Status:
COMPLETED
Clinical Trial of BioBlock COVID-19 Nasal Spray Containing Anti-SARS-CoV-2 Antibodies Derived From Bovine Colostrum
Lead Sponsor:
Icosagen Cell Factory
Collaborating Sponsors:
Tartu University Hospital
Conditions:
SARS-COV2 Infection
Covid19
Eligibility:
All Genders
18-80 years
Phase:
NA
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 ...
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 th...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 20 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 3 2021
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT04916574
Start Date
March 20 2021
End Date
June 3 2021
Last Update
June 9 2021
Active Locations (1)
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1
Icosagen AS
Tartu, Estonia, 61713