COVID-19 Epidemic and Patients With Myeloproliferative Neoplasias

NCT04416438 | Completed

• 1 other identifier: COVIM
• Study Type: observational
• Target: 1,793
• Locations: 1 country
• Sites: 1

Brief Summary

The classic myeloproliferative neoplasias (MNP), including polycythemia vera (PV), essential thrombocythemia (ET), primary myelofibrosis (PMF) or secondary to PV or ET, are among the most frequent of malignant hemopathies, with overall prevalence estimated at around 10,000 patients followed in France. Due to the median age of patients around 65, the frequency of cardiovascular complications of these thrombogenic diseases and the impact of cytoreductive treatments on immune cells, these patients are considered to be at risk of developing forms severe of COVID-19. This study will assess the impact of MNPs on the risk of developing a severe form of COVID-19, identify new risk factors linked to the disease as well as the impact of treatments for MNPs according to their pharmacological class.

Conditions

Myeloproliferative Neoplasm; COVID-19 Infection

Outcome Measures

Primary Outcomes (4)

• Rate of serious coronavirus infection in different MNP patient subgroups

  The crude rate of cumulative incidence of serious infection proven to COVID-19, compared to the population of the same age, same sex, same region of residence during the epidemic period.

  Through inclusion period, an average of 6 months

• Proportion of MNP patients who had COVID-19 infection during the 2020 epidemic.

  Number of MNP patients who had COVID-19 compared to general population in France

  Through inclusion period, an average of 6 months

• Rate of death of MNP patients who had COVID-19

  Number of MNP patients who died from COVID-19

  Through study completion, an average of 1 year

• Rate of passages in intensive care with need for mechanical ventilation

  Number of MNP patients hospitalized in intensive care with need for mechanical ventilation

  Through study completion, an average of 1 year

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with Classic myeloproliferative neoplasias (MPN), including polycythemia vera (PV), essential thrombocythemia (ET), primary myelofibrosis (PMF) or secondary to PV or ET, and infected by COVID-19

You may qualify if:

• Patient with PV, ET, PMF or MF secondary to PV or ET diagnosed before the COVID-19 pandemic
• Seen in consultation or teleconsultation from May 2020 or deceased if the investigator became aware of this death during the study period

You may not qualify if:

• Refusal to participate in the study

Sponsors & Collaborators

• French Innovative Leukemia Organisation: lead
• French Intergroup of Myeloproliferative syndromes: collaborator

Study Sites (1)

Paris Saint Louis

Paris, 75475, France

Location

MeSH Terms

Conditions

Myeloproliferative Disorders; COVID-19

Condition Hierarchy (Ancestors)

Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Jean-Jacques KILADJIAN, Pr

  FIM

  PRINCIPAL INVESTIGATOR

• Laurence LEGROS, Dr

  FIM

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2020
• First Posted: June 4, 2020
• Study Start: May 18, 2020
• Primary Completion: December 31, 2021
• Study Completion: September 1, 2022
• Last Updated: October 18, 2022

Record last verified: 2022-10

Locations

FR (1)