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
Brief Summary

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

Detailed Description

Not Provided

Unknown status
SARS CoV 2 Infection

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.

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

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: 60 Years
Countries
Estonia
Locations

AS Chemi-Pharm
Tallinn, Harjumaa, Estonia

Investigator: Konstantin Rebrov, MD
Contact: 00 372 6778806
Konstantin@chemi-pharm.com

Not Provided

Chemi-Pharm AS
NCT Number
Keywords
SARS-CoV-2
Covid-19
nasal spray
Antiviral agent
MeSH Terms
Infections
Communicable Diseases
COVID-19
Antiviral Agents