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

Covid19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04916574
• Other study ID #: Ico-CT001
• Status: Completed
• Phase: N/A
• Start date: March 20, 2021
• Est. completion date: June 3, 2021

Study information

• Verified date: June 2021
• Source: Icosagen Cell Factory
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: June 3, 2021
• Est. primary completion date: March 28, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Covid19
• SARS-COV2 Infection

Intervention

Other:
• Nasal Spray Containing Anti-SARS-CoV-2 Antibodies Derived from Bovine Colostrum
Concentration of active substance on nasal mucosal surface in time

Locations

Country	Name	City	State
Estonia	Icosagen AS	Tartu

Sponsors (2)

Lead Sponsor	Collaborator
Icosagen Cell Factory	Tartu University Hospital

Country where clinical trial is conducted

Estonia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Antibody concentration dynamics	Concentration of bovine IgG at different timepoints	4 hours