) APT™ T3X: The volunteers will be instructed to use 4 drops of tetracycline hydrochloride 
3% (APT™ T3X) applied inside of the nasal channels and inside of nostrils. 
2) Placebo: The volunteers will be instructed to use 4 drops of a formulation composed of 
FDA approved inactive ingredients applied inside of the nasal channels and inside of 
nostrils. 
All volunteers will be instructed to record each intervention application and to send to a 
member of the research team in order to control and ensure the adherence to treatment. 
 
Outcomes 
Primary outcome 
The primary outcome measured will be the rate of contamination by COVID-19 measured 
through the rate of how many people will be infected with COVID-19 over the course of the study 
in each group. This outcome will be measured 22 days after the randomization i.e., after 21 days 
of application with APT™ T3X or placebo. 
Secondary outcomes 
The secondary outcomes will be presence of adverse events, number of adverse events and 
frequency of adverse events measured through self-report. In addition, other virus or bacteria 
contamination rate will be measured through the rate of how many people will be infected with 
influenza or pneumonia over the course of the study in each group. All secondary outcomes will 
be measured 22 days after the randomization i.e., after 21 days of application with APT ™ T3X 
or placebo. 


 
Statistical analysis 
 
The results obtained will first be tested for normality using the Kolmogorov-Smirnov test. 
The chi-square test or Fisher's exact test for two independent proportions will be used in the 
statistical analysis of the primary outcome of this study, the COVID-19 contamination rate and for 
the secondary outcomes: presence of adverse events and another virus or bacteria contamination 
rate. For the other secondary outcomes, the number of adverse events and frequency of adverse 
events, the Wilcoxon test will be used if this outcome does not present a normal distribution. If 
this outcome presents a normal distribution, the two-tailed, unpaired t test will be used. The level 
of significance used will be 5% (p <0.05).