Primary Prevention of Infection by COVID-19 in Workers
Condition: COVID
MeSH terms: Infections
Study type: Interventional

Summary: 
      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.
    

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).
    

Intervention name(s): Group A: oropharygeal spray and immunostimulant emulsion; Group D:Placebo oropharyngeal spray + Placebo taken PO
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 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.; 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 intervention name(s): BLOCKACE2 (oropharyngeal spray) + BLOCKACE2 Emulsion (Active principle immunostimulant ); Placebo+ Placebo
Intervention MeSH terms: Adjuvants, Immunologic
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Combination of an oropharyngeal spray and an oral immunostimulant agent for the prevention of COVID-19 infection in workers in Medellín-Antioquia. The randomized clinical trial, parallel design, triple-blind, phase II.
Combination of an oropharyngeal spray and an oral immunostimulant agent for the prevention of COVID-19 infection in workers in Medellín-Antioquia. The randomized clinical trial, parallel design, triple-blind, phase II.
A two-arm is stipulated, in the following manner:
Group A: Active principle spray + Active principle emulsion. Group B: Placebo spray + Placebo emulsion.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Coronavirus Infections, Spike Glycoprotein, Functional Food, Triple Blind Clinical Study,Efficacy-Effectiveness of Interventions