Clinical trial NCT04386512: Clinical Epidemiology and Characteristics Of Covid-19 Cases Occurred In A Lymphoma Setting In The First Epidemic Phase (LymphoCov1)
Official title: Épidémiologie Clinique et caractéristiques Des Cas de Covid-19 Survenus Dans un Contexte de Lymphome Lors de la première Phase épidémique
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID
Lymphoma
Keywords: covid
lymphoma
epidemiology
Lead sponsor: Versailles Hospital
Sponsor class: OTHER
First posted: 2020-05-13
Enrollment: 89
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with a current or past history of lymphoma who were hospitalized with Covid-19 infection between March the 1st and April the 30th in ile de France or Est region in France

Brief summary: The main objective of this retrospective clinical epidemiology study is to describe the characteristics of Covid-19 cases requiring hospitalization in adult patients with lymphomas during the initial phase of the epidemic (from 01/03/20 to 30/04/20).

The specific objectives are to estimate the frequency of severe forms of Covid-19 and those requiring intensive care hospitalisation, as well as the mortality related to the epidemic among the active file of patients followed for lymphoma at each study site, to investigate whether certain chemotherapy and/or immunotherapy treatments seem to be associated with severe forms or prolonged evolutions of Covid-19, to describe possible atypical clinical forms among the population of patients treated for lymphoma.

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Detailed description: I

Methods :

* Multicentric retrospective observational epidemiological study based on the collection of data from patient records.
* Selection of voluntary hospital sites in regions with excess mortality during the epidemic phase.
* Systematic identification of Covid-19 cases from coding data (PMSI) from the medical information departments which will be compared with the numbers of patients followed for lymphoma in the haematology departments of each site during the 6 months preceding the epidemic, identified through the PMSI.
* Establishment of an ad hoc CRF for cases only with collection of clinical data concerning lymphoma and Covid-19 and routine biological data: Cytopenia (and in particular depth of lymphopenia), hypogammaglobulinemia, inflammatory markers.
* Estimated total number of sites: 10-15 and number of cases to be collected: 50-60.

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Eligibility criteria: Inclusion Criteria:

* Patients at least 18 years of age with lymphoma and a diagnosis of Covid-19 requiring hospitalization.
* In order not to bias the data by excluding patients with adverse outcomes, we will also collect data from deceased patients.

Exclusion Criteria:

Patients who refused to participate

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Primary outcomes:
measure: mortality
timeFrame: 2 months
measure: transfer to ICU
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Le Chesnay
country: France
facility: CH de Versailles
Study officials:
References: