Sickle Cell DiseaseCOVIDO-DREPNCT05153044
Severe Acute Respiratory Syndrome CoV 2 COVID-19 Survey and Vaccination Coverage in the Sickle Cell Population in Ile-De-France
A study testing severe acute respiratory syndrome CoV-2 serology in people with Sickle Cell Disease, run by Assistance Publique - Hôpitaux de Paris.
Trial 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… Read more about this study
- Who is it for?
- Ages 1 year and olderHealthy volunteers can take part
- Conditions the study is for
- Sickle Cell Disease
- What is being tested?
- severe acute respiratory syndrome CoV-2 serology
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 880 participants
- Where
- No sites listed yet
- Study dates
- 30 Dec 2021to 10 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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 :
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- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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).
Read the 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).
- Conditions
- Sickle Cell Disease
- Being tested
- severe acute respiratory syndrome CoV-2 serology
- Keywords
- seroprevalence, SARS-CoV-2, sickle cell
- Medical subject headings
- Anemia, Sickle Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
severe acute respiratory syndrome CoV-2 serologyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| sickle cell children group | Other | sickle cell children group Receives: Other: severe acute respiratory syndrome CoV-2 serology |
| sickle cell adult group | Other | sickle cell adult group Receives: Other: severe acute respiratory syndrome CoV-2 serology |
| control children group | Other | control children group Receives: Other: severe acute respiratory syndrome CoV-2 serology |
| Vaccinated patients | No intervention | Vaccinated patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 9 months
Secondary outcomes (7)
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.
Measured: 9 months
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.
Measured: 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).
Assessing factors associated with the risk of COVID-19 infection (epidemiological, environmental and sickle cell disease related) in sickle cell patients.
Measured: 9 months
Intensive care unit admission for COVID-19.
Assessing factors associated with a severe form of COVID-19 infection among sickle cell patients.
Measured: 9 months
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.
Measured: 9 months
Occurrence of post-vaccine side effects (fever, pain, vaso-occlusive crisis, myocarditis, others)
List the occurrence of declared side effects.
Measured: 9 months
Proportion of COVID-19 infection occurring in vaccinated patients.
Determine the incidence rate of COVID-19 infection in vaccinated patients (vaccine failure rate)
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2021
- Study start30 Dec 2021 (estimated)
- Primary completion10 Sep 2022 (estimated)
- Study completion10 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Sickle Cell DiseaseStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 880 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05153044
- Sponsor's protocol ID
- APHP211232
- Acronym
- COVIDO-DREP
- Status last verified
- Sep 2021
- First submitted
- 28 Oct 2021
- Last updated
- 5 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 33131239Vilela 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.
PubMed 33289008Wajnberg 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.
PubMed 33115920
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Severe Acute Respiratory Syndrome CoV 2 Seroprevalence Survey and Vaccination Coverage in the Sickle Cell Population in Ile-De-France
- ClinicalTrials.gov ID
- NCT05153044
- Acronym / sponsor ID
- COVIDO-DREP / APHP211232
- Conditions
- Sickle Cell Disease
- Keywords
- seroprevalence, SARS-CoV-2, sickle cell
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 880 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 30 Dec 2021 (estimated)
- Primary completion
- 10 Sep 2022 (estimated)
- Study completion
- 10 Sep 2022 (estimated)
- First posted
- 10 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| sickle cell children group | Other | Other: severe acute respiratory syndrome CoV-2 serologysickle cell children group |
| sickle cell adult group | Other | Other: severe acute respiratory syndrome CoV-2 serologysickle cell adult group |
| control children group | Other | Other: severe acute respiratory syndrome CoV-2 serologycontrol children group |
| Vaccinated patients | No intervention | –Vaccinated patients |
Who may qualify
- Ages
- 1 year and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (19 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| severe acute respiratory syndrome CoV-2 serologydiagnostic 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, sickle cell adult group, sickle cell children group |
Primary outcome
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.
7 secondary outcomes
The positivity anti-SARS-CoV-2 serology and anti-spike antibody titre from M0 to M6.
Time frame: 9 months
Negativity of anti-SARS-CoV-2 serology at M3 and M6.
Time frame: 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
Intensive care unit admission for COVID-19.
Time frame: 9 months
Proportion of patients vaccinated among the patients interviewed and included in the study.
Time frame: 9 months
Occurrence of post-vaccine side effects (fever, pain, vaso-occlusive crisis, myocarditis, others)
Time frame: 9 months
Proportion of COVID-19 infection occurring in vaccinated patients.
Time frame: 9 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2022.
- Background: PubMed 33131239Menapace 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.
- Background: PubMed 33289008Vilela 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.
- Background: PubMed 33115920Wajnberg 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing severe acute respiratory syndrome CoV-2 serology in people with Sickle Cell Disease, run by Assistance Publique - Hôpitaux de Paris.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Luu-Ly PHAM, Dr (01 48 02 44 05, luu-ly.pham@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05153044, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2022.