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Observatory of Patients With Chronic Lymphocytic Leukemia / Lymphocytic Lymphoma or Waldenstrom Disease Infected With COVID-19 (COVID19_LLC-MW)

F

French Innovative Leukemia Organisation

Status

Completed

Conditions

Chronic Lymphocytic Leukemia, Lymphocytic Lymphoma or Waldenstrom Disease

Treatments

Behavioral: Data registry

Study type

Observational

Funder types

Other

Identifiers

NCT04391946
FILO-COVID19_LLC-MW

Details and patient eligibility

About

The COVID-19 epidemic (Coronavirus Disease 2019) which is currently raging in France is an emerging infectious disease linked to a virus of the genus coronavirus (SARS-CoV-2). The first cases were reported in Wuhan, China, in late December 2019 [1]. Globally, it has been placed in the "pandemic" stage by the WHO since March 11, 2020. Coronavirus viruses have been responsible for epidemics in the past such as the SARS epidemic in 2002 (Syndrome Severe Acute Respiratory) linked to the SARS-CoV virus, or the epidemic of MERS (Middle East Respiratory Syndrome) that affected the Middle East in 2012.

Patients with chronic lymphocytic leukemia (CLL) / lymphocytic lymphoma or Waldenstrom Disease (WD) therefore represent a population at high risk of developing a severe form in the event of COVID-19 infection.

To date, no data is available in the literature to assess the impact of the COVID-19 epidemic in this population of patients with CLL / lymphocytic lymphoma or WD.

Enrollment

162 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Diagnosis of chronic lymphocytic leukemia / lymphocytic lymphoma or Waldenstrom disease according to the criteria of the WHO 2016 with a proven or probable infection by COVID-19 according to the following criteria:

  • Proven infection: PCR positive regardless of the radio-clinical picture (Other tests made available later and having good diagnostic performance will be accepted)

  • Probable infection: the diagnosis of probable infection is retained in case of negative PCR or not made if presence of at least 2 major criteria or of a major criterion associated with at least 2 minor criteria among the following, in the absence other documented cause.

  • Major criteria:

    • Fever
    • Loss of smell / taste
    • At least one respiratory sign among cough, dyspnea, chest pain
    • Radiological signs suggestive of the scanner (areas or diffuse appearance of frosted glass, condensations including pseudonodular condensations, association of frosted glass and condensation within the same lesion, nodules and micronodules, thickening of the interlobular septa) or on an X-ray of the thorax ( interstitial, alveolo-interstitial or alveolar syndrome, unilateral or bilateral)
    • Notion of storytelling with a person whose SARS-CoV-2 infection has been formally documented
  • Minor criteria

    • Aches
    • Sore throat
    • Rhinorrhea
    • Headache
    • Diarrhea
    • Abdominal pain
    • Frank asthenia
    • Conjunctivitis

Exclusion criteria

  • Patient opposition

Trial contacts and locations

22

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Data sourced from clinicaltrials.gov

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