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COVID-19 Epidemic and Patients With Myeloproliferative Neoplasias (COVIM)

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ClinicalTrials.gov Identifier: NCT04416438
Recruitment Status : Recruiting
First Posted : June 4, 2020
Last Update Posted : August 12, 2020
Sponsor:
Collaborator:
French Intergroup of Myeloproliferative syndromes
Information provided by (Responsible Party):
French Innovative Leukemia Organisation

Study Description
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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.

Condition or disease
Myeloproliferative Neoplasm COVID-19 Infection

Detailed Description:

It is a descriptive, prospective epidemiological study using retrospective patient data, multicenter, non-interventional, carried out in FIM (French Intergroup of Myeloproliferative syndromes) / FILO (French Innovative Leukemia Organization) centers.

This is an exploratory descriptive study in order to put in place as soon as possible a possible strategy for the protection of patients most at risk.

The study will include all consecutive patients with MNP according to the WHO (World Health Organization) classification seen in consultation or teleconsultation over the duration of the study, whether or not they have had a COVID-19 infection.

The collection of clinical data, treatment regimens and survival and death data will be carried out by the investigator or a member of his medical team, after delivering an information note to the patient informing him of the computerized processing of his data, subject to the patient's non-objection.

The diagnosis of asymptomatic COVID 19 will be made on the presence of a positive serology and on the absence of clinical signs on questioning.

The presence of a symptomatic COVID 19 infection will be posed on the presence of clinical signs +/- CT as identified by the practitioner who treated the patient and confirmed or not by a positive PCR and / or a positive serology.

Data collected:

  • Socio-demographic data (gender, date of birth)
  • Description of hemopathy and its treatment
  • Description of COVID-19 infection and its management
  • Biological data: blood count, specific COVID-19 test results if available (PCR, serology).
  • History, comorbidities
  • Evolution of COVID-19 infection and possible specific treatment
Study Design
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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Observational Study of the Impact of the COronaVirus Disease 2019 (COVID-19) Epidemic on Patients With Myeloproliferative Neoplasias
Actual Study Start Date : May 18, 2020
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

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Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Rate of serious coronavirus infection in different MNP patient subgroups [ Time Frame: Through inclusion period, an average of 6 months ]
    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.

  2. Proportion of MNP patients who had COVID-19 infection during the 2020 epidemic. [ Time Frame: Through inclusion period, an average of 6 months ]
    Number of MNP patients who had COVID-19 compared to general population in France

  3. Rate of death of MNP patients who had COVID-19 [ Time Frame: Through study completion, an average of 1 year ]
    Number of MNP patients who died from COVID-19

  4. Rate of passages in intensive care with need for mechanical ventilation [ Time Frame: Through study completion, an average of 1 year ]
    Number of MNP patients hospitalized in intensive care with need for mechanical ventilation


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Refusal to participate in the study
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): NCT04416438


Contacts
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Contact: Jean-Jacques KILADJIAN, Pr 1 42 49 94 94 ext +33 jean-jacques.kiladjian@aphp.fr
Contact: Valerie ROLLAND 4 76 76 50 96 ext +33 VRolland-neyret@chu-grenoble.fr

Locations
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France
Paris Saint Louis Recruiting
Paris, France, 75475
Contact: Jean-Jacques KILADJIAN, Pr    01 42 49 94 94 ext 33    jean-jacques.kiladjian@aphp.fr   
Sponsors and Collaborators
French Innovative Leukemia Organisation
French Intergroup of Myeloproliferative syndromes
Investigators
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Principal Investigator: Jean-Jacques KILADJIAN, Pr FIM
Principal Investigator: Laurence LEGROS, Dr FIM
More Information
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Responsible Party: French Innovative Leukemia Organisation
ClinicalTrials.gov Identifier: NCT04416438    
Other Study ID Numbers: COVIM
First Posted: June 4, 2020    Key Record Dates
Last Update Posted: August 12, 2020
Last Verified: August 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases