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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

Tracking Information
First Submitted Date  ICMJE May 25, 2020
First Posted Date  ICMJE June 9, 2020
Last Update Posted Date June 9, 2020
Estimated Study Start Date  ICMJE July 2020
Estimated Primary Completion Date September 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 4, 2020)		 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: June 4, 2020)		 Seroconversion of IgG for COVID-19. [ Time Frame: through study completion, 45 days ]
seroconversion of IgG
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Primary Prevention of Infection by COVID-19 in Health Providers
Official Title  ICMJE Scheme of Primary Prevention of Infection by COVID-19, in Health Providers: Phase II Controlled Clinical Trial, to be Carried Out in Medellín-Antioquia
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.
Detailed Description

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

BENEFITS OF EACH INTERVENTION.

INTERVENTION 1: The compound for oropharyngeal spray made out of three bioactive substances combined that are: allicin, eugenol and quercetin, as soluble recruiters of the virus at its main entry point, the upper respiratory tract or oropharyngeal region. There, these substances, which have high molecular homology to the sites or epitopes of the ACE-2 receptor, will act as soluble receptor for the virus, and will be a preventive barrier for its entrance and contact with the native receptor, ACE-2; in this way, it is intended to reduce the possibility of infection by COVID-19, protecting at the level of the oropharyngeal mucosa from the direct inoculation of the virus.

INTERVENTION 2: The immunostimulant compound will be used to potentiate the immune response of the subject, measured by the reduction in the risk of infection, as a complement to the effect of the soluble substances, homologous to the ACE-2 receptor, administered by oropharyngeal spray.

RESEARCH HYPOTHESIS: In health care providers in the front line of care of suspicious cases or patients with COVID-19, the combined use of the interventions in question (oropharyngeal spray of a soluble compound that captures the virus, in addition to the ingestion of an immunostimulant compound), in comparison to the non-administration of either (Placebo), reduces the risk of infection with COVID-19, expressed as a negative result in IgM, IgG; and in those who undergo seroconversion, the greater proportion will have a mild to moderate clinical presentation.

PRIMARY OBJECTIVE: To establish the efficacy of the combined use of the oropharyngeal spray of a soluble compound that captures the virus, in addition to the ingestion of an immunostimulant compound, in comparison with placebo, on the reduction of the risk of infection with COVID, indicated by the negative result in the measurement of COVID-19 immunoglobulins by 30 days of starting the combined therapy. To establish the safety of the study products with evaluation of the expected and unexpected adverse events encountered during the treatment phase of the intervention (30 days since entering the project).

SECONDARY OBJECTIVE: To establish the efficacy of the combined use of the of the oropharyngeal spray of a soluble compound that captures the virus, in addition to the ingestion of an immunostimulant compound, in comparison with placebo, on the reduction of the risk of infection with COVID, indicated by the clinical response to the disease, defined in three variations, mild to moderate: onset of fever, myalgias and cough without dyspnea; severe: fever, myalgias, cough and dyspnea that requires inpatient care; and critical: all of the above in addition to ventilatory support in the ICU.

EXPLORATORY OBJECTIVES: To explore the efficacy of the combined use of the oropharyngeal spray of a soluble compound that captures the virus, in addition to the ingestion of an immunostimulant compound, on the reduction of the development of symptoms such as fever, cough, dyspnea, myalgias, or ventilatory support in the ICU, 15 days after finishing the treatment scheme. To explore the independent efficacy of each intervention (oropharyngeal spray of a soluble compound that captures the virus, or the ingestion of an immunostimulant compound), compared with placebo, on the reduction in the risk of infection with COVID, given by the negative result of IgG, IgM; and the decrease in the risk of symptoms such as fever, cough, dyspnea, myalgias, or ventilatory support in the ICU, 15 days after finishing the treatment scheme.

FIELD OF STUDY: Health care centers in the city of Medellín, where suspected cases and patients with COVID-19 are being treated. A list with the participating centers will be drawn up.

INTERVENTIONS.

ACTIVE PRINCIPLE:

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.

PLACEBO: Formulations without active components in the same pharmaceutical form as the former (intervention 1 and intervention 2). They will be presented with the same physical characteristics as the placebos, such as: shape, form, color, taste, smell, consistency, printed indications, weight, surface details, internal and external; in this way, the principal of concealment is guaranteed. They must be used under the following indications.

Intervention 1: Two oropharyngeal sprays of the compound, every 4 hours, during the day.

Intervention 2: Administering 1 capsule by mouth of the immunostimulant, every twelve hours. 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 (capsules). 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 in site. Each treatment scheme is labeled with a unique code that identifies it, and it contains: One (1) device for oropharyngeal spray, with capacity for 200 applications. One (1) bottle with 90 capsules (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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE COVID
Intervention  ICMJE
  • 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 )
  • 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 )
  • 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
  • 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
Study Arms  ICMJE
  • Experimental: Treatment oropharyngeal spray + immunostimulan
    Active principle oropharyngeal spray + Active principle immunostimulant taken PO.
    Intervention: Dietary Supplement: Group A: oropharygeal spray and immunostimulant
  • Experimental: Treatment immunostimulan

    Placebo oropharyngeal spray + Active principle immunostimulant taken PO.

    Placebo oropharyngeal spray + Placebo taken PO.

    Intervention: Dietary Supplement: Group B: Placebo oropharyngeal spray + Active principle immunostimulant
  • Experimental: Treatment oropharyngeal spray
    Active principle oropharyngeal spray + Placebo taken PO.
    Intervention: Dietary Supplement: Group C:Active principle oropharyngeal spray + Placebo taken PO
  • Placebo Comparator: Placebo
    Placebo oropharyngeal spray + Placebo taken PO.
    Intervention: Dietary Supplement: Group D:Placebo oropharyngeal spray + Placebo taken PO
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: June 4, 2020)		 300
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2020
Estimated Primary Completion Date September 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Beatriz H Aristizabal, PhD 3104498719 beatriz.aristizabal@unigem.com.co
Contact: Clara I Aristizabal, CEO 5745401100 gerencia@unigem.com.co
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04420260
Other Study ID Numbers  ICMJE UNIGEM PT-IC-02
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Clara Ines Aristizabal, Unidad de Investigación Genética Molecular
Study Sponsor  ICMJE Unidad de Investigación Genética Molecular
Collaborators  ICMJE Universidad de Antioquia
Investigators  ICMJE
Principal Investigator: Beatriz H Aristizabal, PhD Unidad de Investigación Genética Molecular
PRS Account Unidad de Investigación Genética Molecular
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP