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PROOF OF CONCEPT TRIAL ASSESSING THE EFFICACY AND SAFETY OF BIOBLOCK®

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 randomized (1: 1) parallel study of a double-blind cluster of proof of concept. The randomization unit is healthy volunteers who have no symptoms of COVID-19 at baseline and have not been infected with SARS-CoV-2 for the past 90 days. Selected subjects are randomly assigned to either an experimental group (subjects using BioBlock® Antiviral Nasal Spray immediately after waking up in the morning and once every 4 hours thereafter for 28 days) or a control group (subjects using placebo immediately after waking up in the morning and once every 4 hours thereafter and so within 28 days).

For both study groups, a rapid COVID-19 antigen test is scheduled twice weekly or when symptoms of COVID-19 infection occur, for 4 consecutive weeks.

It is planned to include 2,000 people aged 18-60 in the study at random from all over Estonia.

Cases of side effects are recorded during the study.

The study is conducted in cooperation with the University of Tartu.

Indicative duration of the study is April 2022-August 2022