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
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
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).
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® 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