Myeloproliferative NeoplasmCOVIMNCT04416438
COVID-19 Epidemic and Patients With Myeloproliferative Neoplasias
An observational study of Myeloproliferative Neoplasm and COVID-19 Infection, run by French Innovative Leukemia Organisation at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myeloproliferative Neoplasm, COVID-19 Infection
- How many people
- 1,793 participants
- Where
- 1 siteFrance
- Study dates
- 18 May 2020to 1 Sep 2022
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- Refusal to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Observational Study of the Impact of the COronaVirus Disease 2019 (COVID-19) Epidemic on 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.
Read the 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
- Conditions
- Myeloproliferative Neoplasm, COVID-19 Infection
- Medical subject headings
- Myeloproliferative Disorders, COVID-19
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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
Measured: 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
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2020
- Study start18 May 2020
- Primary completion31 Dec 2021
- Study completion1 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myeloproliferative NeoplasmStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,793 participants (actual)
Sponsor and investigators
- Lead sponsor
- French Innovative Leukemia Organisation
- Sponsor type
- University, hospital or other
- Collaborators
- French Intergroup of Myeloproliferative syndromes
- Responsible party
- Sponsor
- Investigators
- Jean-Jacques KILADJIAN, Pr, Principal investigator, FIMLaurence LEGROS, Dr, Principal investigator, FIM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04416438
- Sponsor's protocol ID
- COVIM
- Acronym
- COVIM
- Status last verified
- Oct 2022
- First submitted
- 3 Jun 2020
- Last updated
- 18 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study of the Impact of the COronaVirus Disease 2019 (COVID-19) Epidemic on Patients With Myeloproliferative Neoplasias
- ClinicalTrials.gov ID
- NCT04416438
- Acronym / sponsor ID
- COVIM / COVIM
- Conditions
- Myeloproliferative Neoplasm, COVID-19 Infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,793 participants (actual)
- Lead sponsor
- French Innovative Leukemia OrganisationUniversity, hospital or other
- Collaborators
- French Intergroup of Myeloproliferative syndromes
- Study start
- 18 May 2020 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 1 Sep 2022 (actual)
- First posted
- 4 Jun 2020 (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 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.
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
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- Refusal to participate in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2022.
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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.
Jean-Jacques KILADJIAN, Pr principal investigator
FIM
Laurence LEGROS, Dr principal investigator
FIM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myeloproliferative Neoplasm and COVID-19 Infection, run by French Innovative Leukemia Organisation at 1 site in France.
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 2 inclusion and 1 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: finished, as of the sponsor's last update on 18 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of serious coronavirus infection in different MNP patient subgroups (time frame: Through inclusion period, an average of 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Oct 2022.