BioBlock nasal spray against COVID-19
| ISRCTN | ISRCTN48554326 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN48554326 |
| Secondary identifying numbers | Protocol v1 |
- Submission date
- 02/05/2021
- Registration date
- 14/06/2021
- Last edited
- 02/02/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Plain English Summary
Background and study aims
COVID-19 is a condition caused by the coronavirus (called SARS-CoV-2) that was first identified in late 2019. This virus can infect the respiratory (breathing) system. Some people do not have symptoms but can carry the virus and pass it on to others. People who have developed the condition may develop a fever and/or a continuous cough among other symptoms. This can develop into pneumonia. Pneumonia is a chest infection where the small air pockets of the lungs, called alveoli, fill with liquid and make it more difficult to breathe.
The nose is both a source of pathogens and a critical port of entry for infectious agents such as viruses and bacteria. Prevention of SARS-CoV-2 infection at the point of nasal entry is a novel strategy that has the potential to help contain the ongoing pandemic. Households are high-risk settings for SARS-CoV-2 transmission. Those with confirmed or suspected infections are required to isolate at home, putting other members of their household at an increased risk.
There is a need for research exploring whether directly applying SARS-CoV-2 antibodies into the upper respiratory airway is effective as a prevention or treatment strategy in an exposed household setting. The study team will test the antiviral preparation prepared from colostrum from cows immunized with SARS CoV-2 spike protein.
Who can participate?
Adults with confirmed COVID-19 and their SARS-CoV-2 RNA negative adult household members recruited from two participating family physician practices.
What does the study involve?
The patients and their households will be allocated to receive either BioBlock treatment or to receive an identical spray with no active medicine (placebo), with an equal chance of being in either group (like tossing a coin). Patients will administer BioBlock or placebo for 14 days. COVID-19 patients will have their symptoms recorded until up to a maximum of 21 days follow-up. Respiratory samples will be collected at 14 days. Household members will have their symptoms recorded until up to a maximum of 14 days and respiratory samples collected at 14 days.
What are the possible benefits and risks of participating?
There is currently no evidence relating to the benefits and risks of using this nasal spray. Administering Bioblock nasal spray to people with COVID-19 might help them fight the infection and to people without COVID-19 to prevent them from infection. It is possible that using nasal spray could cause some unwanted effects, including irritation, or allergic reactions. To mitigate these effects individuals with selected conditions will be excluded from the study.
Where is the study run from?
University of Tartu (Estonia)
When is the study starting and how long is it expected to run for?
From February 2021 to December 2021
Who is funding the study?
AS CHEMI-PHARM (Estonia)
Who is the main contact?
Prof Anneli Uusküla
anneli.uuskula@ut.ee
Contact information
Scientific
Ravila 19
Tartu
50411
Estonia
 ORCID ID |
0000-0002-4036-3856 |
|---|---|
| Phone | +3727374195 |
| anneli.uuskula@ut.ee |
Study information
| Study design | Cluster randomized triple-blinded controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised parallel trial |
| Study setting(s) | GP practice |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Cluster randomized, controlled, triple-blind trial assessing the efficacy of intranasally administered virus-neutralizing bovine colostrum supplement in preventing SARS-CoV-2 infection in household contacts of SARS-CoV-2 positive individuals |
| Study acronym | BioBlock |
| Study hypothesis | 1. In close contacts of a SARS-CoV-2 carrier, using BioBlock nasal spray would be associated with a lower SARS-CoV-2 infection rate at day 14 2. In patients with confirmed SARS-CoV-2 infection, using BioBlock nasal spray would be associated with improved clinical outcomes at day 21 |
| Ethics approval(s) | Approved 26/04/2021, Research Ethics Committee of the University of Tartu (University of Tartu, Raekoja plats 9, 51004 Tartu, Estonia; +372 737 6215; eetikakomitee@ut.ee), ref: 339/T-1 |
| Condition | Prevention of COVID-19 (SARS-CoV-2 infection) among in household contacts of SARS-CoV-2 positive individuals |
| Intervention | This is a cluster randomized placebo-controlled trial of household contacts of laboratory-confirmed cases of COVID-19 compared to an uninfected control group of household contacts. Participants, investigators, and outcome assessors will be blind to allocation. The placebo and BioBlock sprays will be blinded at the site of manufacture. At a minimum, enrolled household cases and contacts will complete data and specimen collection at enrollment (Day 1) and for 14 days of follow-up, with at least two follow-up visits interviews for household contacts and three follow-up visits for index cases. Household (index case and household contacts) respiratory samples will be collected for SARS-CoV-2 RNA testing at 1 and 14 days. Questionnaires will be completed by Index cases at 1, 7, 14, and 21 days and by SARS-CoV-2 PCR negative household contacts at 1, 7, 14 days. |
| Intervention type | Device |
| Pharmaceutical study type(s) | |
| Phase | Phase II |
| Drug / device / biological / vaccine name(s) | A nasal spray containing colostrum preparation of SARS-CoV-2 antiviral antibodies |
| Primary outcome measure | Rate of COVID-19 infection in household members measured using PCR swab taken at 1 and 14 days |
| Secondary outcome measures | Severity of COVID-19 infection measured using the time taken for all symptoms to resolve (days) from participant questionnaires at 1, 7, 14, 21 days for index cases and 1, 7, 14 days for SARS-CoV-2 PCR negative household contacts |
| Overall study start date | 10/02/2021 |
| Overall study end date | 30/12/2021 |
Eligibility
| Participant type(s) | Mixed |
|---|---|
| Age group | Mixed |
| Sex | Both |
| Target number of participants | 218 household contacts and 124 SARS-CoV-2 positive index patients |
| Participant inclusion criteria | Index case: 1.Confirmed case of COVID-19 infection with at least one SARS-CoV-2 PCR negative person household contact 2. Aged ≥16 years Household contacts: 1. SARS-CoV-2 PCR negative household contact of the index case 2. Aged ≥16 years |
| Participant exclusion criteria | Current exclusion criteria as of 27/08/2021: 1. Aged <16 years 2. Pregnancy 3. Use of active cancer treatment 4. Use of biological treatment 5. Previously confirmed COVID-19 6. Any organ transplantation 7. Single person household 8. Requires hospitalisation prior to study start 9. Required to take regular medications administered by inhalation, or via the naso- and oropharyngeal route 10. Asthma 11. Known allergies to BioBlock components Previous exclusion criteria: 1. Aged <16 years 2. Pregnancy 3. Use of active cancer treatment 4. Use of biological treatment 5. Previously vaccinated against COVID-19 6. Previously confirmed COVID-19 7. Any organ transplantation 8. Single person household 9. Requires hospitalisation prior to study start 10. Required to take regular medications administered by inhalation, or via the naso- and oropharyngeal route 11. Asthma 12. Known allergies to BioBlock components |
| Recruitment start date | 12/05/2021 |
| Recruitment end date | 30/12/2021 |
Locations
Countries of recruitment
- Estonia
Study participating centres
Tallinn
10611
Estonia
Tallinn
12618
Estonia
Sponsor information
University/education
Ülikooli 18
Tartu
50090
Estonia
| Phone | +3727375100 |
|---|---|
| info@ut.ee | |
| Website | http://www.ut.ee |
"ROR" |
https://ror.org/03z77qz90 |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 30/04/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publications in a high-impact peer-reviewed journal. |
| IPD sharing plan | The data sharing plans for the current study are unknown and will be made available at a later date. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | 31/01/2022 | 02/02/2022 | Yes | No |
Editorial Notes
02/02/2022: Publication reference added.
27/08/2021: The following changes were made to the trial record:
1. The recruitment end date was changed from 07/08/2021 to 30/12/2021.
2. The overall trial end date was changed from 30/08/2021 to 30/12/2021.
3. The intention to publish date was changed from 30/12/2021 to 30/04/2022.
4. The target number of participants was changed from '248 household contacts and 124 SARS-CoV-2 positive index patients' to '218 household contacts and 124 SARS-CoV-2 positive index patients'.
5. The exclusion criteria were updated.
10/05/2021: Trial’s existence confirmed by Research Ethics Committee of the University of Tartu.
