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APT™ T3X on the COVID-19 Contamination Rate

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE January 18, 2021
First Posted Date  ICMJE January 20, 2021
Results First Submitted Date  ICMJE March 31, 2021
Results First Posted Date  ICMJE April 8, 2021
Last Update Posted Date April 8, 2021
Actual Study Start Date  ICMJE January 28, 2021
Actual Primary Completion Date March 25, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 18, 2021)
COVID-19 Contamination Rate. [ Time Frame: 22 days after randomization. ]
Rate of how many people were infected with COVID-19 over the course of the study in each group.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 6, 2021)
  • Number of Participants With Adverse Events [ Time Frame: 22 days after randomization. ]
    Number of participants who presented adverse events.
  • Average Number of Adverse Events [ Time Frame: 22 days after randomization. ]
    Average number of adverse events over the course of the study.
  • Days Over Which an Adverse Event Was Reported [ Time Frame: 22 days after randomization. ]
    Average days over which an adverse event was reported.
  • Other Virus or Bacteria Contamination Rate. [ Time Frame: 22 days after randomization. ]
    Rate of how many people were infected with influenza or pneumonia over the course of the study in each group.
Original Secondary Outcome Measures  ICMJE
 (submitted: January 18, 2021)
  • Presence of adverse events. [ Time Frame: 22 days after randomization. ]
    Occurrence or not of adverse events.
  • Number of adverse events. [ Time Frame: 22 days after randomization. ]
    Number of adverse events over the course of the study.
  • Frequency of adverse events. [ Time Frame: 22 days after randomization. ]
    Frequency of any reported adverse events.
  • Other Virus or Bacteria Contamination Rate. [ Time Frame: 22 days after randomization. ]
    Rate of how many people were infected with influenza or pneumonia over the course of the study in each group.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE APT™ T3X on the COVID-19 Contamination Rate
Official Title  ICMJE Use of APT™ T3X to Decrease the COVID-19 Contamination Rate in Humans
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).

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
A participating researcher not involved in the recruitment and evaluation of the volunteers will carry out the randomization process. 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 is APT™ T3X or placebo.
Primary Purpose: Prevention
Condition  ICMJE COVID-19
Intervention  ICMJE
  • Drug: Tetracycline hydrochloride 3%
    Proprietary formulation composed of FDA approved inactive ingredients and the active pharmaceutical ingredient tetracycline hydrochloride.
    Other Name: APT™T3X
  • Drug: Placebo
    Formulation composed of FDA approved inactive ingredients.
Study Arms  ICMJE
  • Experimental: 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.
    Intervention: Drug: Tetracycline hydrochloride 3%
  • Placebo Comparator: 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.
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 18, 2021)
100
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 25, 2021
Actual Primary Completion Date March 25, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04716426
Other Study ID Numbers  ICMJE 4.485.847
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ernesto Cesar Pinto Leal Junior, University of Nove de Julho
Study Sponsor  ICMJE University of Nove de Julho
Collaborators  ICMJE Santa Casa de Misericórdia de Porto Alegre
Investigators  ICMJE Not Provided
PRS Account University of Nove de Julho
Verification Date April 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP