APT™ T3X on the COVID-19 Contamination Rate

NCT04716426 | Completed Results

• 1 other identifier: 4.485.847
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19

Keywords

Prevention; Tetracycline hydrochloride; COVID-19

Outcome Measures

Primary Outcomes (1)

• COVID-19 Contamination Rate.

  Rate of how many people were infected with COVID-19 over the course of the study in each group.

  22 days after randomization.

Secondary Outcomes (4)

• Number of Participants With Adverse Events

  22 days after randomization.

• Average Number of Adverse Events

  22 days after randomization.

• Days Over Which an Adverse Event Was Reported

  22 days after randomization.

• Other Virus or Bacteria Contamination Rate.

  22 days after randomization.

Study Arms (2)

Tetracycline hydrochloride 3%

EXPERIMENTAL

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.

Drug: Tetracycline hydrochloride 3%

Placebo

PLACEBO COMPARATOR

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.

Drug: Placebo

Interventions

Tetracycline hydrochloride 3% DRUG

Proprietary formulation composed of FDA approved inactive ingredients and the active pharmaceutical ingredient tetracycline hydrochloride.

Also known as: APT™T3X

Tetracycline hydrochloride 3%

Placebo DRUG

Formulation composed of FDA approved inactive ingredients.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Nove de Julho: lead
• Santa Casa de Porto Alegre: collaborator

Study Sites (1)

Santa Casa de Misericórdia de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90035-074, Brazil

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Ernesto Cesar Pinto Leal Junior
• Organization: ELJ Consultancy

ceo@eljconsultancy.com

+55 11 975222856

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full professor

Study Record Dates

• First Submitted: January 18, 2021
• First Posted: January 20, 2021
• Study Start: January 28, 2021
• Primary Completion: March 25, 2021
• Study Completion: March 25, 2021
• Last Updated: April 8, 2021
• Results First Posted: April 8, 2021

Record last verified: 2021-04

Locations

BR (1)