Clinical Trial of BioBlock COVID-19 Nasal Spray Containing Anti-SARS-CoV-2 Antibodies Derived From Bovine Colostrum

Clinical Trial of Nasal Spray Containing Anti-SARS-CoV-2 Antibodies Derived From Bovine Colostrum

For an antiviral agent to act as an effective biological barrier on nasal mucosal surface, the formulation preferably has to be maintained on the site of action for several hours, and the nasal spray dispenser can be utilized for administering the solution to the upper respiratory tract. A "first-in-man" clinical study of the nasal spray containing anti-SARS-CoV-2 antibodies derived from bovine colostrum was conducted. The study on healthy volunteers was undertaken to evaluate how long the bovine antibodies would be maintained on the nasopharyngeal surface after administration of nasal spray. In addition, the study enabled to determine which of the two concentrations of antibodies should be used in the final nasal-spray formulation. The volunteers were followed up for 4h after administration of antibody spray and sampling was done at different time-points during this period. The concentration of antibodies from patient samples was measured using ELISA analysis. In addition, as this was a "first-in-man" study any adverse events following the administration of spray were also monitored.

Study Overview

• Status: Completed
• Conditions: Covid19; SARS-COV2 Infection
• Intervention / Treatment: Other: Nasal Spray Containing Anti-SARS-CoV-2 Antibodies Derived from Bovine Colostrum

Detailed Description

To test the nasal biological availability of the BioBlock® immunoglobulin preparation, 16 healthy volunteers were recruited in the phase 0 clinical trial. The study was conducted in the premises of the Ear Clinic of Tartu University Hospital. The study protocol was approved by Research Ethics Committee of the University of Tartu on March 17, 2021 (No 336/T-1). Written informed consent in accordance with the Declaration of Helsinki was obtained from each healthy volunteer. The study group was divided into two subgroups where the individuals were intranasally administered into both nostrils of BioBlock® formulation which contained either 0.1 mg/mL or 0.2 mg/mL of the colostrum immunoglobulin preparation (n=8 in both study groups). A filter paper with a volume capacity of 15 µL was placed on the medial nasal surface using surgical forceps and it was kept on nasal mucosa for 10 minutes. Following this the BioBlock was administered to the nasal cavity. The nasal mucosal sampling was done at 4 timepoints. The samples were analyzed using a Cow IgG ELISA kit.

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Estonia
  • Tartu, Estonia, 61713
    • Icosagen AS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Healthy individuals
• Age 18-80
• Have not been diagnosed with SARS-COV-2 infection (lack of positive PCR test)
• Have not been vaccinated against SARS-COV-2 infection

Exclusion Criteria:

• Pregnancy
• Serious allergic or anaphylactic reactions to medications
• Allergies to milk products
• Ear-nose-throat pathologies (anatomic and diseases)
• Immunodeficiency conditions (cancers, hematologic diseases, HIV, congenital immunodeficiency)
• Viral hepatitis A,B and C
• Upper airway infections
• Autoimmune diseases (diabetes, COPD, asthma, rhinitis, RA, psoriasis)
• Concomitant drugs - glucocorticosteroids, biologic drugs, inhalable medications

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: BioBlock® concentration 0.2 mg/mL; BioBlock®: Nasal Spray Containing Anti-SARS-CoV-2 Antibodies Derived from Bovine Colostrum	Other: Nasal Spray Containing Anti-SARS-CoV-2 Antibodies Derived from Bovine Colostrum; Concentration of active substance on nasal mucosal surface in time
Active Comparator: BioBlock® concentration 0.1 mg/mL; BioBlock®: Nasal Spray Containing Anti-SARS-CoV-2 Antibodies Derived from Bovine Colostrum	Other: Nasal Spray Containing Anti-SARS-CoV-2 Antibodies Derived from Bovine Colostrum; Concentration of active substance on nasal mucosal surface in time

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Antibody concentration dynamics	Concentration of bovine IgG at different timepoints	4 hours

Collaborators and Investigators

• Sponsor: Icosagen Cell Factory
• Collaborators: Tartu University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 20, 2021
• Primary Completion (Actual): March 28, 2021
• Study Completion (Actual): June 3, 2021

Study Registration Dates

• First Submitted: June 3, 2021
• First Submitted That Met QC Criteria: June 4, 2021
• First Posted (Actual): June 7, 2021

Study Record Updates

• Last Update Posted (Actual): June 9, 2021
• Last Update Submitted That Met QC Criteria: June 7, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Physiological Effects of Drugs; Immunologic Factors; Antibodies
• Other Study ID Numbers: Ico-CT001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No