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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

Tracking Information
First Submitted Date  ICMJE September 9, 2022
First Posted Date  ICMJE September 23, 2022
Last Update Posted Date February 8, 2023
Actual Study Start Date  ICMJE May 1, 2022
Estimated Primary Completion Date July 31, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 22, 2022)
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]).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 22, 2022)
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.
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 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
Official Title  ICMJE 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
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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE 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
Condition  ICMJE SARS CoV 2 Infection
Intervention  ICMJE 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.
Study Arms  ICMJE
  • 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.
    Intervention: Biological: BioBlock® antiviral nasal spray
  • 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.
    Intervention: Biological: BioBlock® antiviral nasal spray
Publications * Not Provided

*   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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 22, 2022)
2000
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 30, 2023
Estimated Primary Completion Date July 31, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Listed Location Countries  ICMJE Estonia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05552950
Other Study ID Numbers  ICMJE BioBlock
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Current Responsible Party Chemi-Pharm AS
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Chemi-Pharm AS
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Chemi-Pharm AS
Verification Date September 2022

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