NCT05153044

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).

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
880

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2021

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 28, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 10, 2021

Completed
20 days until next milestone

Study Start

First participant enrolled

December 30, 2021

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 10, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 10, 2022

Completed
Last Updated

January 5, 2022

Status Verified

September 1, 2021

Enrollment Period

8 months

First QC Date

October 28, 2021

Last Update Submit

January 4, 2022

Conditions

Sickle Cell Disease

Keywords

seroprevalenceSARS-CoV-2sickle cell

Outcome Measures

Primary Outcomes (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).

    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 Outcomes (7)

  • The positivity anti-SARS-CoV-2 serology and anti-spike antibody titre from M0 to M6.

    9 months

  • Negativity of anti-SARS-CoV-2 serology at M3 and M6.

    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).

    9 months

  • Intensive care unit admission for COVID-19.

    9 months

  • Proportion of patients vaccinated among the patients interviewed and included in the study.

    9 months

  • +2 more secondary outcomes

Study Arms (4)

sickle cell children group

OTHER

sickle cell children group

Other: severe acute respiratory syndrome CoV-2 serology

sickle cell adult group

OTHER

sickle cell adult group

Other: severe acute respiratory syndrome CoV-2 serology

control children group

OTHER

control children group

Other: severe acute respiratory syndrome CoV-2 serology

Vaccinated patients

NO INTERVENTION

Vaccinated patients

Interventions

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.

control children groupsickle cell adult groupsickle cell children group

Eligibility Criteria

Age1 Year+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patient group = children with sickle cell disease:
  • 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 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 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
  • +1 more criteria

You may not qualify if:

  • Patient group = sickle cell children :
  • Infants under 12 months of age.
  • Other haemoglobinopathies and heterozygous Haemoglobin AS or AC patients.
  • Children on state medical assistance
  • Adult sickle cell group :
  • Other haemoglobinopathies and heterozygous AS or AC patients.
  • 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 on state medical assistance

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • 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.

    PMID: 33131239BACKGROUND

  • 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.

    PMID: 33289008BACKGROUND

  • 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.

    PMID: 33115920BACKGROUND

MeSH Terms

Conditions

Anemia, Sickle Cell

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, CongenitalAnemia, HemolyticAnemiaHematologic DiseasesHemic and Lymphatic DiseasesHemoglobinopathiesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Luu-Ly PHAM, Dr

CONTACT

01 48 02 44 05luu-ly.pham@aphp.fr

Houda ALLALOU

CONTACT

0148957407houda.allalou@aphp.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 28, 2021

First Posted

December 10, 2021

Study Start

December 30, 2021

Primary Completion

September 10, 2022

Study Completion

September 10, 2022

Last Updated

January 5, 2022

Record last verified: 2021-09