SARS CoV 2 InfectionPhase 4NCT05552950
The Efficacy and Safety of BioBlock® Intranasally Administered Virus-Neutralizing Bovine Colostrum Nasal Spray in Preventing of COVID-19 (Coronavirus Disease-19) Infection in Healthy Volunteer Individuals
A Phase 4 study testing BioBlock® antiviral nasal spray in people with SARS CoV 2 Infection, run by Chemi-Pharm AS at 1 site in Estonia.
Trial summary
This is a proof-of-concept double-blind cluster randomized (1:1) parallel study. The randomization unit is healthy volunteers who have no symptoms of COVID-19 at the start of the study and have not been infected with the SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2) virus in the past 90 days. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- SARS CoV 2 Infection
- What is being tested?
- BioBlock® antiviral nasal spray
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2,000 participants
- Where
- 1 siteEstonia
- Study dates
- 1 May 2022to 30 Dec 2023
- Phase
- Phase 4
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Agree to participate in the study Age: 18-60 years (based on the age group with the best digital competence).
Who cannot join
- Pregnancy
- age less than 18 years and over 60 years,
- a person identified with SARS-CoV-2 infection at the beginning of the study,
- a person with symptoms of SARS-CoV-2 infection,
- a person who has recovered from Covid-19 in the last 3 months,
- a person who regularly takes medicinal products administered by inhalation by nasal and oropharyngeal means.
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- patients with known allergies to BioBlock® components and milk proteins
- BioBlock ingredients are: Purified water • Bovine colostrum SARS-CoV-2 antibodies • Phosphate buffer: DPBS (without Ca and Mg salts) • Viscosity-enhancing agents: PEG400, PVP K30 • Preservative: sodium benzoate • Acidity regulator: citric acid • Mucous membrane moisturizing agent: glycerol • Potassium chloride - buffer solution component • Potassium dihydrogen phosphate - buffer solution component • Sodium chloride - buffer solution component • Disodium phosphate - buffer solution component
- .
- BioBlock® use in the last 24 hours If the subject has taken BioBlock® during the last day and there are no other criteria for exclusion from the study, then the subject is suitable for inclusion in the study from the next day
Trial locations and contacts
1 site in 1 country.
Estonia1 site, 1 recruiting
- Recruiting
AS Chemi-Pharm
Tallinn, Harju
Konstantin Rebrov, MD, 00 372 6778806, Konstantin@chemi-pharm.com
About this study
Official title: Randomized, Controlled, Double-Blind Proof of Concept Trial Assessing the Efficacy and Safety of BioBlock® Intranasally Administered Virus-Neutralizing Bovine Colostrum Nasal Spray in Preventing of COVID-19 Infection in Healthy Volunteer Individuals
This is a proof-of-concept double-blind cluster randomized (1:1) parallel study. The randomization unit is healthy volunteers who have no symptoms of COVID-19 at the start of the study and have not been infected with the SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2) virus in the past 90 days. The selected individuals are randomly grouped in either the experimental group (individuals using the BioBlock® antiviral nasal spray immediately after waking up in the morning and thereafter once every 4 hours and so for 28 days) or the control group (placebo is used by individuals immediately after waking up in the morning and thereafter once every 4 hours and so for 28 days).
- Conditions
- SARS CoV 2 Infection
- Being tested
- BioBlock® antiviral nasal spray
- Keywords
- SARS-CoV-2, COVID-19, nasal spray, Antiviral agent
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BioBlock® antiviral nasal sprayBiological
SARS-CoV-2 BioBlock is a natural preparation derived from bovine colostrum, where animals have an immune response against the SARS-CoV-2 spike protein in addition to conventional vaccines. The antiviral colostrum preparation was made from colostrum of cows immunized with SARS CoV-2 spike protein. Pregnant cows were immunized during the third trimester of gestation using a non-infectious recombinantly produced and purified SARS CoV-2 spike protein. Colostrum, which is milked after calving, concentrates most of the antibodies produced in the cow's body at very high concentrations, including neutralizing antibodies to SARS CoV-2 produced as a result of immunization.
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | Individuals using the BioBlock® antiviral nasal spray immediately after waking up in the morning and thereafter once every 4 hours and so for 28 days. Receives: Biological: BioBlock® antiviral nasal spray |
| control group | Placebo comparator | Placebo is used by individuals immediately after waking up in the morning and thereafter once every 4 hours and so for 28 days. Receives: Biological: BioBlock® antiviral nasal spray |
What is being measured
The primary outcome is the main question the study is designed to answer.
effectiveness of the BioBlock®
BioBlock® nasal spray users are less likely to contract the virus than placebo users. BioBlock effectiveness will be estimated using Cox regression (BPE = 1 - hazard ratio [HR]) or Poisson regression (BPE = 1 - rate ratio [RR]).
