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NCT Number: NCT04416438

COVID-19 Epidemic and Patients With Myeloproliferative Neoplasias

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.

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Key information

Conditions

Myeloproliferative Neoplasm Bone Marrow Diseases COVID-19 COVID-19 Infection Coronaviridae Infections Coronavirus Infections Hematologic Diseases Hemic and Lymphatic Diseases Infections Lung Diseases Myeloproliferative Disorders Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Paris Saint Louis

Paris, 75475, France

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

French Innovative Leukemia Organisation

Other

Collaborators

  • French Intergroup of Myeloproliferative syndromes

Registry information

Official study title

Observational Study of the Impact of the COronaVirus Disease 2019 (COVID-19) Epidemic on Patients With Myeloproliferative Neoplasias

Acronym: COVIM

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Jun 4, 2020
Registry last updated
Oct 18, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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