COVIDPI-Covid-19NCT04420260
Primary Prevention of Infection by COVID-19 in Workers
A study testing Group A: oropharygeal spray and immunostimulant emulsion in people with COVID, run by Unidad de Investigación Genética Molecular at 1 site in Colombia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- COVID
- What is being tested?
- Group A: oropharygeal spray and immunostimulant emulsion
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 152 participants
- Where
- 1 siteColombia
- Study dates
- 18 Mar 2021to 5 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 9Show fewer
- History of respiratory disease.
- Underlying diseases (Hypertension, cancer, diabetes, cardiovascular disease, leukopenia).
- Signs or symptoms of CoV-19 infection: cough, dyspnea, myalgias.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read more
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.
Read the detailed description
RESEARCH QUESTION: Can the oropharyngeal spray of a viral blocking compound in conjunction with the provision of an immunostimulant emulsion, reduce the infection proportion by 2/3
ACTIVE PRINCIPLE Intervention 1. BlockACE2® spray, antimicrobial and antiviral liquid solution for mouth spray, composed of 3 natural bioactive substances proven to be used in humans, which present molecular structures homologous to the native receptor of the virus. It contains binding peptides that resemble the ACE2 receptor, which bind to viral fractions, and acts as soluble scavengers of the virus at the entrance gate, upper respiratory tract, or oropharyngeal region, preventing its entry into the target cell and decreasing the amount of virus that enters the body; consequently, they reduce their ability to generate damage.
BlockACE2® Defense, food for oral administration in the form of an emulsion with 8 bioactive components that have shown modulation of the inflammatory response. Contains natural oils, Vitamin B6, Vitamin C, Vitamin E, Vitamin D3 100 SD / S, and minerals; key micronutrients that are not normally obtained through a traditional diet. These nutrients are immunostimulants with proven capacity to enhance the cellular response against viruses, anti-inflammatory, antioxidant, and chemoprotective activity, stimulating the production of interferon I; and as a whole, they prevent the generation of an excessive immune activation process, known as an "immune storm" mediated by pro-inflammatory cytokines.
Intervention 2, Placebo:
Preparations without active components in the pharmaceutical form of the above (Intervention 1 and Intervention 2). They will be presented with the same physical characteristics such as size, shape, color, taste, smell, consistency, printed signs, weight, surface finish, internal and external; in order to guarantee the principle of masking.
RESEARCH HYPOTHESIS:
In a population with community risk of COVID-19 infection, the combined use of the study interventions (the oral antimicrobial solution in Spray BlockACE2® and the food in BlockACE2® emulsion, compared to the use of Placebo, reduces the risk of COVID-19 infection expressed in a negative PCR result in those who seroconvert to IgM, and in those who seroconvert, the higher proportion will be in the mild-moderate clinical form.
PRIMARY OBJECTIVE To establish the efficacy of the combined use of BlockACE2® oropharyngeal spray, and BlockACE2® emulsion, in comparison with placebo on the reduction of the risk of infection by COVID-19, expressed in the negative result of immunoglobulins for COVID-19 (30 days from admission to the project).
Establish the safety of the products under study by evaluating the expected and unexpected adverse events that are recorded during the use phase of the intervention scheme (30 days from project entry).
SECONDARY OBJECTIVE To establish the efficacy of the combined use of BlockACE2® spray, a soluble virus scavenger compound plus ingestion of BlockACE2® emulsion, a compound that improves the defenses of the immune system, compared to placebo, on reducing the risk of infection by COVID-19 expressed in the clinical response of the disease that is defined in three variables, mild to moderate: onset of fever, myalgia, and cough without dyspnea; severe: fever, myalgia, cough and dyspnea requiring hospital care; and critical: all the above plus ventilatory assistance in ICU.
EXPLORATORY OBJECTIVES Explore the efficacy of the combined use of BlockACE2® spray, a soluble virus scavenger compound, plus the intake of BlockACE2®, an emulsion food with key micronutrients that stimulate the antiviral cellular immune response on reducing the risk of COVID-19 infection expressed in the negative result of IgG, IgM; and the reduction of the risk of symptoms such as fever, cough, dyspnea, myalgia, or ventilatory assistance in the ICU after 15 days of finishing the scheme.
