Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT04716426 |
Other study ID # |
4.485.847 |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
January 28, 2021 |
Est. completion date |
March 25, 2021 |
Study information
Verified date |
April 2021 |
Source |
University of Nove de Julho |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial 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.
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).