Clinical Epidemiology and Characteristics Of Covid-19 Cases Occurred In A Lymphoma Setting In The First Epidemic Phase (LymphoCov1)

NCT ID: NCT04386512

Last Updated: 2020-08-07

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 89 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-05-15
• Study Completion Date: 2020-07-15

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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Conditions

COVID; Lymphoma

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: RETROSPECTIVE

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

-

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Versailles Hospital

OTHER

Sponsor Role: lead

Responsible Party

Caroline BESSON

investigator MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

CH de Versailles

Le Chesnay, , France

Countries

France

Other Identifiers

P20/12_LymphoCov

Identifier Type: -

Identifier Source: org_study_id