COVID-19NCT04716426
APT™ T3X on the COVID-19 Contamination Rate
A study testing Tetracycline hydrochloride 3% in people with COVID-19, run by University of Nove de Julho at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- COVID-19
- What is being tested?
- Tetracycline hydrochloride 3%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteBrazil
- Study dates
- 28 Jan 2021to 25 Mar 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Santa Casa de Misericórdia de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035-074
About this study
Official title: Use of APT™ T3X to Decrease the COVID-19 Contamination Rate in Humans
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.
Read more
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.
Read the 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:
- COVID-19 contamination rate.
- Presence of adverse events.
- Number of adverse events.
- Frequency of adverse events.
- 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).
- Conditions
- COVID-19
- Being tested
- Tetracycline hydrochloride 3%, Placebo
- Keywords
- Prevention, Tetracycline hydrochloride, COVID-19
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tetracycline hydrochloride 3%Drug
Also called APT™T3X
Proprietary formulation composed of FDA approved inactive ingredients and the active pharmaceutical ingredient tetracycline hydrochloride.
PlaceboDrug
Formulation composed of FDA approved inactive ingredients.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
COVID-19 Contamination Rate.
Rate of how many people were infected with COVID-19 over the course of the study in each group.
Measured: 22 days after randomization.
Secondary outcomes (4)
Number of Participants With Adverse Events
Number of participants who presented adverse events.
Measured: 22 days after randomization.
Average Number of Adverse Events
Average number of adverse events over the course of the study.
Measured: 22 days after randomization.
Days Over Which an Adverse Event Was Reported
Average days over which an adverse event was reported.
Measured: 22 days after randomization.
Other Virus or Bacteria Contamination Rate.
Rate of how many people were infected with influenza or pneumonia over the course of the study in each group.
Measured: 22 days after randomization.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2021
- Study start28 Jan 2021
- Primary completion25 Mar 2021
- Study completion25 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nove de Julho
- Sponsor type
- University, hospital or other
- Collaborators
- Santa Casa de Porto Alegre
- Responsible party
- Principal investigator, Ernesto Cesar Pinto Leal Junior, University of Nove de Julho
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04716426
- Sponsor's protocol ID
- 4.485.847
- Status last verified
- Apr 2021
- First submitted
- 18 Jan 2021
- Last updated
- 8 Apr 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of APT™ T3X to Decrease the COVID-19 Contamination Rate in Humans
- ClinicalTrials.gov ID
- NCT04716426
- Acronym / sponsor ID
- 4.485.847
- Conditions
- COVID-19
- Keywords
- Prevention, Tetracycline hydrochloride, COVID-19
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of Nove de JulhoUniversity, hospital or other
- Collaborators
- Santa Casa de Porto Alegre
- Study start
- 28 Jan 2021 (actual)
- Primary completion
- 25 Mar 2021 (actual)
- Study completion
- 25 Mar 2021 (actual)
- First posted
- 20 Jan 2021 (actual)
- Results
- Posted 8 Apr 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- COVID-19 contamination rate.
- Presence of adverse events.
- Number of adverse events.
- Frequency of adverse events.
- 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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tetracycline hydrochloride 3% | Experimental | Drug: 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. |
| Placebo | Placebo comparator | Drug: Placebo4 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tetracycline hydrochloride 3%Also: APT™T3XProprietary formulation composed of FDA approved inactive ingredients and the active pharmaceutical ingredient tetracycline hydrochloride. | Drug | Tetracycline hydrochloride 3% |
| PlaceboFormulation composed of FDA approved inactive ingredients. | Drug | Placebo |
Primary outcome
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.
4 secondary outcomes
Number of Participants With Adverse Events
Time frame: 22 days after randomization.
Average Number of Adverse Events
Time frame: 22 days after randomization.
Days Over Which an Adverse Event Was Reported
Time frame: 22 days after randomization.
Other Virus or Bacteria Contamination Rate.
Time frame: 22 days after randomization.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tetracycline hydrochloride 3% in people with COVID-19, run by University of Nove de Julho at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Apr 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
COVID-19 Contamination Rate. (time frame: 22 days after randomization.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2021.