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OpenTrials
Completed

NCT Number: NCT04391946

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

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Data registry

Behavioral

Collection of clinical data, treatment regimens and survival data

Primary outcomes

  1. Prognostic factors for healing of COVID-19 infection

    Time frame: Day 0

    Hematological pathology Description

Secondary outcomes

  1. Medical care of Coronavirus infection

    Time frame: within 12 months after diagnosis

    Describe the management carried out concerning Coronavirus infection and its impact on the treatment of hemopathy.

  2. national epidemiological monitoring

    Time frame: through study completion, an average of 2 years

    Allow national epidemiological monitoring and regularly inform the hematology community.

Sponsors and collaborators

Lead sponsor

French Innovative Leukemia Organisation

Other

Collaborators

  • Institut de cancérologie Strasbourg Europe

Registry information

Official study title

National Prospective and Retrospective Follow-up of Patients With COVID-19 Infected Chronic Lymphocytic Leukemia / Lymphocytic Lymphoma or Waldenström Disease

Acronym: COVID19_LLC-MW

Important dates

Study start
2020
Primary completion
2022
Study completion
2023
First posted
May 18, 2020
Registry last updated
May 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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