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

January 4, 2022 updated by: Assistance Publique - Hôpitaux de Paris

Severe Acute Respiratory Syndrome CoV 2 Seroprevalence Survey and Vaccination Coverage in the Sickle Cell Population in Ile-De-France

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).

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

880

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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.
Other: 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.
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
9 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

December 30, 2021

Primary Completion (Anticipated)

September 10, 2022

Study Completion (Anticipated)

September 10, 2022

Study Registration Dates

First Submitted

October 28, 2021

First Submitted That Met QC Criteria

December 9, 2021

First Posted (Actual)

December 10, 2021

Study Record Updates

Last Update Posted (Actual)

January 5, 2022

Last Update Submitted That Met QC Criteria

January 4, 2022

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • APHP211232

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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