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Primary Prevention of Infection by COVID-19 in Workers

NCT04420260 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 152

Last updated 2021-07-15

No results posted yet for this study

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

Interventions

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.

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

Sponsors & Collaborators

  • Universidad de Antioquia

    collaborator OTHER

  • Unidad de Investigación Genética Molecular

    lead NETWORK

Principal Investigators

  • Beatriz H Aristizabal, PhD · Unidad de Investigación Genética Molecular

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-03-18
Primary Completion
2021-06-23
Completion
2021-07-05

Countries

  • Colombia

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04420260 on ClinicalTrials.gov