Status:
COMPLETED
Observatory of Patients With Chronic Lymphocytic Leukemia / Lymphocytic Lymphoma or Waldenstrom Disease Infected With COVID-19
Lead Sponsor:
French Innovative Leukemia Organisation
Collaborating Sponsors:
Institut de cancérologie Strasbourg Europe
Conditions:
Chronic Lymphocytic Leukemia, Lymphocytic Lymphoma or Waldenstrom Disease
Eligibility:
All Genders
18+ years
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 rep...
Eligibility Criteria
Inclusion
- 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
- Patient opposition
Key Trial Info
Start Date :
March 14 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 10 2023
Estimated Enrollment :
162 Patients enrolled
Trial Details
Trial ID
NCT04391946
Start Date
March 14 2020
End Date
March 10 2023
Last Update
May 24 2023
Active Locations (22)
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1
Chu Angers
Angers, France, 49933
2
CHU Jean Minjoz - Hématologie
Besançon, France, 25000
3
Hôpital Avicenne - Centre de Recherche Clinique
Bobigny, France, 93009
4
CHU Estaing - Hématologie Clinique Adulte
Clermont-Ferrand, France, 63000