FIELD OF STUDY: Workers of every department of Conconcreto Company in the city of Medellín and Girardota
INTERVENTIONS:
Intervention 1 BLOCKACE2: Two oropharyngeal sprays of the compound, every 4 hours, during the day. For the BlockACE2 emulsion will be used 20 ml during the first 5 days and after it only 10ml every day for 30 days. 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 (Emulsion).
Intervention 2 PLACEBO: spray and emulsion with similar color, smell, and texture but without the natural active compounds.
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 on site. Each treatment scheme is labeled with a unique code that identifies it, and it contains One (1) device for oropharyngeal spray, with a capacity for 200 applications. One (1) bottle with 360 ml (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).
- Conditions
- COVID
- Being tested
- Group A: oropharygeal spray and immunostimulant emulsion, Group D:Placebo oropharyngeal spray + Placebo taken PO
- Keywords
- Coronavirus Infections, Spike Glycoprotein, Functional Food, Triple Blind Clinical Study,Efficacy-Effectiveness of Interventions
- Medical subject headings
- Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group A: oropharygeal spray and immunostimulant emulsionDietary supplement
Also called BLOCKACE2 (oropharyngeal spray) + BLOCKACE2 Emulsion (Active principle immunostimulant )
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.
Group D:Placebo oropharyngeal spray + Placebo taken PODietary supplement
Also called Placebo+ Placebo
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
| Study group | Role | What they receive |
|---|---|---|
| Treatment oropharyngeal spray + immunostimulant emulsion | Experimental | Active principle oropharyngeal spray + Active principle immunostimulant taken PO. Receives: Dietary Supplement: Group A: oropharygeal spray and immunostimulant emulsion |
| Placebo | Placebo comparator | Placebo oropharyngeal spray + Placebo emulsion was taken PO. Receives: Dietary Supplement: Group D:Placebo oropharyngeal spray + Placebo taken PO |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 month
Secondary outcomes (1)
Seroconversion of IgG for COVID-19.
seroconversion of IgG
Measured: through study completion, 45 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2020
- Study start18 Mar 2021
- Primary completion23 Jun 2021
- Study completion5 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (131)Papers the sponsor has linked to this study.
- Other trials for COVIDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 152 participants (actual)
Sponsor and investigators
- Lead sponsor
- Unidad de Investigación Genética Molecular
- Sponsor type
- Research network
- Collaborators
- Universidad de Antioquia
- Responsible party
- Principal investigator, Beatriz Aristizabal, Unidad de Investigación Genética Molecular
- Investigators
- Beatriz H Aristizabal, PhD, Principal investigator, Unidad de Investigación Genética Molecular
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04420260
- Sponsor's protocol ID
- UNIGEM PT-IC-02
- Acronym
- PI-Covid-19
- Status last verified
- Jul 2021
- First submitted
- 25 May 2020
- Last updated
- 15 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yong CY, Ong HK, Yeap SK, Ho KL, Tan WS. Recent Advances in the Vaccine Development Against Middle East Respiratory Syndrome-Coronavirus. Front Microbiol. 2019 Aug 2;10:1781. doi: 10.3389/fmicb.2019.01781. eCollection 2019.
PubMed 31428074Song Z, Xu Y, Bao L, Zhang L, Yu P, Qu Y, Zhu H, Zhao W, Han Y, Qin C. From SARS to MERS, Thrusting Coronaviruses into the Spotlight. Viruses. 2019 Jan 14;11(1):59. doi: 10.3390/v11010059.
PubMed 30646565Thomas SJ, L'Azou M, Barrett AD, Jackson NA. Fast-Track Zika Vaccine Development - Is It Possible? N Engl J Med. 2016 Sep 29;375(13):1212-6. doi: 10.1056/NEJMp1609300. No abstract available.
PubMed 27682032Koch 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
Ma-Lauer Y, Zheng Y, Malesevic M, von Brunn B, Fischer G, von Brunn A. Influences of cyclosporin A and non-immunosuppressive derivatives on cellular cyclophilins and viral nucleocapsid protein during human coronavirus 229E replication. Antiviral Res. 2020 Jan;173:104620. doi: 10.1016/j.antiviral.2019.104620. Epub 2019 Oct 18.
PubMed 31634494Shakya A, Bhat HR, Ghosh SK. Update on Nitazoxanide: A Multifunctional Chemotherapeutic Agent. Curr Drug Discov Technol. 2018;15(3):201-213. doi: 10.2174/1570163814666170727130003.
PubMed 28748751Pervushin K, Tan E, Parthasarathy K, Lin X, Jiang FL, Yu D, Vararattanavech A, Soong TW, Liu DX, Torres J. Structure and inhibition of the SARS coronavirus envelope protein ion channel. PLoS Pathog. 2009 Jul;5(7):e1000511. doi: 10.1371/journal.ppat.1000511. Epub 2009 Jul 10.
PubMed 19593379Barton C, Kouokam JC, Lasnik AB, Foreman O, Cambon A, Brock G, Montefiori DC, Vojdani F, McCormick AA, O'Keefe BR, Palmer KE. Activity of and effect of subcutaneous treatment with the broad-spectrum antiviral lectin griffithsin in two laboratory rodent models. Antimicrob Agents Chemother. 2014;58(1):120-7. doi: 10.1128/AAC.01407-13. Epub 2013 Oct 21.
PubMed 24145548Pruijssers AJ, Denison MR. Nucleoside analogues for the treatment of coronavirus infections. Curr Opin Virol. 2019 Apr;35:57-62. doi: 10.1016/j.coviro.2019.04.002. Epub 2019 May 21.
PubMed 31125806Totura AL, Bavari S. Broad-spectrum coronavirus antiviral drug discovery. Expert Opin Drug Discov. 2019 Apr;14(4):397-412. doi: 10.1080/17460441.2019.1581171. Epub 2019 Mar 8.
PubMed 30849247Mielech AM, Kilianski A, Baez-Santos YM, Mesecar AD, Baker SC. MERS-CoV papain-like protease has deISGylating and deubiquitinating activities. Virology. 2014 Feb;450-451:64-70. doi: 10.1016/j.virol.2013.11.040. Epub 2013 Dec 22.
PubMed 24503068Momattin H, Al-Ali AY, Al-Tawfiq JA. A Systematic Review of therapeutic agents for the treatment of the Middle East Respiratory Syndrome Coronavirus (MERS-CoV). Travel Med Infect Dis. 2019 Jul-Aug;30:9-18. doi: 10.1016/j.tmaid.2019.06.012. Epub 2019 Jun 25.
PubMed 31252170Sutton TC, Subbarao K. Development of animal models against emerging coronaviruses: From SARS to MERS coronavirus. Virology. 2015 May;479-480:247-58. doi: 10.1016/j.virol.2015.02.030. Epub 2015 Mar 16.
PubMed 25791336Mubarak A, Alturaiki W, Hemida MG. Middle East Respiratory Syndrome Coronavirus (MERS-CoV): Infection, Immunological Response, and Vaccine Development. J Immunol Res. 2019 Apr 7;2019:6491738. doi: 10.1155/2019/6491738. eCollection 2019.
PubMed 31089478Wiley JA, Richert LE, Swain SD, Harmsen A, Barnard DL, Randall TD, Jutila M, Douglas T, Broomell C, Young M, Harmsen A. Inducible bronchus-associated lymphoid tissue elicited by a protein cage nanoparticle enhances protection in mice against diverse respiratory viruses. PLoS One. 2009 Sep 23;4(9):e7142. doi: 10.1371/journal.pone.0007142.
PubMed 19774076
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04420260
- Acronym / sponsor ID
- PI-Covid-19 / UNIGEM PT-IC-02
- Conditions
- COVID
- Keywords
- Coronavirus Infections, Spike Glycoprotein, Functional Food, Triple Blind Clinical Study,Efficacy-Effectiveness of Interventions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 152 participants (actual)
- Lead sponsor
- Unidad de Investigación Genética MolecularResearch network
- Collaborators
- Universidad de Antioquia
- Study start
- 18 Mar 2021 (actual)
- Primary completion
- 23 Jun 2021 (actual)
- Study completion
- 5 Jul 2021 (actual)
- First posted
- 9 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
RESEARCH QUESTION: Can the oropharyngeal spray of a viral blocking compound in conjunction with the provision of an immunostimulant emulsion, reduce the infection proportion by 2/3
ACTIVE PRINCIPLE Intervention 1. BlockACE2® spray, antimicrobial and antiviral liquid solution for mouth spray, composed of 3 natural bioactive substances proven to be used in humans, which present molecular structures homologous to the native receptor of the virus. It contains binding peptides that resemble the ACE2 receptor, which bind to viral fractions, and acts as soluble scavengers of the virus at the entrance gate, upper respiratory tract, or oropharyngeal region, preventing its entry into the target cell and decreasing the amount of virus that enters the body; consequently, they reduce their ability to generate damage.
BlockACE2® Defense, food for oral administration in the form of an emulsion with 8 bioactive components that have shown modulation of the inflammatory response. Contains natural oils, Vitamin B6, Vitamin C, Vitamin E, Vitamin D3 100 SD / S, and minerals; key micronutrients that are not normally obtained through a traditional diet. These nutrients are immunostimulants with proven capacity to enhance the cellular response against viruses, anti-inflammatory, antioxidant, and chemoprotective activity, stimulating the production of interferon I; and as a whole, they prevent the generation of an excessive immune activation process, known as an "immune storm" mediated by pro-inflammatory cytokines.
Intervention 2, Placebo:
Preparations without active components in the pharmaceutical form of the above (Intervention 1 and Intervention 2). They will be presented with the same physical characteristics such as size, shape, color, taste, smell, consistency, printed signs, weight, surface finish, internal and external; in order to guarantee the principle of masking.
RESEARCH HYPOTHESIS:
In a population with community risk of COVID-19 infection, the combined use of the study interventions (the oral antimicrobial solution in Spray BlockACE2® and the food in BlockACE2® emulsion, compared to the use of Placebo, reduces the risk of COVID-19 infection expressed in a negative PCR result in those who seroconvert to IgM, and in those who seroconvert, the higher proportion will be in the mild-moderate clinical form.
PRIMARY OBJECTIVE To establish the efficacy of the combined use of BlockACE2® oropharyngeal spray, and BlockACE2® emulsion, in comparison with placebo on the reduction of the risk of infection by COVID-19, expressed in the negative result of immunoglobulins for COVID-19 (30 days from admission to the project).
Establish the safety of the products under study by evaluating the expected and unexpected adverse events that are recorded during the use phase of the intervention scheme (30 days from project entry).
SECONDARY OBJECTIVE To establish the efficacy of the combined use of BlockACE2® spray, a soluble virus scavenger compound plus ingestion of BlockACE2® emulsion, a compound that improves the defenses of the immune system, compared to placebo, on reducing the risk of infection by COVID-19 expressed in the clinical response of the disease that is defined in three variables, mild to moderate: onset of fever, myalgia, and cough without dyspnea; severe: fever, myalgia, cough and dyspnea requiring hospital care; and critical: all the above plus ventilatory assistance in ICU.
EXPLORATORY OBJECTIVES Explore the efficacy of the combined use of BlockACE2® spray, a soluble virus scavenger compound, plus the intake of BlockACE2®, an emulsion food with key micronutrients that stimulate the antiviral cellular immune response on reducing the risk of COVID-19 infection expressed in the negative result of IgG, IgM; and the reduction of the risk of symptoms such as fever, cough, dyspnea, myalgia, or ventilatory assistance in the ICU after 15 days of finishing the scheme.
FIELD OF STUDY: Workers of every department of Conconcreto Company in the city of Medellín and Girardota
INTERVENTIONS:
Intervention 1 BLOCKACE2: Two oropharyngeal sprays of the compound, every 4 hours, during the day. For the BlockACE2 emulsion will be used 20 ml during the first 5 days and after it only 10ml every day for 30 days. 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 (Emulsion).
Intervention 2 PLACEBO: spray and emulsion with similar color, smell, and texture but without the natural active compounds.
