NCT04462627

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
566

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 14, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 7, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 8, 2020

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 11, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 11, 2022

Completed
Last Updated

July 20, 2022

Status Verified

July 1, 2022

Enrollment Period

2 years

First QC Date

July 7, 2020

Last Update Submit

July 19, 2022

Conditions

Outcome Measures

Primary Outcomes (11)

  • Anti-A antibody concentration

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

    baseline

  • Anti-A antibody concentration

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

    Day 4

  • Anti-A antibody concentration

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

    Week 1

  • Anti-A antibody concentration

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

    Week 2

  • Anti-A antibody concentration

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

    Week 3

  • Anti-B antibody concentration

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

    baseline

  • Anti-B antibody concentration

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

    Day 4

  • Anti-B antibody concentration

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

    Week 1

  • Anti-B antibody concentration

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

    Week 2

  • Anti-B antibody concentration

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

    Week 3

  • Blood group

    Blood group (ABO/LE)

    baseline

Study Arms (3)

Covid 19 positive patients

EXPERIMENTAL
Diagnostic Test: Blood group determinationDiagnostic Test: Antibody titration

Covid 19 negative patients

EXPERIMENTAL
Diagnostic Test: Blood group determinationDiagnostic Test: Antibody titration

Untested healthy volunteers

EXPERIMENTAL
Diagnostic Test: Blood group determinationDiagnostic Test: Antibody titrationDietary Supplement: Probiotic

Interventions

Determination of the blood group (ABO/LE)

Covid 19 negative patientsCovid 19 positive patientsUntested healthy volunteers
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.

Covid 19 negative patientsCovid 19 positive patientsUntested healthy volunteers
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)).

Untested healthy volunteers

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • COVID19 positive patients admitted within the CHU Brugmann Hospital

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Brugmann

Brussels, 1020, Belgium

Location

MeSH Terms

Conditions

COVID-19

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Dietary SupplementsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Hanane El Kenz, MD

    CHU Brugmann

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Head Physician of the Blood Bank

Study Record Dates

First Submitted

July 7, 2020

First Posted

July 8, 2020

Study Start

April 14, 2020

Primary Completion

April 11, 2022

Study Completion

April 11, 2022

Last Updated

July 20, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations