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CompletedNCT04462627Updated Jul 20, 2022

Reduction of COVID 19 Transmission to Health Care Professionals

An interventional study of Blood group determination and Antibody titration in COVID 19, sponsored by Hanane EL KENZ. Completed at 1 site in Belgium. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-07-20.

Sponsored by Hanane EL KENZ · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
566
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • COVID 19

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03

In context

COVID-19

7,990 studies on the registry are indexed under COVID-19; 466 are open to participants now.

This study's enrollment of 566 is above the median of 102 across 4,364 interventional studies indexed under COVID-19.

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Lead sponsor

Hanane EL KENZ is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • COVID19 positive patients admitted within the CHU Brugmann Hospital

Exclusion criteria

Exclusion Criteria:

  • None
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
566 participants (actual)

Study arms

  • Experimental
    Covid 19 positive patients

    Diagnostic Test: Blood group determination · Diagnostic Test: Antibody titration

  • Experimental
    Covid 19 negative patients

    Diagnostic Test: Blood group determination · Diagnostic Test: Antibody titration

  • Experimental
    Untested healthy volunteers

    Diagnostic Test: Blood group determination · Diagnostic Test: Antibody titration · Dietary Supplement: Probiotic

Interventions

  • Diagnostic testBlood group determination

    Determination of the blood group (ABO/LE)

  • Diagnostic testAntibody titration

    Natural anti-A and anti-B antibody levels will be determined by a gel agglutination technique on the Biorad IH-500 automaton.

  • Dietary supplementProbiotic

    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)).

06

What researchers measure

Primary outcomes

  1. Anti-A antibody concentration

    Anti-A antibody titration, as determined by gel agglutination on the Biorad IH-500 automated system.

    Time frame: baseline

  2. Anti-A antibody concentration

    Anti-A antibody titration, as determined by gel agglutination on the Biorad IH-500 automated system.

    Time frame: Day 4

  3. Anti-A antibody concentration

    Anti-A antibody titration, as determined by gel agglutination on the Biorad IH-500 automated system.

    Time frame: Week 1

  4. Anti-A antibody concentration

    Anti-A antibody titration, as determined by gel agglutination on the Biorad IH-500 automated system.

    Time frame: Week 2

  5. Anti-A antibody concentration

    Anti-A antibody titration, as determined by gel agglutination on the Biorad IH-500 automated system.

    Time frame: Week 3

  6. Anti-B antibody concentration

    Anti-B antibody titration, as determined by gel agglutination on the Biorad IH-500 automated system.

    Time frame: baseline

  7. Anti-B antibody concentration

    Anti-B antibody titration, as determined by gel agglutination on the Biorad IH-500 automated system.

    Time frame: Day 4

  8. Anti-B antibody concentration

    Anti-B antibody titration, as determined by gel agglutination on the Biorad IH-500 automated system.

    Time frame: Week 1

  9. Anti-B antibody concentration

    Anti-B antibody titration, as determined by gel agglutination on the Biorad IH-500 automated system.

    Time frame: Week 2

  10. Anti-B antibody concentration

    Anti-B antibody titration, as determined by gel agglutination on the Biorad IH-500 automated system.

    Time frame: Week 3

  11. Blood group

    Blood group (ABO/LE)

    Time frame: baseline

07

Study locations

1 site
  • CHU Brugmann
    Brussels, 1020, Belgium
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 20, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04462627
Lead sponsor
Hanane EL KENZ
Responsible party
Hanane EL KENZ (Head Physician of the Blood Bank, Brugmann University Hospital) — Sponsor-investigator
First posted
Jul 8, 2020
Start date
Apr 14, 2020
Primary completion
Apr 11, 2022
Completion
Apr 11, 2022
Last update
Jul 20, 2022

Study contacts

Hanane El Kenz, MD
principal investigator · CHU Brugmann

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Probiotic

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