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

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ClinicalTrials.gov Identifier: NCT04420260
Recruitment Status : Not yet recruiting
First Posted : June 9, 2020
Last Update Posted : June 9, 2020
Sponsor:
Collaborator:
Universidad de Antioquia
Information provided by (Responsible Party):
Clara Ines Aristizabal, Unidad de Investigación Genética Molecular

Study Description
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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 capture 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 four study groups to compare the active compounds (oropharyngeal spray and capsule) with placebo.

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


Condition or disease Intervention/treatment Phase
COVID Dietary Supplement: Group A: oropharygeal spray and immunostimulant Dietary Supplement: Group B: Placebo oropharyngeal spray + Active principle immunostimulant Dietary Supplement: Group C:Active principle oropharyngeal spray + Placebo taken PO Dietary Supplement: Group D:Placebo oropharyngeal spray + Placebo taken PO Not Applicable

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Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
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 healthcare providers in Medellín-Antioquia. 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 healthcare providers in Medellín-Antioquia. Randomized clinical trial, parallel design, triple-blind, phase II.

A four arm RCT is stipulated, in the following manner:

Group A: Active principle spray + Active principle capsules. Group B: Placebo spray + Active principle capsules. Group C: Active principle spray + Placebo capsules. Group D: Placebo spray + Placebo capsules.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: 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 concern 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.
Primary Purpose: Prevention
Official Title: Scheme of Primary Prevention of Infection by COVID-19, in Health Providers: Phase II Controlled Clinical Trial, to be Carried Out in Medellín-Antioquia
Estimated Study Start Date : July 2020
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : September 2020
Arms and Interventions
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Arm Intervention/treatment
Experimental: Treatment oropharyngeal spray + immunostimulan
Active principle oropharyngeal spray + Active principle immunostimulant taken PO.
 Dietary Supplement: Group A: oropharygeal spray and immunostimulant

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

Intervention 2. Preparation in a solid pharmaceutical presentation for oral administration in a capsule form (inside a small gelatin container), that contains the bioactive compounds that have demonstrated modulation of the inflammatory response recognized at the moment in the immune activation against the virus.

Other Name: BLOCKACE (oropharyngeal spray) + ACECOVID (Active principle immunostimulant )
Experimental: Treatment immunostimulan

Placebo oropharyngeal spray + Active principle immunostimulant taken PO.

Placebo oropharyngeal spray + Placebo taken PO.

 Dietary Supplement: Group B: Placebo oropharyngeal spray + Active principle immunostimulant

Preparation in a liquid solution to be used for oropharyngeal spray, composed of placebo substances of routine use in humans.

Intervention 2. Preparation in a solid pharmaceutical presentation for oral administration in a capsule form (inside a small gelatin container), that contains the bioactive compounds that have demonstrated modulation of the inflammatory response recognized at the moment in the immune activation against the virus.

Other Name: Placebo oropharyngeal spray +ACECOVID (Active principle immunostimulant )
Experimental: Treatment oropharyngeal spray
Active principle oropharyngeal spray + Placebo taken PO.
 Dietary Supplement: Group C:Active principle oropharyngeal spray + Placebo taken PO

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

Intervention 2. Preparation in a solid pharmaceutical presentation for oral administration in a capsule form (inside a small gelatin container), that contains the Placebo compounds

Other Name: BLOCKACE Active principle oropharyngeal spray + Placebo taken PO
Placebo Comparator: Placebo
Placebo oropharyngeal spray + Placebo 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 a solid pharmaceutical presentation for oral administration in a capsule form (inside a small gelatin container), that contains the Placebo compounds

Other Name: Placebo+ Placebo


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Seroconversion of IgG for COVID-19. [ Time Frame: through study completion, 45 days ]
    seroconversion of IgG


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04420260


Contacts
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Contact: Beatriz H Aristizabal, PhD 3104498719 beatriz.aristizabal@unigem.com.co
Contact: Clara I Aristizabal, CEO 5745401100 gerencia@unigem.com.co

Sponsors and Collaborators
Unidad de Investigación Genética Molecular
Universidad de Antioquia
Investigators
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Principal Investigator: Beatriz H Aristizabal, PhD Unidad de Investigación Genética Molecular
More Information
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Publications of Results:

Other Publications:
Koch S, Pong W, Editors. The count of companies developing vaccines for coronavirus rises 2020 [Internet]. Redwood: BioCentury; 2020 [cited 2020 Feb 16]. Available from: https://www.biocentury.com/article/304412

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Responsible Party: Clara Ines Aristizabal, Beatriz H Aristizabal B, MsC immunology, MsC Medical Genetics, PhD Molecular Biolgy, Scientific director of Unidad de Investigación Genética Molecular, Unidad de Investigación Genética Molecular
ClinicalTrials.gov Identifier: NCT04420260    
Other Study ID Numbers: UNIGEM PT-IC-02
First Posted: June 9, 2020    Key Record Dates
Last Update Posted: June 9, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Infection
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs