SARS-COV2 InfectionNCT04916574
Clinical Trial of BioBlock COVID-19 Nasal Spray Containing Anti-SARS-CoV-2 Antibodies Derived From Bovine Colostrum
A study testing Nasal Spray Containing Anti-SARS-CoV-2 Antibodies Derived from Bovine Colostrum in people with SARS-COV2 Infection and Covid19, run by Icosagen Cell Factory at 1 site in Estonia.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- SARS-COV2 Infection, Covid19
- What is being tested?
- Nasal Spray Containing Anti-SARS-CoV-2 Antibodies Derived from Bovine Colostrum
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteEstonia
- Study dates
- 20 Mar 2021to 3 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Upper airway infections
- Autoimmune diseases (diabetes, COPD, asthma, rhinitis, RA, psoriasis)
- Concomitant drugs - glucocorticosteroids, biologic drugs, inhalable medications
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Trial of 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.
Read the 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 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.
- Conditions
- SARS-COV2 Infection, Covid19
- Being tested
- Nasal Spray Containing Anti-SARS-CoV-2 Antibodies Derived from Bovine Colostrum
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nasal Spray Containing Anti-SARS-CoV-2 Antibodies Derived from Bovine ColostrumOther
Concentration of active substance on nasal mucosal surface in time
| Study group | Role | What they receive |
|---|---|---|
| BioBlock® concentration 0.2 mg/mL | Active comparator | BioBlock®: Nasal Spray Containing Anti-SARS-CoV-2 Antibodies Derived from Bovine Colostrum Receives: 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 Receives: Other: Nasal Spray Containing Anti-SARS-CoV-2 Antibodies Derived from Bovine Colostrum |
What is being measured
The primary outcome is the main question the study is designed to answer.
Antibody concentration dynamics
Concentration of bovine IgG at different timepoints
Measured: 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2021
- Study start20 Mar 2021
- Primary completion28 Mar 2021
- Study completion3 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SARS-COV2 InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icosagen Cell Factory
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Tartu University Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04916574
- Sponsor's protocol ID
- Ico-CT001
- Status last verified
- Jun 2021
- First submitted
- 3 Jun 2021
- Last updated
- 9 Jun 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial of Nasal Spray Containing Anti-SARS-CoV-2 Antibodies Derived From Bovine Colostrum
- ClinicalTrials.gov ID
- NCT04916574
- Acronym / sponsor ID
- Ico-CT001
- Conditions
- SARS-COV2 Infection, Covid19
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Icosagen Cell FactoryIndustry (pharma, biotech, devices)
- Collaborators
- Tartu University Hospital
- Study start
- 20 Mar 2021 (actual)
- Primary completion
- 28 Mar 2021 (actual)
- Study completion
- 3 Jun 2021 (actual)
- First posted
- 7 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BioBlock® concentration 0.2 mg/mL | Active comparator | Other: Nasal Spray Containing Anti-SARS-CoV-2 Antibodies Derived from Bovine ColostrumBioBlock®: Nasal Spray Containing Anti-SARS-CoV-2 Antibodies Derived from Bovine Colostrum |
| BioBlock® concentration 0.1 mg/mL | Active comparator | Other: Nasal Spray Containing Anti-SARS-CoV-2 Antibodies Derived from Bovine ColostrumBioBlock®: Nasal Spray Containing Anti-SARS-CoV-2 Antibodies Derived from Bovine Colostrum |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nasal Spray Containing Anti-SARS-CoV-2 Antibodies Derived from Bovine ColostrumConcentration of active substance on nasal mucosal surface in time | Other | BioBlock® concentration 0.1 mg/mL, BioBlock® concentration 0.2 mg/mL |
Primary outcome
Antibody concentration dynamics
Time frame: 4 hours
Concentration of bovine IgG at different timepoints
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nasal Spray Containing Anti-SARS-CoV-2 Antibodies Derived from Bovine Colostrum in people with SARS-COV2 Infection and Covid19, run by Icosagen Cell Factory at 1 site in Estonia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Estonia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Antibody concentration dynamics (time frame: 4 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2021.