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Reduction of COVID 19 Transmission to Health Care Professionals

Primary Purpose

COVID 19

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Blood group determination
Antibody titration
Probiotic
Sponsored by
Hanane EL KENZ
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for COVID 19

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • COVID19 positive patients admitted within the CHU Brugmann Hospital

Exclusion Criteria:

  • None

Sites / Locations

  • CHU Brugmann

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Covid 19 positive patients

Covid 19 negative patients

Untested healthy volunteers

Arm Description

Outcomes

Primary Outcome Measures

Anti-A antibody concentration
Anti-A antibody titration, as determined by gel agglutination on the Biorad IH-500 automated system.
Anti-A antibody concentration
Anti-A antibody titration, as determined by gel agglutination on the Biorad IH-500 automated system.
Anti-A antibody concentration
Anti-A antibody titration, as determined by gel agglutination on the Biorad IH-500 automated system.
Anti-A antibody concentration
Anti-A antibody titration, as determined by gel agglutination on the Biorad IH-500 automated system.
Anti-A antibody concentration
Anti-A antibody titration, as determined by gel agglutination on the Biorad IH-500 automated system.
Anti-B antibody concentration
Anti-B antibody titration, as determined by gel agglutination on the Biorad IH-500 automated system.
Anti-B antibody concentration
Anti-B antibody titration, as determined by gel agglutination on the Biorad IH-500 automated system.
Anti-B antibody concentration
Anti-B antibody titration, as determined by gel agglutination on the Biorad IH-500 automated system.
Anti-B antibody concentration
Anti-B antibody titration, as determined by gel agglutination on the Biorad IH-500 automated system.
Anti-B antibody concentration
Anti-B antibody titration, as determined by gel agglutination on the Biorad IH-500 automated system.
Blood group
Blood group (ABO/LE)

Secondary Outcome Measures

Full Information

First Posted
July 7, 2020
Last Updated
July 19, 2022
Sponsor
Hanane EL KENZ
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1. Study Identification

Unique Protocol Identification Number
NCT04462627
Brief Title
Reduction of COVID 19 Transmission to Health Care Professionals
Official Title
Reduction of COVID 19 Transmission to Health Care Professionals
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
April 14, 2020 (Actual)
Primary Completion Date
April 11, 2022 (Actual)
Study Completion Date
April 11, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Hanane EL KENZ

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID 19

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
566 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Covid 19 positive patients
Arm Type
Experimental
Arm Title
Covid 19 negative patients
Arm Type
Experimental
Arm Title
Untested healthy volunteers
Arm Type
Experimental
Intervention Type
Diagnostic Test
Intervention Name(s)
Blood group determination
Intervention Description
Determination of the blood group (ABO/LE)
Intervention Type
Diagnostic Test
Intervention Name(s)
Antibody titration
Intervention Description
Natural anti-A and anti-B antibody levels will be determined by a gel agglutination technique on the Biorad IH-500 automaton.
Intervention Type
Dietary Supplement
Intervention Name(s)
Probiotic
Intervention Description
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)).
Primary Outcome Measure Information:
Title
Anti-A antibody concentration
Description
Anti-A antibody titration, as determined by gel agglutination on the Biorad IH-500 automated system.
Time Frame
baseline
Title
Anti-A antibody concentration
Description
Anti-A antibody titration, as determined by gel agglutination on the Biorad IH-500 automated system.
Time Frame
Day 4
Title
Anti-A antibody concentration
Description
Anti-A antibody titration, as determined by gel agglutination on the Biorad IH-500 automated system.
Time Frame
Week 1
Title
Anti-A antibody concentration
Description
Anti-A antibody titration, as determined by gel agglutination on the Biorad IH-500 automated system.
Time Frame
Week 2
Title
Anti-A antibody concentration
Description
Anti-A antibody titration, as determined by gel agglutination on the Biorad IH-500 automated system.
Time Frame
Week 3
Title
Anti-B antibody concentration
Description
Anti-B antibody titration, as determined by gel agglutination on the Biorad IH-500 automated system.
Time Frame
baseline
Title
Anti-B antibody concentration
Description
Anti-B antibody titration, as determined by gel agglutination on the Biorad IH-500 automated system.
Time Frame
Day 4
Title
Anti-B antibody concentration
Description
Anti-B antibody titration, as determined by gel agglutination on the Biorad IH-500 automated system.
Time Frame
Week 1
Title
Anti-B antibody concentration
Description
Anti-B antibody titration, as determined by gel agglutination on the Biorad IH-500 automated system.
Time Frame
Week 2
Title
Anti-B antibody concentration
Description
Anti-B antibody titration, as determined by gel agglutination on the Biorad IH-500 automated system.
Time Frame
Week 3
Title
Blood group
Description
Blood group (ABO/LE)
Time Frame
baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: COVID19 positive patients admitted within the CHU Brugmann Hospital Exclusion Criteria: None
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hanane El Kenz, MD
Organizational Affiliation
CHU Brugmann
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Brugmann
City
Brussels
ZIP/Postal Code
1020
Country
Belgium

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Reduction of COVID 19 Transmission to Health Care Professionals

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