Measured: 3 months
Secondary outcomes (1)
safety of the BioBlock® virus neutralizing nasal spray
The use of BioBlock® nasal spray does not cause life-threatening or other significant side effects. Incidence of all possible side effects that person or medical person connects to the use of the product. Side effects are not pre-specified because of the nature of product. Number (%) of adverse events per group are reported. Mean (sd) and median (IQR) duration of symptoms is calculated and compared between groups using linear regression with cluster robust standard errors in case of correlated observations or t-test or Wilcoxon rank-sum test.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2022
- Study start1 May 2022
- Primary completion31 Jul 2023 (estimated)
- Study completion30 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SARS CoV 2 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chemi-Pharm AS
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05552950
- Sponsor's protocol ID
- BioBlock
- Status last verified
- Sep 2022
- First submitted
- 9 Sep 2022
- Last updated
- 8 Feb 2023
- Results posted
- No
- Data monitoring committee
- 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 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Controlled, Double-Blind Proof of Concept Trial Assessing the Efficacy and Safety of BioBlock® Intranasally Administered Virus-Neutralizing Bovine Colostrum Nasal Spray in Preventing of COVID-19 Infection in Healthy Volunteer Individuals
- ClinicalTrials.gov ID
- NCT05552950
- Acronym / sponsor ID
- BioBlock
- Conditions
- SARS CoV 2 Infection
- Keywords
- SARS-CoV-2, COVID-19, nasal spray, Antiviral agent
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Chemi-Pharm ASIndustry (pharma, biotech, devices)
- Study start
- 1 May 2022 (actual)
- Primary completion
- 31 Jul 2023 (estimated)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 23 Sep 2022 (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.
This is a proof-of-concept double-blind cluster randomized (1:1) parallel study. The randomization unit is healthy volunteers who have no symptoms of COVID-19 at the start of the study and have not been infected with the SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2) virus in the past 90 days. The selected individuals are randomly grouped in either the experimental group (individuals using the BioBlock® antiviral nasal spray immediately after waking up in the morning and thereafter once every 4 hours and so for 28 days) or the control group (placebo is used by individuals immediately after waking up in the morning and thereafter once every 4 hours and so for 28 days).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Biological: BioBlock® antiviral nasal sprayIndividuals using the BioBlock® antiviral nasal spray immediately after waking up in the morning and thereafter once every 4 hours and so for 28 days. |
| control group | Placebo comparator | Biological: BioBlock® antiviral nasal sprayPlacebo is used by individuals immediately after waking up in the morning and thereafter once every 4 hours and so for 28 days. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Agree to participate in the study Age: 18-60 years (based on the age group with the best digital competence).
Key exclusion criteria (10 listed)
- Pregnancy
- age less than 18 years and over 60 years,
- a person identified with SARS-CoV-2 infection at the beginning of the study,
- a person with symptoms of SARS-CoV-2 infection,
- a person who has recovered from Covid-19 in the last 3 months,
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 |
|---|---|---|
| BioBlock® antiviral nasal spraySARS-CoV-2 BioBlock is a natural preparation derived from bovine colostrum, where animals have an immune response against the SARS-CoV-2 spike protein in addition to conventional vaccines. The antiviral colostrum preparation was made from colostrum of cows immunized with SARS CoV-2 spike protein. Pregnant cows were immunized during the third trimester of gestation using a non-infectious recombinantly produced and purified SARS CoV-2 spike protein. Colostrum, which is milked after calving, concentrates most of the antibodies produced in the cow's body at very high concentrations, including neutralizing antibodies to SARS CoV-2 produced as a result of immunization. | Biological | control group, experimental group |
Primary outcome
effectiveness of the BioBlock®
Time frame: 3 months
BioBlock® nasal spray users are less likely to contract the virus than placebo users. BioBlock effectiveness will be estimated using Cox regression (BPE = 1 - hazard ratio [HR]) or Poisson regression (BPE = 1 - rate ratio [RR]).
1 secondary outcome
safety of the BioBlock® virus neutralizing nasal spray
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2023.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing BioBlock® antiviral nasal spray in people with SARS CoV 2 Infection, run by Chemi-Pharm AS 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 1 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 8 Feb 2023. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
effectiveness of the BioBlock® (time frame: 3 months). 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 8 Feb 2023.