Severe Acute Respiratory Syndrome CoV 2 COVID-19 Survey and Vaccination Coverage in the Sickle Cell Population in Ile-De-France (COVIDO-DREP)
Primary Purpose
Sickle Cell Disease
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
severe acute respiratory syndrome CoV-2 serology
Sponsored by
About this trial
This is an interventional other trial for Sickle Cell Disease focused on measuring seroprevalence, SARS-CoV-2, sickle cell
Eligibility Criteria
Inclusion Criteria:
- Patient group = children with sickle cell disease:
- Children over 12 months of age and under 18 at the time of inclusion.
- Children with a major sickle cell syndrome (SS, "C gene and one sickle hemoglobin (S) gene", Sβ+, Sβ°, SE) followed in one of the centers of competence or reference for rare diseases (CRMR) "Major Sickle Cell Syndromes, Thalassemias and Other Rare Pathologies of Red Blood Cell and Erythropoiesis "from Ile de France.
- Children not subject to legal protection measures.
- Children affiliated to a French social security scheme
- Informed consent signed by one of the two parents.
Group of adults with sickle cell disease:
- Patients over 18 years of age at the time of inclusion (male, female).
- Patients with a major sickle cell syndrome (SS, "C gene and one sickle hemoglobin (S) gene", Sβ+, Sβ°, SE) followed in one of the centers of competence or reference for rare diseases (CRMR) "Major Sickle Cell Syndromes, Thalassemias and Other Rare Pathologies of Red Blood Cell and Erythropoiesis "from Ile de France.
- Patients not subject to legal protection measures.
- Patients affiliated to a French social security scheme
- Informed consent signed
Child-control group:
- Children over 12 months old and under 18 years old at the time of inclusion.
- Children without sickle cell disease
- Children monitored for asthma or with a history of asthma.
- Children not subject to legal protection measures.
- Children affiliated to a French social security scheme
- Informed consent signed by one of the two parents.
Exclusion Criteria:
- Patient group = sickle cell children :
- Infants under 12 months of age.
- Other haemoglobinopathies and heterozygous Haemoglobin AS or AC patients.
- Children already in a treatment protocol or in the exclusion period from a previous investigation.
- Children on state medical assistance
Adult sickle cell group :
- Other haemoglobinopathies and heterozygous AS or AC patients.
- Patients already on a treatment protocol or in the exclusion period from a previous investigation.
- Pregnant or lactating women.
- Patients on state medical assistance
Child control group :
- Infants under 12 months of age and adults over 18 years of age.
- Children already in a treatment protocol or in the exclusion period from a previous study.
- Children on state medical assistance
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Other
Other
Other
No Intervention
Arm Label
sickle cell children group
sickle cell adult group
control children group
Vaccinated patients
Arm Description
sickle cell children group
sickle cell adult group
control children group
Vaccinated patients
Outcomes
Primary Outcome Measures
The positivity of total anti-SARS-CoV-2 blood Ig will be determined by the presence of anti-spike protein Ig G and / or anti-nucleocapsid Ig G (post-infectious COVID-19 humoral immunity).
To determine the seroprevalence of SARS-CoV-2 after the 4th epidemic wave in unvaccinated sickle cell patients (children and adults), living in an area with high viral circulation of SARS-CoV-2 and high risk of viral transmission, in Ile-De-France.
Secondary Outcome Measures
The positivity anti-SARS-CoV-2 serology and anti-spike antibody titre from M0 to M6.
Compare the seroprevalence and decrease in antibodies (initial M0 titre and duration of persistence at M3-M6) in unvaccinated patients with a history of COVID-19 infection between the group of children with sickle cell disease, the group of children non-sickle cell control patients and the group of adults with sickle cell disease.
Negativity of anti-SARS-CoV-2 serology at M3 and M6.
Investigation of factors associated with a faster loss of anti-SARS-CoV-2 blood antibodies (age, sex, genotype, splenectomy, transplants, treatment with hydroxyurea) in unvaccinated sickle cell patients with a history of COVID-19 infection.
COVID-19 infection (nasopharyngeal RT-PCR Reverse transcription-polymerase chain reaction positivity and/or COVID-19 anti-SARS-CoV-2 serology).
Assessing factors associated with the risk of COVID-19 infection (epidemiological, environmental and sickle cell disease related) in sickle cell patients.
Intensive care unit admission for COVID-19.
Assessing factors associated with a severe form of COVID-19 infection among sickle cell patients.
Proportion of patients vaccinated among the patients interviewed and included in the study.
Determine the vaccination coverage rate of the sickle cell population (according to age groups) over a period of 3 months, after the 4th epidemic wave of 2021.
