Clinical trial NCT05552950: 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
Overall status: UNKNOWN
Phase: PHASE4
Conditions: SARS CoV 2 Infection
Keywords: SARS-CoV-2
COVID-19
nasal spray
Antiviral agent
Lead sponsor: Chemi-Pharm AS
Sponsor class: INDUSTRY
First posted: 2022-09-23
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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).


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

Primary outcomes:
measure: effectiveness of the BioBlock®
timeFrame: 3 months
Secondary outcomes:
measure: safety of the BioBlock® virus neutralizing nasal spray
timeFrame: 6 months
Other outcomes:
Locations:
city: Tallinn
country: Estonia
facility: AS Chemi-Pharm
state: Harjumaa
Study officials:
References: