Clinical trial NCT04391946: Observatory of Patients With Chronic Lymphocytic Leukemia / Lymphocytic Lymphoma or Waldenstrom Disease Infected With COVID-19
Official title: National Prospective and Retrospective Follow-up of Patients With COVID-19 Infected Chronic Lymphocytic Leukemia / Lymphocytic Lymphoma or Waldenström Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Lymphocytic Leukemia, Lymphocytic Lymphoma or Waldenstrom Disease
Lead sponsor: French Innovative Leukemia Organisation
Sponsor class: OTHER
Collaborators: name: Institut de cancérologie Strasbourg Europe
First posted: 2020-05-18
Enrollment: 162
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: COVID-19 infected patients with chronic lymphocytic leukemia / lymphocytic lymphoma or Waldenström disease

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Prognostic factors for healing of COVID-19 infection
timeFrame: Day 0
Secondary outcomes:
measure: Medical care of Coronavirus infection
timeFrame: within 12 months after diagnosis
measure: national epidemiological monitoring
timeFrame: through study completion, an average of 2 years
Other outcomes:
Locations:
city: Angers
country: France
facility: Chu Angers
city: Besançon
country: France
facility: CHU Jean Minjoz - Hématologie
city: Bobigny
country: France
facility: Hôpital Avicenne - Centre de Recherche Clinique
city: Clermont-Ferrand
country: France
facility: CHU Estaing - Hématologie Clinique Adulte
city: Créteil
country: France
facility: Chu Creteil
city: Grenoble
country: France
facility: CHU Grenoble - Hématologie
city: La Roche-sur-Yon
country: France
facility: Chd Vendee
city: Le Mans
country: France
facility: Centre Hospitalier du Mans
city: Lille
country: France
facility: Hôpital Saint Vicent de Paul
city: Lyon
country: France
facility: Centre Léon Bérard - Hématologie
city: Marseille
country: France
facility: Institut Paoli Calmette
city: Mulhouse
country: France
facility: Hopital E.Muller
city: Nantes
country: France
facility: CHU DE NANTES - Hematologie clinique
city: Paris
country: France
facility: Hopital Pitie Salpetriere Service Hematologie Clinique - Pavillon de L'Enfant Et Adolescent
city: Pierre-Bénite
country: France
facility: Centre Hospitalier Lyon Sud
city: Poitiers
country: France
facility: Hôpital de la Milétrie - Hématologie et Thérapie Cellulaire
city: Reims
country: France
facility: Hôpital Robert Debré - Hématologie Clinique
city: Rouen
country: France
facility: Centre Henri Becquerel - Service Hématologie Clinique
city: Strasbourg
country: France
facility: Hôpital Hautepierre - Hématologie
city: Toulouse
country: France
facility: IUCT ONCOPOLE - Hématologie
city: Tours
country: France
facility: Hôpital Bretonneau - Hématologie et Thérapie Cellulaire
city: Vandœuvre-lès-Nancy
country: France
facility: CHU Nancy Brabois
Study officials:
affiliation: French Innovative Leukemia Organisation
name: Luc-Matthieu FORNECKER, Pr
role: PRINCIPAL_INVESTIGATOR
References: