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

Completed

• Conditions: COVID; Lymphoma

• Registration Number: NCT04386512
• Lead Sponsor: Versailles Hospital

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

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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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Study Timeline

• Study First Submitted: 2020-05-12
• Study First Submitted QC: 2020-05-12
• Study First Posted: 2020-05-13
• Study Start: 2020-05-15
• Primary Completion: 2020-06-01
• Study Completion: 2020-07-15
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-06
• Last Update Posted: 2020-08-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 89

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
mortality	2 months
transfer to ICU	2 months

Trial Locations

Locations (1)

CH de Versailles; 🇫🇷 Le Chesnay, France