Occurrence of post-vaccine side effects (fever, pain, vaso-occlusive crisis, myocarditis, others)
List the occurrence of declared side effects.
Proportion of COVID-19 infection occurring in vaccinated patients.
Determine the incidence rate of COVID-19 infection in vaccinated patients (vaccine failure rate)
Full Information
NCT ID
NCT05153044
First Posted
October 28, 2021
Last Updated
January 4, 2022
Sponsor
Assistance Publique - Hôpitaux de Paris
1. Study Identification
Unique Protocol Identification Number
NCT05153044
Brief Title
Severe Acute Respiratory Syndrome CoV 2 COVID-19 Survey and Vaccination Coverage in the Sickle Cell Population in Ile-De-France
Acronym
COVIDO-DREP
Official Title
Severe Acute Respiratory Syndrome CoV 2 Seroprevalence Survey and Vaccination Coverage in the Sickle Cell Population in Ile-De-France
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
December 30, 2021 (Anticipated)
Primary Completion Date
September 10, 2022 (Anticipated)
Study Completion Date
September 10, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
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
The objective of this study is to determine the seroprevalence of severe acute respiratory syndrome-CoV-2 in unvaccinated sickle cell patients living in an area with high viral circulation and at risk of high viral transmission, after the 4th epidemic wave of COVID-19 in Ile-de -France, over a period of 3 months (for example, last quarter of 2021).
Detailed Description
Sickle cell disease is a very widespread genetic disease affecting 300,000 births worldwide, with a prevalence of one affected child for 1736 births in France, the most common genetic disease in France. France is the European country with the highest prevalence of the disease while Ile-de-France is the region with the highest prevalence of sickle cell disease and COVID-19. The medical management of sickle cell patients raises many challenges related to the complexity of their disease and the comorbidities that may be associated with their conditions (arterial hypertension, pulmonary arterial hypertension, nephropathy and renal failure, cerebral vasculopathy).Our seroprevalence study will focus on the sickle cell population living in an area with high circulation of severe acute respiratory syndrome-CoV-2; it will start after the 4th epidemic wave of COVID-19 during the vaccination campaigns, in order to collect on the one hand seroprevalence data (proportion of unvaccinated seropositive sickle cell patients) and persistence of humoral immunity (quantitative) after infection in unvaccinated subjects and on the other hand, to assess the vaccination coverage in this specific population (adults and adolescents) as well as its impact (occurrence of vaccine failures).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sickle Cell Disease
Keywords
seroprevalence, SARS-CoV-2, sickle cell
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
880 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
sickle cell children group
Arm Type
Other
Arm Description
sickle cell children group
Arm Title
sickle cell adult group
Arm Type
Other
Arm Description
sickle cell adult group
Arm Title
control children group
Arm Type
Other
Arm Description
control children group
Arm Title
Vaccinated patients
Arm Type
No Intervention
Arm Description
Vaccinated patients
Intervention Type
Other
Intervention Name(s)
severe acute respiratory syndrome CoV-2 serology
Intervention Description
diagnostic serology of severe acute respiratory syndrome-CoV-2 infection performed during the inclusion visit Regarding follow-up visits, only seropositive patients will be called for sampling, for serological follow-up at 3 months then 6 months.
Primary Outcome Measure Information:
Title
The positivity of total anti-SARS-CoV-2 blood Ig will be determined by the presence of anti-spike protein Ig G and / or anti-nucleocapsid Ig G (post-infectious COVID-19 humoral immunity).
Description
To determine the seroprevalence of SARS-CoV-2 after the 4th epidemic wave in unvaccinated sickle cell patients (children and adults), living in an area with high viral circulation of SARS-CoV-2 and high risk of viral transmission, in Ile-De-France.
Time Frame
9 months
Secondary Outcome Measure Information:
Title
The positivity anti-SARS-CoV-2 serology and anti-spike antibody titre from M0 to M6.
Description
Compare the seroprevalence and decrease in antibodies (initial M0 titre and duration of persistence at M3-M6) in unvaccinated patients with a history of COVID-19 infection between the group of children with sickle cell disease, the group of children non-sickle cell control patients and the group of adults with sickle cell disease.
Time Frame
9 months
Title
Negativity of anti-SARS-CoV-2 serology at M3 and M6.
Description
Investigation of factors associated with a faster loss of anti-SARS-CoV-2 blood antibodies (age, sex, genotype, splenectomy, transplants, treatment with hydroxyurea) in unvaccinated sickle cell patients with a history of COVID-19 infection.
Time Frame
3 and 6 months
Title
COVID-19 infection (nasopharyngeal RT-PCR Reverse transcription-polymerase chain reaction positivity and/or COVID-19 anti-SARS-CoV-2 serology).
