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

Lymphoma Clinical Trial

— LymphoCov1  

Official title:

Épidémiologie Clinique et caractéristiques Des Cas de Covid-19 Survenus Dans un Contexte de Lymphome Lors de la première Phase épidémique

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04386512
• Other study ID #: P20/12_LymphoCov
• Status: Completed
• Start date: May 15, 2020
• Est. completion date: July 15, 2020

Study information

• Verified date: August 2020
• Source: Versailles Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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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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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Recruitment information / eligibility

• Status: Completed
• Enrollment: 89
• Est. completion date: July 15, 2020
• Est. primary completion date: June 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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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Related Conditions & MeSH terms

• COVID
• Lymphoma

Locations

Country	Name	City	State
France	CH de Versailles	Le Chesnay

Sponsors (1)

Lead Sponsor	Collaborator
Versailles Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	mortality		2 months
Primary	transfer to ICU		2 months