COVID 19NCT04462627
Reduction of COVID 19 Transmission to Health Care Professionals
A study testing Blood group determination, Antibody titration and Probiotic in people with COVID 19, run by Hanane EL KENZ at 1 site in Belgium.
Trial summary
When the COVID-19 virus infects a person, it enters the lung epithelial cells of its host and uses its genetic material to replicate. The pulmonary epithelial cells of a part of the population, known as "secretors", are capable of expressing the antigens of the "ABO" system on their surface. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- COVID 19
- What is being tested?
- Blood group determination, Antibody titration and Probiotic
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 566 participants
- Where
- 1 siteBelgium
- Study dates
- 14 Apr 2020to 11 Apr 2022
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- COVID19 positive patients admitted within the CHU Brugmann Hospital
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
When the COVID-19 virus infects a person, it enters the lung epithelial cells of its host and uses its genetic material to replicate.
The pulmonary epithelial cells of a part of the population, known as "secretors", are capable of expressing the antigens of the "ABO" system on their surface. This secretory status can be established by determining the antigens of the Lewis blood group system. When the virus replicates in an "secreting" individual, the antigens of the "ABO" system of the infected individual will be present on the surface of the viruses formed in his/her lungs.
Read more
It was shown in 2003 that the response of a given individual to the transmission of a virus depends on his/her blood group and on the antigens of the "ABO" system carried by the virus. A patient of group "O" would thus defend himself much better against a virus carrying antigens of blood group "A", the natural antibodies "anti-A" of the patient reducing the ability of the virus to bind to its specific receptor on pulmonary epithelial cells, to penetrate them to replicate itself. The first data collected in Wuhan (China) seems to confirm this hypothesis. A COVID-19 virus transmission model can therefore be established on the basis of blood groups.
In order to reduce the spread of the virus among nursing staff, it is possible to establish a preferential algorithm for patient management based on the "ABO" and "Lewis" blood groups of patients and "ABO" of nursing staff in health care units, if operational and human conditions allow.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood group determinationDiagnostic test
Determination of the blood group (ABO/LE)
Antibody titrationDiagnostic test
Natural anti-A and anti-B antibody levels will be determined by a gel agglutination technique on the Biorad IH-500 automaton.
ProbioticDietary supplement
Administration of a probiotic to healthy volunteers to determine if it increases the level of circulating natural anti-A and anti-B antibodies (Probactiol Plus (Metagenics)).
| Study group | Role | What they receive |
|---|---|---|
| Covid 19 positive patients | Experimental | Not described Receives: Diagnostic Test: Blood group determination; Diagnostic Test: Antibody titration |
| Covid 19 negative patients | Experimental | Not described Receives: Diagnostic Test: Blood group determination; Diagnostic Test: Antibody titration |
| Untested healthy volunteers | Experimental | Not described Receives: Diagnostic Test: Blood group determination; Diagnostic Test: Antibody titration; Dietary Supplement: Probiotic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anti-A antibody concentration
Anti-A antibody titration, as determined by gel agglutination on the Biorad IH-500 automated system.
Measured: baseline
Anti-A antibody concentration
Anti-A antibody titration, as determined by gel agglutination on the Biorad IH-500 automated system.
Measured: Day 4
Anti-A antibody concentration
Anti-A antibody titration, as determined by gel agglutination on the Biorad IH-500 automated system.
Measured: Week 1
Anti-A antibody concentration
Anti-A antibody titration, as determined by gel agglutination on the Biorad IH-500 automated system.
Measured: Week 2
Anti-A antibody concentration
Anti-A antibody titration, as determined by gel agglutination on the Biorad IH-500 automated system.
Measured: Week 3
Anti-B antibody concentration
Anti-B antibody titration, as determined by gel agglutination on the Biorad IH-500 automated system.
Measured: baseline
Anti-B antibody concentration
Anti-B antibody titration, as determined by gel agglutination on the Biorad IH-500 automated system.
Measured: Day 4
Anti-B antibody concentration
Anti-B antibody titration, as determined by gel agglutination on the Biorad IH-500 automated system.
Measured: Week 1
Anti-B antibody concentration
Anti-B antibody titration, as determined by gel agglutination on the Biorad IH-500 automated system.
Measured: Week 2
Anti-B antibody concentration
Anti-B antibody titration, as determined by gel agglutination on the Biorad IH-500 automated system.
