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The Efficacy and Safety of BioBlock® Intranasally Administered Virus-Neutralizing Bovine Colostrum Nasal Spray in Preventing of COVID-19 (Coronavirus Disease-19) Infection in Healthy Volunteer Individuals

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ClinicalTrials.gov Identifier: NCT05552950
Recruitment Status : Recruiting
First Posted : September 23, 2022
Last Update Posted : February 8, 2023
Sponsor:
Information provided by (Responsible Party):
Chemi-Pharm AS

Study Description
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Brief Summary:
This is a proof-of-concept double-blind cluster randomized (1:1) parallel study. The randomization unit is healthy volunteers who have no symptoms of COVID-19 at the start of the study and have not been infected with the SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2) virus in the past 90 days. The selected individuals are randomly grouped in either the experimental group (individuals using the BioBlock® antiviral nasal spray immediately after waking up in the morning and thereafter once every 4 hours and so for 28 days) or the control group (placebo is used by individuals immediately after waking up in the morning and thereafter once every 4 hours and so for 28 days).

Condition or disease Intervention/treatment Phase
SARS CoV 2 Infection Biological: BioBlock® antiviral nasal spray Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Masking Description: The study and control sprays can only be distinguished by serial numbers, the content of which is not known by the study staff or the subjects.
Primary Purpose: Prevention
Official Title: Randomized, Controlled, Double-Blind Proof of Concept Trial Assessing the Efficacy and Safety of BioBlock® Intranasally Administered Virus-Neutralizing Bovine Colostrum Nasal Spray in Preventing of COVID-19 Infection in Healthy Volunteer Individuals
Actual Study Start Date : May 1, 2022
Estimated Primary Completion Date : July 31, 2023
Estimated Study Completion Date : December 30, 2023

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Arms and Interventions
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Arm Intervention/treatment
Experimental: experimental group
Individuals using the BioBlock® antiviral nasal spray immediately after waking up in the morning and thereafter once every 4 hours and so for 28 days.
 Biological: BioBlock® antiviral nasal spray
SARS-CoV-2 BioBlock is a natural preparation derived from bovine colostrum, where animals have an immune response against the SARS-CoV-2 spike protein in addition to conventional vaccines. The antiviral colostrum preparation was made from colostrum of cows immunized with SARS CoV-2 spike protein. Pregnant cows were immunized during the third trimester of gestation using a non-infectious recombinantly produced and purified SARS CoV-2 spike protein. Colostrum, which is milked after calving, concentrates most of the antibodies produced in the cow's body at very high concentrations, including neutralizing antibodies to SARS CoV-2 produced as a result of immunization.
Placebo Comparator: control group
Placebo is used by individuals immediately after waking up in the morning and thereafter once every 4 hours and so for 28 days.
 Biological: BioBlock® antiviral nasal spray
SARS-CoV-2 BioBlock is a natural preparation derived from bovine colostrum, where animals have an immune response against the SARS-CoV-2 spike protein in addition to conventional vaccines. The antiviral colostrum preparation was made from colostrum of cows immunized with SARS CoV-2 spike protein. Pregnant cows were immunized during the third trimester of gestation using a non-infectious recombinantly produced and purified SARS CoV-2 spike protein. Colostrum, which is milked after calving, concentrates most of the antibodies produced in the cow's body at very high concentrations, including neutralizing antibodies to SARS CoV-2 produced as a result of immunization.


Outcome Measures
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Primary Outcome Measures :
  1. effectiveness of the BioBlock® [ Time Frame: 3 months ]
    BioBlock® nasal spray users are less likely to contract the virus than placebo users. BioBlock effectiveness will be estimated using Cox regression (BPE = 1 - hazard ratio [HR]) or Poisson regression (BPE = 1 - rate ratio [RR]).


Secondary Outcome Measures :
  1. safety of the BioBlock® virus neutralizing nasal spray [ Time Frame: 6 months ]
    The use of BioBlock® nasal spray does not cause life-threatening or other significant side effects. Incidence of all possible side effects that person or medical person connects to the use of the product. Side effects are not pre-specified because of the nature of product. Number (%) of adverse events per group are reported. Mean (sd) and median (IQR) duration of symptoms is calculated and compared between groups using linear regression with cluster robust standard errors in case of correlated observations or t-test or Wilcoxon rank-sum test.


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:

Agree to participate in the study Age: 18-60 years (based on the age group with the best digital competence).

Exclusion Criteria:

  • Pregnancy
  • age less than 18 years and over 60 years,
  • a person identified with SARS-CoV-2 infection at the beginning of the study,
  • a person with symptoms of SARS-CoV-2 infection,
  • a person who has recovered from Covid-19 in the last 3 months,
  • a person who regularly takes medicinal products administered by inhalation by nasal and oropharyngeal means.

  • patients with known allergies to BioBlock® components and milk proteins

    • BioBlock ingredients are: Purified water • Bovine colostrum SARS-CoV-2 antibodies • Phosphate buffer: DPBS (without Ca and Mg salts) • Viscosity-enhancing agents: PEG400, PVP K30 • Preservative: sodium benzoate • Acidity regulator: citric acid • Mucous membrane moisturizing agent: glycerol • Potassium chloride - buffer solution component • Potassium dihydrogen phosphate - buffer solution component • Sodium chloride - buffer solution component • Disodium phosphate - buffer solution component
    • .
  • BioBlock® use in the last 24 hours If the subject has taken BioBlock® during the last day and there are no other criteria for exclusion from the study, then the subject is suitable for inclusion in the study from the next day
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): NCT05552950


Locations
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Estonia
AS Chemi-Pharm Recruiting
Tallinn, Harjumaa, Estonia
Contact: Konstantin Rebrov, MD    00 372 6778806    Konstantin@chemi-pharm.com   
Sponsors and Collaborators
Chemi-Pharm AS
More Information
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Responsible Party: Chemi-Pharm AS
ClinicalTrials.gov Identifier: NCT05552950    
Other Study ID Numbers: BioBlock
First Posted: September 23, 2022    Key Record Dates
Last Update Posted: February 8, 2023
Last Verified: September 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Chemi-Pharm AS:
SARS-CoV-2
COVID-19
nasal spray
Antiviral agent
Additional relevant MeSH terms:
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Infections
Communicable Diseases
COVID-19
Disease Attributes
Pathologic Processes
Pneumonia, Viral
Pneumonia
Respiratory Tract Infections
Virus Diseases
 Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Antiviral Agents
Anti-Infective Agents