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
- Conditions
- SARS CoV 2 Infection
- Interventions
- Biological: BioBlock® antiviral nasal spray
- Registration Number
- NCT05552950
- Lead Sponsor
- Chemi-Pharm AS
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 2000
Agree to participate in the study Age: 18-60 years (based on the age group with the best digital competence).
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Pregnancy
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age less than 18 years and over 60 years,
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a person identified with SARS-CoV-2 infection at the beginning of the study,
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a person with symptoms of SARS-CoV-2 infection,
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a person who has recovered from Covid-19 in the last 3 months,
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a person who regularly takes medicinal products administered by inhalation by nasal and oropharyngeal means.
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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
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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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description control group BioBlock® antiviral nasal spray Placebo is used by individuals immediately after waking up in the morning and thereafter once every 4 hours and so for 28 days. experimental group BioBlock® antiviral nasal spray 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.
- Primary Outcome Measures
Name Time Method effectiveness of the BioBlock® 3 months 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 \[RR\]).
- Secondary Outcome Measures
Name Time Method safety of the BioBlock® virus neutralizing nasal spray 6 months The use of BioBlock® nasal spray does not cause life-threatening or other significant side effects. Incidence of all possible side effects that person or medical person connects to the use of the product. Side effects are not pre-specified because of the nature of product. Number (%) of adverse events per group are reported. Mean (sd) and median (IQR) duration of symptoms is calculated and compared between groups using linear regression with cluster robust standard errors in case of correlated observations or t-test or Wilcoxon rank-sum test.
Trial Locations
- Locations (1)
AS Chemi-Pharm
🇪🇪Tallinn, Harjumaa, Estonia