- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04462627
Reduction of COVID 19 Transmission to Health Care Professionals
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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Brussels, Belgium, 1020
- CHU Brugmann
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- COVID19 positive patients admitted within the CHU Brugmann Hospital
Exclusion Criteria:
- None
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Covid 19 positive patients
|
Determination of the blood group (ABO/LE)
Natural anti-A and anti-B antibody levels will be determined by a gel agglutination technique on the Biorad IH-500 automaton.
|
|
Experimental: Covid 19 negative patients
|
Determination of the blood group (ABO/LE)
Natural anti-A and anti-B antibody levels will be determined by a gel agglutination technique on the Biorad IH-500 automaton.
|
|
Experimental: Untested healthy volunteers
|
Determination of the blood group (ABO/LE)
Natural anti-A and anti-B antibody levels will be determined by a gel agglutination technique on the Biorad IH-500 automaton.
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)).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Anti-A antibody concentration
Time Frame: baseline
|
Anti-A antibody titration, as determined by gel agglutination on the Biorad IH-500 automated system.
|
baseline
|
|
Anti-A antibody concentration
Time Frame: Day 4
|
Anti-A antibody titration, as determined by gel agglutination on the Biorad IH-500 automated system.
|
Day 4
|
|
Anti-A antibody concentration
Time Frame: Week 1
|
Anti-A antibody titration, as determined by gel agglutination on the Biorad IH-500 automated system.
|
Week 1
|
|
Anti-A antibody concentration
Time Frame: Week 2
|
Anti-A antibody titration, as determined by gel agglutination on the Biorad IH-500 automated system.
|
Week 2
|
|
Anti-A antibody concentration
Time Frame: Week 3
|
Anti-A antibody titration, as determined by gel agglutination on the Biorad IH-500 automated system.
|
Week 3
|
|
Anti-B antibody concentration
Time Frame: baseline
|
Anti-B antibody titration, as determined by gel agglutination on the Biorad IH-500 automated system.
|
baseline
|
|
Anti-B antibody concentration
Time Frame: Day 4
|
Anti-B antibody titration, as determined by gel agglutination on the Biorad IH-500 automated system.
|
Day 4
|
|
Anti-B antibody concentration
Time Frame: Week 1
|
Anti-B antibody titration, as determined by gel agglutination on the Biorad IH-500 automated system.
|
Week 1
|
|
Anti-B antibody concentration
Time Frame: Week 2
|
Anti-B antibody titration, as determined by gel agglutination on the Biorad IH-500 automated system.
|
Week 2
|
|
Anti-B antibody concentration
Time Frame: Week 3
|
Anti-B antibody titration, as determined by gel agglutination on the Biorad IH-500 automated system.
|
Week 3
|
|
Blood group
Time Frame: baseline
|
Blood group (ABO/LE)
|
baseline
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Hanane El Kenz, MD, CHU Brugmann
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CHUB-BDS-COVID19
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.