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Severe Acute Respiratory Syndrome CoV 2 COVID-19 Survey and Vaccination Coverage in the Sickle Cell Population in Ile-De-France (COVIDO-DREP)

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ClinicalTrials.gov Identifier: NCT05153044
Recruitment Status : Not yet recruiting
First Posted : December 10, 2021
Last Update Posted : January 5, 2022
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Study Description
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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).

Condition or disease Intervention/treatment Phase
Sickle Cell Disease Other: severe acute respiratory syndrome CoV-2 serology Not Applicable

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).
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 880 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Severe Acute Respiratory Syndrome CoV 2 Seroprevalence Survey and Vaccination Coverage in the Sickle Cell Population in Ile-De-France
Estimated Study Start Date : December 30, 2021
Estimated Primary Completion Date : September 10, 2022
Estimated Study Completion Date : September 10, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
sickle cell children group
sickle cell children group
 Other: severe acute respiratory syndrome CoV-2 serology
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.
sickle cell adult group
sickle cell adult group
 Other: severe acute respiratory syndrome CoV-2 serology
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.
control children group
control children group
 Other: severe acute respiratory syndrome CoV-2 serology
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.
No Intervention: Vaccinated patients
Vaccinated patients


Outcome Measures
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Primary Outcome Measures :
  1. 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). [ Time Frame: 9 months ]
    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 :
  1. The positivity anti-SARS-CoV-2 serology and anti-spike antibody titre from M0 to M6. [ Time Frame: 9 months ]
    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.

  2. Negativity of anti-SARS-CoV-2 serology at M3 and M6. [ Time Frame: 3 and 6 months ]
    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.

  3. COVID-19 infection (nasopharyngeal RT-PCR Reverse transcription-polymerase chain reaction positivity and/or COVID-19 anti-SARS-CoV-2 serology). [ Time Frame: 9 months ]
    Assessing factors associated with the risk of COVID-19 infection (epidemiological, environmental and sickle cell disease related) in sickle cell patients.

  4. Intensive care unit admission for COVID-19. [ Time Frame: 9 months ]
    Assessing factors associated with a severe form of COVID-19 infection among sickle cell patients.

  5. Proportion of patients vaccinated among the patients interviewed and included in the study. [ Time Frame: 9 months ]
    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.

  6. Occurrence of post-vaccine side effects (fever, pain, vaso-occlusive crisis, myocarditis, others) [ Time Frame: 9 months ]
    List the occurrence of declared side effects.

  7. Proportion of COVID-19 infection occurring in vaccinated patients. [ Time Frame: 9 months ]
    Determine the incidence rate of COVID-19 infection in vaccinated patients (vaccine failure rate)


Eligibility Criteria
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Ages Eligible for Study:   1 Year and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05153044


Contacts
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Contact: Luu-Ly PHAM, Dr 01 48 02 44 05 luu-ly.pham@aphp.fr
Contact: Houda ALLALOU 0148957407 houda.allalou@aphp.fr

Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
More Information
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Publications:

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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT05153044    
Other Study ID Numbers: APHP211232
First Posted: December 10, 2021    Key Record Dates
Last Update Posted: January 5, 2022
Last Verified: September 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Assistance Publique - Hôpitaux de Paris:
seroprevalence
SARS-CoV-2
sickle cell
Additional relevant MeSH terms:
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Severe Acute Respiratory Syndrome
Anemia, Sickle Cell
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn
 Respiratory Tract Infections
Infections
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Diseases