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

NCT04916574 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2021-06-09

No results posted yet for this study

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

Interventions

OTHER

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

Concentration of active substance on nasal mucosal surface in time

Sponsors & Collaborators

  • Tartu University Hospital

    collaborator OTHER

  • Icosagen Cell Factory

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-03-20
Primary Completion
2021-03-28
Completion
2021-06-03

Countries

  • Estonia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04916574 on ClinicalTrials.gov