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 on site. Each treatment scheme is labeled with a unique code that identifies it, and it contains One (1) device for oropharyngeal spray, with a capacity for 200 applications. One (1) bottle with 360 ml (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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Treatment oropharyngeal spray + immunostimulant emulsion | Experimental | Dietary Supplement: Group A: oropharygeal spray and immunostimulant emulsionActive principle oropharyngeal spray + Active principle immunostimulant taken PO. |
| Placebo | Placebo comparator | Dietary Supplement: Group D:Placebo oropharyngeal spray + Placebo taken POPlacebo oropharyngeal spray + Placebo emulsion was taken PO. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group A: oropharygeal spray and immunostimulant emulsionAlso: BLOCKACE2 (oropharyngeal spray) + BLOCKACE2 Emulsion (Active principle immunostimulant )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 | Treatment oropharyngeal spray + immunostimulant emulsion |
| Group D:Placebo oropharyngeal spray + Placebo taken POAlso: Placebo+ PlaceboIntervention 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 | Dietary supplement | Placebo |
Primary outcome
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.
1 secondary outcome
Seroconversion of IgG for COVID-19.
Time frame: through study completion, 45 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2021.
- Background: PubMed 31428074Yong CY, Ong HK, Yeap SK, Ho KL, Tan WS. Recent Advances in the Vaccine Development Against Middle East Respiratory Syndrome-Coronavirus. Front Microbiol. 2019 Aug 2;10:1781. doi: 10.3389/fmicb.2019.01781. eCollection 2019.
- Background: PubMed 30646565Song Z, Xu Y, Bao L, Zhang L, Yu P, Qu Y, Zhu H, Zhao W, Han Y, Qin C. From SARS to MERS, Thrusting Coronaviruses into the Spotlight. Viruses. 2019 Jan 14;11(1):59. doi: 10.3390/v11010059.
- Background: PubMed 27682032Thomas SJ, L'Azou M, Barrett AD, Jackson NA. Fast-Track Zika Vaccine Development - Is It Possible? N Engl J Med. 2016 Sep 29;375(13):1212-6. doi: 10.1056/NEJMp1609300. No abstract available.
- BackgroundKoch 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
- Background: PubMed 31634494Ma-Lauer Y, Zheng Y, Malesevic M, von Brunn B, Fischer G, von Brunn A. Influences of cyclosporin A and non-immunosuppressive derivatives on cellular cyclophilins and viral nucleocapsid protein during human coronavirus 229E replication. Antiviral Res. 2020 Jan;173:104620. doi: 10.1016/j.antiviral.2019.104620. Epub 2019 Oct 18.
- Background: PubMed 28748751Shakya A, Bhat HR, Ghosh SK. Update on Nitazoxanide: A Multifunctional Chemotherapeutic Agent. Curr Drug Discov Technol. 2018;15(3):201-213. doi: 10.2174/1570163814666170727130003.
- Background: PubMed 19593379Pervushin K, Tan E, Parthasarathy K, Lin X, Jiang FL, Yu D, Vararattanavech A, Soong TW, Liu DX, Torres J. Structure and inhibition of the SARS coronavirus envelope protein ion channel. PLoS Pathog. 2009 Jul;5(7):e1000511. doi: 10.1371/journal.ppat.1000511. Epub 2009 Jul 10.
- Background: PubMed 24145548Barton C, Kouokam JC, Lasnik AB, Foreman O, Cambon A, Brock G, Montefiori DC, Vojdani F, McCormick AA, O'Keefe BR, Palmer KE. Activity of and effect of subcutaneous treatment with the broad-spectrum antiviral lectin griffithsin in two laboratory rodent models. Antimicrob Agents Chemother. 2014;58(1):120-7. doi: 10.1128/AAC.01407-13. Epub 2013 Oct 21.
- Background: PubMed 31125806Pruijssers AJ, Denison MR. Nucleoside analogues for the treatment of coronavirus infections. Curr Opin Virol. 2019 Apr;35:57-62. doi: 10.1016/j.coviro.2019.04.002. Epub 2019 May 21.
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- Background: PubMed 24503068Mielech AM, Kilianski A, Baez-Santos YM, Mesecar AD, Baker SC. MERS-CoV papain-like protease has deISGylating and deubiquitinating activities. Virology. 2014 Feb;450-451:64-70. doi: 10.1016/j.virol.2013.11.040. Epub 2013 Dec 22.
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- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Beatriz H Aristizabal, PhD principal investigator
Unidad de Investigación Genética Molecular
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group A: oropharygeal spray and immunostimulant emulsion in people with COVID, run by Unidad de Investigación Genética Molecular at 1 site in Colombia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Seroconversion of IgM for COVID-19. (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04420260, which also lists 131 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2021.