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Completed

NCT Number: NCT04916574

Clinical Trial of BioBlock COVID-19 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.

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Key information

Conditions

SARS-CoV2 Infection COVID-19 Coronaviridae Infections Coronavirus Infections Covid19 Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Icosagen AS

Tartu, 61713, Estonia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other

Concentration of active substance on nasal mucosal surface in time

Primary outcomes

  1. Antibody concentration dynamics

    Time frame: 4 hours

    Concentration of bovine IgG at different timepoints

Sponsors and collaborators

Lead sponsor

Icosagen Cell Factory

Industry

Collaborators

  • Tartu University Hospital

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jun 7, 2021
Registry last updated
Jun 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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