Description
Assessing factors associated with the risk of COVID-19 infection (epidemiological, environmental and sickle cell disease related) in sickle cell patients.
Time Frame
9 months
Title
Intensive care unit admission for COVID-19.
Description
Assessing factors associated with a severe form of COVID-19 infection among sickle cell patients.
Time Frame
9 months
Title
Proportion of patients vaccinated among the patients interviewed and included in the study.
Description
Determine the vaccination coverage rate of the sickle cell population (according to age groups) over a period of 3 months, after the 4th epidemic wave of 2021.
Time Frame
9 months
Title
Occurrence of post-vaccine side effects (fever, pain, vaso-occlusive crisis, myocarditis, others)
Description
List the occurrence of declared side effects.
Time Frame
9 months
Title
Proportion of COVID-19 infection occurring in vaccinated patients.
Description
Determine the incidence rate of COVID-19 infection in vaccinated patients (vaccine failure rate)
Time Frame
9 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Year
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Patient group = children with sickle cell disease:
Children over 12 months of age and under 18 at the time of inclusion.
Children with a major sickle cell syndrome (SS, "C gene and one sickle hemoglobin (S) gene", Sβ+, Sβ°, SE) followed in one of the centers of competence or reference for rare diseases (CRMR) "Major Sickle Cell Syndromes, Thalassemias and Other Rare Pathologies of Red Blood Cell and Erythropoiesis "from Ile de France.
Children not subject to legal protection measures.
Children affiliated to a French social security scheme
Informed consent signed by one of the two parents.
Group of adults with sickle cell disease:
Patients over 18 years of age at the time of inclusion (male, female).
Patients with a major sickle cell syndrome (SS, "C gene and one sickle hemoglobin (S) gene", Sβ+, Sβ°, SE) followed in one of the centers of competence or reference for rare diseases (CRMR) "Major Sickle Cell Syndromes, Thalassemias and Other Rare Pathologies of Red Blood Cell and Erythropoiesis "from Ile de France.
Patients not subject to legal protection measures.
Patients affiliated to a French social security scheme
Informed consent signed
Child-control group:
Children over 12 months old and under 18 years old at the time of inclusion.
Children without sickle cell disease
Children monitored for asthma or with a history of asthma.
Children not subject to legal protection measures.
Children affiliated to a French social security scheme
Informed consent signed by one of the two parents.
Exclusion Criteria:
Patient group = sickle cell children :
Infants under 12 months of age.
Other haemoglobinopathies and heterozygous Haemoglobin AS or AC patients.
Children already in a treatment protocol or in the exclusion period from a previous investigation.
Children on state medical assistance
Adult sickle cell group :
Other haemoglobinopathies and heterozygous AS or AC patients.
Patients already on a treatment protocol or in the exclusion period from a previous investigation.
Pregnant or lactating women.
Patients on state medical assistance
Child control group :
Infants under 12 months of age and adults over 18 years of age.
Children already in a treatment protocol or in the exclusion period from a previous study.
Children on state medical assistance
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Luu-Ly PHAM, Dr
Phone
01 48 02 44 05
Email
luu-ly.pham@aphp.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Houda ALLALOU
Phone
0148957407
Email
houda.allalou@aphp.fr
12. IPD Sharing Statement
Citations:
PubMed Identifier
33131239
Citation
Menapace LA, Thein SL. COVID-19 and sickle cell disease. Haematologica. 2020 Nov 1;105(11):2501-2504. doi: 10.3324/haematol.2020.255398. No abstract available.
Results Reference
background
PubMed Identifier
33289008
Citation
Vilela TS, Braga JAP, Loggetto SR. Hemoglobinopathy and pediatrics in the time of COVID-19. Hematol Transfus Cell Ther. 2021 Jan-Mar;43(1):87-100. doi: 10.1016/j.htct.2020.11.002. Epub 2020 Dec 2.
Results Reference
background
PubMed Identifier
33115920
Citation
Wajnberg A, Amanat F, Firpo A, Altman DR, Bailey MJ, Mansour M, McMahon M, Meade P, Mendu DR, Muellers K, Stadlbauer D, Stone K, Strohmeier S, Simon V, Aberg J, Reich DL, Krammer F, Cordon-Cardo C. Robust neutralizing antibodies to SARS-CoV-2 infection persist for months. Science. 2020 Dec 4;370(6521):1227-1230. doi: 10.1126/science.abd7728. Epub 2020 Oct 28.
Results Reference
background
Learn more about this trial
Severe Acute Respiratory Syndrome CoV 2 COVID-19 Survey and Vaccination Coverage in the Sickle Cell Population in Ile-De-France
We'll reach out to this number within 24 hrs