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

NCT04916574 | Completed

• 1 other identifier: Ico-CT001
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

SARS-COV2 Infection; Covid19

Outcome Measures

Primary Outcomes (1)

• Antibody concentration dynamics

  Concentration of bovine IgG at different timepoints

  4 hours

Study Arms (2)

BioBlock® concentration 0.2 mg/mL

ACTIVE COMPARATOR

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

BioBlock® concentration 0.1 mg/mL

ACTIVE COMPARATOR

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

Interventions

Nasal Spray Containing Anti-SARS-CoV-2 Antibodies Derived from Bovine Colostrum OTHER

Concentration of active substance on nasal mucosal surface in time

BioBlock® concentration 0.1 mg/mL; BioBlock® concentration 0.2 mg/mL

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Icosagen Cell Factory: lead
• Tartu University Hospital: collaborator

Study Sites (1)

Icosagen AS

Tartu, 61713, Estonia

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2021
• First Posted: June 7, 2021
• Study Start: March 20, 2021
• Primary Completion: March 28, 2021
• Study Completion: June 3, 2021
• Last Updated: June 9, 2021

Record last verified: 2021-06

Locations

ES (1)