Primary Prevention of Infection by COVID-19 in Workers (PI-Covid-19)

July 8, 2021 updated by: Beatriz Aristizabal, Unidad de Investigación Genética Molecular

Scheme of Primary Prevention of Infection by COVID-19, in Workers: Phase II Controlled Clinical Trial, to be Carried Out in Medellín-Antioquia

Introduction: The SARS Co-2 contagious rate is high (Ro: 2.0-3.0). The infection is aggressive with high pathogenicity. Global confinement impacts all social and economic fields of human activity. Clinical behavior exceeds the capabilities of public health care. With the initial information on the pandemic, it is estimated that 20% of health personnel in direct contact with patients can acquire the disease, despite preventive self-care. The molecular relationship of COVID-19 with the subject's ACE2 protein encourages the virus to enter the host cell, and initiates replication and the immune response, causing an imbalance generating an immunological storm of cytokines, with serious damage to the host.

Objective: It is proposed to supply a combined scheme of two compounds by oropharyngeal spray that captures the virus before entering the target cell and orally administer immunomodulatory compounds that regulate the inflammatory response released by the virus, in order to improve the antiviral response.

Methodology: A controlled, parallel design, triple-blind, phase II clinical trial will be conducted with two study groups to compare the active compounds (oropharyngeal spray and emulsion) with placebo.

Discussion: With the application of the combined scheme of two compounds, a 75% reduction in infection is expected for workers in direct contact with COVID patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

RESEARCH QUESTION: Can the oropharyngeal spray of a viral blocking compound in conjunction with the provision of an immunostimulant emulsion, reduce the infection proportion by 2/3

ACTIVE PRINCIPLE Intervention 1. BlockACE2® spray, antimicrobial and antiviral liquid solution for mouth spray, composed of 3 natural bioactive substances proven to be used in humans, which present molecular structures homologous to the native receptor of the virus. It contains binding peptides that resemble the ACE2 receptor, which bind to viral fractions, and acts as soluble scavengers of the virus at the entrance gate, upper respiratory tract, or oropharyngeal region, preventing its entry into the target cell and decreasing the amount of virus that enters the body; consequently, they reduce their ability to generate damage.

BlockACE2® Defense, food for oral administration in the form of an emulsion with 8 bioactive components that have shown modulation of the inflammatory response. Contains natural oils, Vitamin B6, Vitamin C, Vitamin E, Vitamin D3 100 SD / S, and minerals; key micronutrients that are not normally obtained through a traditional diet. These nutrients are immunostimulants with proven capacity to enhance the cellular response against viruses, anti-inflammatory, antioxidant, and chemoprotective activity, stimulating the production of interferon I; and as a whole, they prevent the generation of an excessive immune activation process, known as an "immune storm" mediated by pro-inflammatory cytokines.

Intervention 2, Placebo:

Preparations without active components in the pharmaceutical form of the above (Intervention 1 and Intervention 2). They will be presented with the same physical characteristics such as size, shape, color, taste, smell, consistency, printed signs, weight, surface finish, internal and external; in order to guarantee the principle of masking.

RESEARCH HYPOTHESIS:

In a population with community risk of COVID-19 infection, the combined use of the study interventions (the oral antimicrobial solution in Spray BlockACE2® and the food in BlockACE2® emulsion, compared to the use of Placebo, reduces the risk of COVID-19 infection expressed in a negative PCR result in those who seroconvert to IgM, and in those who seroconvert, the higher proportion will be in the mild-moderate clinical form.

PRIMARY OBJECTIVE To establish the efficacy of the combined use of BlockACE2® oropharyngeal spray, and BlockACE2® emulsion, in comparison with placebo on the reduction of the risk of infection by COVID-19, expressed in the negative result of immunoglobulins for COVID-19 (30 days from admission to the project).

Establish the safety of the products under study by evaluating the expected and unexpected adverse events that are recorded during the use phase of the intervention scheme (30 days from project entry).

SECONDARY OBJECTIVE To establish the efficacy of the combined use of BlockACE2® spray, a soluble virus scavenger compound plus ingestion of BlockACE2® emulsion, a compound that improves the defenses of the immune system, compared to placebo, on reducing the risk of infection by COVID-19 expressed in the clinical response of the disease that is defined in three variables, mild to moderate: onset of fever, myalgia, and cough without dyspnea; severe: fever, myalgia, cough and dyspnea requiring hospital care; and critical: all the above plus ventilatory assistance in ICU.

EXPLORATORY OBJECTIVES Explore the efficacy of the combined use of BlockACE2® spray, a soluble virus scavenger compound, plus the intake of BlockACE2®, an emulsion food with key micronutrients that stimulate the antiviral cellular immune response on reducing the risk of COVID-19 infection expressed in the negative result of IgG, IgM; and the reduction of the risk of symptoms such as fever, cough, dyspnea, myalgia, or ventilatory assistance in the ICU after 15 days of finishing the scheme.

FIELD OF STUDY: Workers of every department of Conconcreto Company in the city of Medellín and Girardota

INTERVENTIONS:

Intervention 1 BLOCKACE2: Two oropharyngeal sprays of the compound, every 4 hours, during the day. For the BlockACE2 emulsion will be used 20 ml during the first 5 days and after it only 10ml every day for 30 days. Dosing of the substances in intervention 1 follows the described pharmacological characteristics, that guarantee its permanence in the oral mucosa to protect the entry pathway of the virus into the organism (Oropharynx). The dosage of the oral compounds was defined according to recommendations of the WHO for the modulation of the immune response (Emulsion).

Intervention 2 PLACEBO: spray and emulsion with similar color, smell, and texture but without the natural active compounds.

In the randomization visit V1, each participant will be assigned a treatment scheme, composed of intervention 1 and intervention 2, in sufficient quantity for the duration of the study. The pharmaceutical service will dispense the code of the scheme, following a sequential order, indicated in an allocation listing of the schemes on site. Each treatment scheme is labeled with a unique code that identifies it, and it contains One (1) device for oropharyngeal spray, with a capacity for 200 applications. One (1) bottle with 360 ml (oral). In the subsequent visits, the adherence to the dispensed schemes will be verified. The frequency of use will be checked, and dosing omissions will be registered by frequency (1 dose, once a week, more than once a week).

Study Type

Interventional

Enrollment (Actual)

152

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Colombia
    • Antioquia
      • Medellin, Antioquia, Colombia, 050021
        • Beatriz Aristizabal

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 58 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Age between 18 and 60 years.
  2. Health care worker in the front line of care of suspected or confirmed cases of COVID-19.
  3. Negative IgM antibodies.

Exclusion Criteria:

  1. Being a participant in another trial with another drug.
  2. Temperature above 38ºC.
  3. Having cohabited in the past 15 days with a person diagnosed with CoV-19.
  4. Pregnancy.
  5. Active o past smoker.
  6. Known hypersensitivity to drugs or food.
  7. History of respiratory disease.
  8. Underlying diseases (Hypertension, cancer, diabetes, cardiovascular disease, leukopenia).
  9. Signs or symptoms of CoV-19 infection: cough, dyspnea, myalgias.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment oropharyngeal spray + immunostimulant emulsion
Active principle oropharyngeal spray + Active principle immunostimulant taken PO.
Dietary supplement: Group A: oropharygeal spray and immunostimulant emulsion

Intervention 1: Preparation in a liquid solution to be used for oropharyngeal spray, composed of 3 natural bioactive substances of routine use in humans, that feature homologous molecular structures to the native viral receptor.

Intervention 2. Preparation in an emulsion functional food presentation for oral administration, that contains the 8 bioactive compounds that have demonstrated antiviral activity and modulation of the inflammatory response recognized at the moment in the immune activation against the virus.

Other Names:
  • BLOCKACE2 (oropharyngeal spray) + BLOCKACE2 Emulsion (Active principle immunostimulant )
Placebo Comparator: Placebo
Placebo oropharyngeal spray + Placebo emulsion was taken PO.
Dietary supplement: Group D:Placebo oropharyngeal spray + Placebo taken PO

Intervention 1: Preparation in a liquid solution to be used for oropharyngeal spray, composed of Placebo substances of routine use in humans.

Intervention 2. Preparation in an emulsion presentation for oral administration that contains the Placebo compounds

Other Names:
  • Placebo+ Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Seroconversion of IgM for COVID-19.
Time Frame: 1 month
Seroconversion of IgM for COVID-19. Result of positive IgM antibodies: A previously scheduled closure visit will be conducted, the trial product will be interrupted if a case is classified as severe-critical, and clinical follow up will be continued as planned. As protocols by the Health Ministry dictate, cases will be confirmed with a PCR-RT test, for the diagnosis of COVID-19. The result of the test will be requested to document the outcome.
1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Seroconversion of IgG for COVID-19.
Time Frame: through study completion, 45 days
seroconversion of IgG
through study completion, 45 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Unidad de Investigación Genética Molecular

Collaborators

Universidad de Antioquia

Investigators

  • Principal Investigator: Beatriz H Aristizabal, PhD, Unidad de Investigación Genética Molecular

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 18, 2021

Primary Completion (Actual)

June 23, 2021

Study Completion (Actual)

July 5, 2021

Study Registration Dates

First Submitted

May 25, 2020

First Submitted That Met QC Criteria

June 4, 2020

First Posted (Actual)

June 9, 2020

Study Record Updates

Last Update Posted (Actual)

July 15, 2021

Last Update Submitted That Met QC Criteria

July 8, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UNIGEM PT-IC-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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