Back to resultsThe 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
Primary Purpose
SARS CoV 2 Infection
Status
Recruiting
Phase
Phase 4
Locations
Estonia
Study Type
Interventional
Intervention
BioBlock® antiviral nasal spray
Sponsored by
About this trial
This is an interventional prevention trial for SARS CoV 2 Infection focused on measuring SARS-CoV-2, COVID-19, nasal spray, Antiviral agent
Eligibility 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
Sites / Locations
- AS Chemi-PharmRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
experimental group
control group
Arm Description
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.
Placebo is used by individuals immediately after waking up in the morning and thereafter once every 4 hours and so for 28 days.
Outcomes
Primary Outcome Measures
effectiveness of the BioBlock®
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
safety of the BioBlock® virus neutralizing nasal spray
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05552950
Brief Title
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
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2022 (Actual)
Primary Completion Date
July 31, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chemi-Pharm AS
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
SARS CoV 2 Infection
Keywords
SARS-CoV-2, COVID-19, nasal spray, Antiviral agent
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare 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.
Allocation
Randomized
Enrollment
2000 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
experimental group
Arm Type
Experimental
Arm Description
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.
Arm Title
control group
Arm Type
Placebo Comparator
Arm Description
Placebo is used by individuals immediately after waking up in the morning and thereafter once every 4 hours and so for 28 days.
Intervention Type
Biological
Intervention Name(s)
BioBlock® antiviral nasal spray
Intervention Description
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.
Primary Outcome Measure Information:
Title
effectiveness of the BioBlock®
Description
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]).
Time Frame
3 months
Secondary Outcome Measure Information:
Title
safety of the BioBlock® virus neutralizing nasal spray
Description
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.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
Facility Name
AS Chemi-Pharm
City
Tallinn
State/Province
Harjumaa
Country
Estonia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Konstantin Rebrov, MD
Phone
00 372 6778806
Email
Konstantin@chemi-pharm.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
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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