Measured: Week 3
Blood group
Blood group (ABO/LE)
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2020
- Study start14 Apr 2020
- Primary completion11 Apr 2022
- Study completion11 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID 19Studies 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
- 566 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hanane EL KENZ
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hanane EL KENZ, Brugmann University Hospital
- Investigators
- Hanane El Kenz, MD, Principal investigator, CHU Brugmann
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04462627
- Sponsor's protocol ID
- CHUB-BDS-COVID19
- Status last verified
- Jul 2022
- First submitted
- 7 Jul 2020
- Last updated
- 20 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reduction of COVID 19 Transmission to Health Care Professionals
- ClinicalTrials.gov ID
- NCT04462627
- Acronym / sponsor ID
- CHUB-BDS-COVID19
- Conditions
- COVID 19
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 566 participants (actual)
- Lead sponsor
- Hanane EL KENZUniversity, hospital or other
- Study start
- 14 Apr 2020 (actual)
- Primary completion
- 11 Apr 2022 (actual)
- Study completion
- 11 Apr 2022 (actual)
- First posted
- 8 Jul 2020 (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.
When the COVID-19 virus infects a person, it enters the lung epithelial cells of its host and uses its genetic material to replicate.
The pulmonary epithelial cells of a part of the population, known as "secretors", are capable of expressing the antigens of the "ABO" system on their surface. This secretory status can be established by determining the antigens of the Lewis blood group system. When the virus replicates in an "secreting" individual, the antigens of the "ABO" system of the infected individual will be present on the surface of the viruses formed in his/her lungs.
It was shown in 2003 that the response of a given individual to the transmission of a virus depends on his/her blood group and on the antigens of the "ABO" system carried by the virus. A patient of group "O" would thus defend himself much better against a virus carrying antigens of blood group "A", the natural antibodies "anti-A" of the patient reducing the ability of the virus to bind to its specific receptor on pulmonary epithelial cells, to penetrate them to replicate itself. The first data collected in Wuhan (China) seems to confirm this hypothesis. A COVID-19 virus transmission model can therefore be established on the basis of blood groups.
In order to reduce the spread of the virus among nursing staff, it is possible to establish a preferential algorithm for patient management based on the "ABO" and "Lewis" blood groups of patients and "ABO" of nursing staff in health care units, if operational and human conditions allow.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Covid 19 positive patients | Experimental | Diagnostic Test: Blood group determination, Diagnostic Test: Antibody titration |
| Covid 19 negative patients | Experimental | Diagnostic Test: Blood group determination, Diagnostic Test: Antibody titration |
| Untested healthy volunteers | Experimental | Diagnostic Test: Blood group determination, Diagnostic Test: Antibody titration, Dietary Supplement: Probiotic |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- COVID19 positive patients admitted within the CHU Brugmann Hospital
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Blood group determinationDetermination of the blood group (ABO/LE) | Diagnostic test | Covid 19 negative patients, Covid 19 positive patients, Untested healthy volunteers |
| Antibody titrationNatural anti-A and anti-B antibody levels will be determined by a gel agglutination technique on the Biorad IH-500 automaton. | Diagnostic test | Covid 19 negative patients, Covid 19 positive patients, Untested healthy volunteers |
| ProbioticAdministration of a probiotic to healthy volunteers to determine if it increases the level of circulating natural anti-A and anti-B antibodies (Probactiol Plus (Metagenics)). | Dietary supplement | Untested healthy volunteers |
Primary outcome
Anti-A antibody concentration
Time frame: baseline
Anti-A antibody titration, as determined by gel agglutination on the Biorad IH-500 automated system.
Anti-A antibody concentration
Time frame: Day 4
Anti-A antibody titration, as determined by gel agglutination on the Biorad IH-500 automated system.
Anti-A antibody concentration
Time frame: Week 1
Anti-A antibody titration, as determined by gel agglutination on the Biorad IH-500 automated system.
Anti-A antibody concentration
Time frame: Week 2
Anti-A antibody titration, as determined by gel agglutination on the Biorad IH-500 automated system.
Anti-A antibody concentration
Time frame: Week 3
Anti-A antibody titration, as determined by gel agglutination on the Biorad IH-500 automated system.
Anti-B antibody concentration
Time frame: baseline
Anti-B antibody titration, as determined by gel agglutination on the Biorad IH-500 automated system.
Anti-B antibody concentration
Time frame: Day 4
Anti-B antibody titration, as determined by gel agglutination on the Biorad IH-500 automated system.
Anti-B antibody concentration
Time frame: Week 1
Anti-B antibody titration, as determined by gel agglutination on the Biorad IH-500 automated system.
Anti-B antibody concentration
Time frame: Week 2
Anti-B antibody titration, as determined by gel agglutination on the Biorad IH-500 automated system.
Anti-B antibody concentration
Time frame: Week 3
Anti-B antibody titration, as determined by gel agglutination on the Biorad IH-500 automated system.
Blood group
Time frame: baseline
Blood group (ABO/LE)
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 20 Jul 2022.
- Individual participant dataSharing planned: No
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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.
Hanane El Kenz, MD principal investigator
CHU Brugmann
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood group determination, Antibody titration and Probiotic in people with COVID 19, run by Hanane EL KENZ at 1 site in Belgium.
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 1 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 20 Jul 2022. 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 Belgium. 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?
Anti-A antibody concentration (time frame: baseline). The study lists 11 primary outcomes in all. 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 20 Jul 2022.