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

Sponsor

Versailles Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT04386512

Collaborator

(none)

Enrollment

Location

Actual Duration (Months)

44.4

Patients Per Site Per Month

Study Details

Study Description

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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Condition or Disease	Intervention/Treatment	Phase
COVID Lymphoma

Detailed Description

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 Design

Study Type:

Observational

Actual Enrollment :

89 participants

Observational Model:

Case-Only

Time Perspective:

Retrospective

Official Title:

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

Actual Study Start Date :

May 15, 2020

Actual Primary Completion Date :

Jun 1, 2020

Actual Study Completion Date :

Jul 15, 2020

Outcome Measures

Primary Outcome Measures

mortality [2 months]
transfer to ICU [2 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CH de Versailles	Le Chesnay		France

Sponsors and Collaborators

Versailles Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Caroline BESSON, investigator MD, Versailles Hospital

ClinicalTrials.gov Identifier:

NCT04386512

Other Study ID Numbers:

P20/12_LymphoCov

First Posted:

May 13, 2020

Last Update Posted:

Aug 7, 2020

Last Verified:

Aug 1, 2020

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Caroline BESSON, investigator MD, Versailles Hospital

covid

lymphoma

epidemiology

Additional relevant MeSH terms:

Lymphoma

Study Results

No Results Posted as of Aug 7, 2020