Primary Prevention of Infection by COVID-19 in Workers

NCT04420260 | Completed DMC

• 1 other identifier: UNIGEM PT-IC-02
• Study Type: interventional
• Target: 152
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

COVID

Keywords

Coronavirus Infections, Spike Glycoprotein, Functional Food, Triple Blind Clinical Study,Efficacy-Effectiveness of Interventions

Outcome Measures

Primary Outcomes (1)

• Seroconversion of IgM for COVID-19.

  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 Outcomes (1)

• Seroconversion of IgG for COVID-19.

  through study completion, 45 days

Study Arms (2)

Treatment oropharyngeal spray + immunostimulant emulsion

EXPERIMENTAL

Active principle oropharyngeal spray + Active principle immunostimulant taken PO.

Dietary Supplement: Group A: oropharygeal spray and immunostimulant emulsion

Placebo

PLACEBO COMPARATOR

Placebo oropharyngeal spray + Placebo emulsion was taken PO.

Dietary Supplement: Group D:Placebo oropharyngeal spray + Placebo taken PO

Interventions

Group A: oropharygeal spray and immunostimulant emulsion DIETARY_SUPPLEMENT

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.

Also known as: BLOCKACE2 (oropharyngeal spray) + BLOCKACE2 Emulsion (Active principle immunostimulant )

Treatment oropharyngeal spray + immunostimulant emulsion

Group D:Placebo oropharyngeal spray + Placebo taken PO DIETARY_SUPPLEMENT

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

Also known as: Placebo+ Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Unidad de Investigación Genética Molecular: lead
• Universidad de Antioquia: collaborator

Study Sites (1)

Beatriz Aristizabal

Medellín, Antioquia, 050021, Colombia

Location

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MeSH Terms

Conditions

Coronavirus Infections

Interventions

Placebo Effect

Condition Hierarchy (Ancestors)

Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections

Intervention Hierarchy (Ancestors)

Effect Modifier, Epidemiologic; Epidemiologic Factors; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Beatriz H Aristizabal, PhD

  Unidad de Investigación Genética Molecular

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Once the participant has given its informed consent, and the research team has verified the fulfillment of the inclusion criteria, the prospect receives a text message, to be directed to the pharmaceutical service. The numbered scheme will be dispensed with the code of the intervention, following the order from the allocation listing, provided by the CTCC. The head of the pharmaceutical service will register the date and time of the first dose. He will provide indications for the use, handling, and conservation of the products. Warning signs and symptoms and instructions for communication with the research team to address any concerns the subject may have will be reviewed. He will remind the subject to avoid its damage or loss. He will give the participant instructions to return the container and surpluses of the products at the end of the trial (day 30), he will point out that they are for personal use only and that they cannot be shared.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Beatriz H Aristizabal B, MsC immunology, MsC Medical Genetics, PhD Molecular Biolgy, Scientific director of Unidad de Investigación Genética Molecular

Model Details: 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.

Study Record Dates

• First Submitted: May 25, 2020
• First Posted: June 9, 2020
• Study Start: March 18, 2021
• Primary Completion: June 23, 2021
• Study Completion: July 5, 2021
• Last Updated: July 15, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

CO (1)