Primary Prevention of Infection by COVID-19 in Workers (PI-Covid-19)
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ClinicalTrials.gov Identifier: NCT04420260 |
Recruitment Status :
Completed
First Posted : June 9, 2020
Last Update Posted : July 15, 2021
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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.
Condition or disease | Intervention/treatment | Phase |
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COVID | Dietary Supplement: Group A: oropharygeal spray and immunostimulant emulsion Dietary Supplement: Group D:Placebo oropharyngeal spray + Placebo taken PO | Not Applicable |

Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 152 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 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) |
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 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. |
Primary Purpose: | Prevention |
Official Title: | Scheme of Primary Prevention of Infection by COVID-19, in Workers: Phase II Controlled Clinical Trial, to be Carried Out in Medellín-Antioquia |
Actual Study Start Date : | March 18, 2021 |
Actual Primary Completion Date : | June 23, 2021 |
Actual Study Completion Date : | July 5, 2021 |

Arm | Intervention/treatment |
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Experimental: Treatment oropharyngeal spray + immunostimulant emulsion
Active principle oropharyngeal spray + Active principle immunostimulant taken PO.
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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. Other Name: BLOCKACE2 (oropharyngeal spray) + BLOCKACE2 Emulsion (Active principle immunostimulant ) |
Placebo Comparator: Placebo
Placebo oropharyngeal spray + Placebo emulsion was taken PO.
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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 Other Name: Placebo+ Placebo |
- 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.
- Seroconversion of IgG for COVID-19. [ Time Frame: through study completion, 45 days ]seroconversion of IgG

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Ages Eligible for Study: | 18 Years to 60 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.

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
Colombia | |
Beatriz Aristizabal | |
Medellin, Antioquia, Colombia, 050021 |
Principal Investigator: | Beatriz H Aristizabal, PhD | Unidad de Investigación Genética Molecular |
Other Publications:
Responsible Party: | Beatriz 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: | July 15, 2021 |
Last Verified: | July 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
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 |
Coronavirus Infections, Spike Glycoprotein, Functional Food, Triple Blind Clinical Study,Efficacy-Effectiveness of Interventions |
Infections Adjuvants, Immunologic Immunologic Factors Physiological Effects of Drugs |