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

NCT ID: NCT05552950

Last Updated: 2023-02-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 2000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-01
• Study Completion Date: 2023-12-30

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).

Conditions

SARS CoV 2 Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

BioBlock® antiviral nasal spray

Intervention Type: BIOLOGICAL

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.

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.

Group Type: PLACEBO_COMPARATOR

BioBlock® antiviral nasal spray

Intervention Type: BIOLOGICAL

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.

Interventions

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.

Intervention Type: BIOLOGICAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Chemi-Pharm AS

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

AS Chemi-Pharm

Tallinn, Harju, Estonia

Site Status: RECRUITING

Countries

Estonia

Facility Contacts

Konstantin Rebrov, MD

Role: primary

Konstantin@chemi-pharm.com

00 372 6778806

Other Identifiers

BioBlock

Identifier Type: -

Identifier Source: org_study_id