search
Back to results

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
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Sickle Cell Disease focused on measuring seroprevalence, SARS-CoV-2, sickle cell

Eligibility Criteria

1 Year - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

    First Posted
    October 28, 2021
    Last Updated
    January 4, 2022
    Sponsor
    Assistance Publique - Hôpitaux de Paris
    search

    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