COVID-19 Epidemic and Patients With Myeloproliferative Neoplasias (COVIM)
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| ClinicalTrials.gov Identifier: NCT04416438 |
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Recruitment Status :
Active, not recruiting
First Posted : June 4, 2020
Last Update Posted : July 27, 2022
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| Condition or disease |
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| Myeloproliferative Neoplasm COVID-19 Infection |
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 Type : | Observational |
| Actual Enrollment : | 1793 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 |
| Actual Primary Completion Date : | December 31, 2021 |
| Estimated Study Completion Date : | September 1, 2022 |
- 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
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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 |
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
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
| France | |
| Paris Saint Louis | |
| Paris, France, 75475 | |
| Principal Investigator: | Jean-Jacques KILADJIAN, Pr | FIM | |
| Principal Investigator: | Laurence LEGROS, Dr | FIM |
| 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: | July 27, 2022 |
| Last Verified: | July 2022 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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COVID-19 Myeloproliferative Disorders Respiratory Tract Infections Infections Pneumonia, Viral Pneumonia Virus Diseases Coronavirus Infections |
Coronaviridae Infections Nidovirales Infections RNA Virus Infections Lung Diseases Respiratory Tract Diseases Bone Marrow Diseases Hematologic Diseases |