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

NCT05552950 | Unknown Phase 4

• 1 other identifier: BioBlock
• Study Type: interventional
• Target: 2,000
• Locations: 1 country
• Sites: 1

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

Keywords

SARS-CoV-2; COVID-19; nasal spray; Antiviral agent

Outcome Measures

Primary Outcomes (1)

• 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 \[RR\]).

  3 months

Secondary Outcomes (1)

• safety of the BioBlock® virus neutralizing nasal spray

  6 months

Study Arms (2)

experimental group

EXPERIMENTAL

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

control group

PLACEBO COMPARATOR

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

Interventions

BioBlock® antiviral nasal spray 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; experimental group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chemi-Pharm AS: lead

Study Sites (1)

AS Chemi-Pharm

Tallinn, Harju, Estonia

RECRUITING

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2022
• First Posted: September 23, 2022
• Study Start: May 1, 2022
• Primary Completion: July 31, 2023
• Study Completion: December 30, 2023
• Last Updated: February 8, 2023

Record last verified: 2022-09

Locations

ES (1)