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

Last updated: February 6, 2023
Sponsor: Chemi-Pharm AS
Overall Status: Active - Recruiting

Phase

4

Condition

Covid-19

Treatment

N/A

Clinical Study ID

NCT05552950
BioBlock
  • Ages 18-60
  • All Genders
  • Accepts Healthy Volunteers

Study 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).

Eligibility Criteria

Inclusion

Inclusion Criteria: Agree to participate in the study Age: 18-60 years (based on the age group with the bestdigital competence).

Exclusion

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 nasaland 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 - buffersolution component • Potassium dihydrogen phosphate - buffer solution component •Sodium chloride - buffer solution component • Disodium phosphate - buffersolution component
  • .
  • BioBlock® use in the last 24 hours If the subject has taken BioBlock® during the lastday and there are no other criteria for exclusion from the study, then the subject issuitable for inclusion in the study from the next day

Study Design

Total Participants: 2000
Study Start date:
May 01, 2022
Estimated Completion Date:
December 30, 2023

Connect with a study center

  • AS Chemi-Pharm

    Tallinn, Harjumaa
    Estonia

    Active - Recruiting

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