Multicentric Registry of Patients With Acute Leukemia Infected by COVID-19
COVLA
National Retrospective Monitoring of Patients With Acute Leukemia Infected by COronaVirus Disease 2019 (COVID-19)
1 other identifier
observational
79
1 country
27
Brief Summary
The COVID-19 epidemic (Coronavirus Disease 2019) currently raging in France is an emerging infectious disease linked to a virus of the genus coronavirus (SARS-CoV-2). Epidemiologically, acute myeloblastic leukemias (AML) are the most common of acute leukemias. The incidence of acute lymphoblastic leukemia (ALL) is 900 new cases in France in 2018, of which 57% in humans. The treatments administered to AML and ALL patients induce variable immunosuppression: neutropenia, neuropathy, deficits in humoral or cellular immunity or combinations of these deficits. Patients with AML or ALL therefore represent a population at high risk of developing a serious form in the event of infection with SARS-CoV-2. To date, no data is available in the literature to assess the impact of the COVID-19 epidemic in the population of patients with acute leukemia. The main objective of the study is to determine the clinical and biological prognostic factors during SARS-CoV-2 infection in patients with acute leukemia.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Sep 2020
Shorter than P25 for all trials
27 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 18, 2020
CompletedFirst Posted
Study publicly available on registry
June 30, 2020
CompletedStudy Start
First participant enrolled
September 11, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
July 7, 2021
CompletedJuly 27, 2022
July 1, 2022
10 months
June 18, 2020
July 26, 2022
Conditions
Outcome Measures
Primary Outcomes (3)
Clinical prognostic factors for infection with COVID-19
Factors associated with overall survival will be analyzed : center, sex, leukemia subtype, previous treatment by corticosteroids, and comorbidities (respiratory, renal, cardiac, weight, diabetes)
Day 0
Biological prognostic factors for infection with COVID-19
neutrophils and lymphocytes count at the time of SARS-COV2 infection
Day 0
Medical care of Coronavirus infection
Describe the management carried out concerning coronavirus infection and its impact of the treatment of acute leukemia (non-invasive ventilation, orotracheal intubation, vasopressor requiring, treatments used, cause of death
within 12 months after diagnosis
Eligibility Criteria
COVID-19 infected patients with AML or ALL
You may qualify if:
- Diagnosis of acute leukemia according to WHO criteria 2016 ≤ 5 years
- Diagnosis of a proven or probable SARS-CoV-2 infection according to the following criteria:
- Proven infection: positive Polymerase Chain Reaction (PCR) regardless of the radio-clinical picture (other tests made available later and having good diagnostic performance will be accepted)
- Probable infection: negative PCR but association of
- Evocative clinical signs, of recent installation: fever, respiratory signs (cough, dyspnea, chest pain), body aches, sore throat, rhinorrhea, headache, diarrhea / abdominal pain, frank asthenia, loss of taste / smell, conjunctivitis, type of frostbite AND
- evocative radiological signs, on CT: diffuse or diffuse aspect of frosted glass, condensations including pseudo-nodular condensations, association of frosted glass and condensation within the same lesion, nodules and micronodules, thickening of the interlobular septa) or on chest radiography: interstitial, alveolo-interstitial or alveolar syndrome, single or bilateral AND
- absence of differential diagnosis
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (27)
Chu Amiens
Amiens, 80054, France
CHU ANGERS - Maladies du sang
Angers, 49933, France
Ch Avignon
Avignon, 84000, France
CH de la Côte Basque - Hématologie
Bayonne, 64109, France
CHU Caen - IHBN - Hématologie Clinique
Caen, 14033, France
Centre Hospitalier Sud Francilien
Corbeil-Essonnes, 91100, France
Centre Hospitalier de Dunkerque
Dunkirk, France
CHU de Grenoble - Hopital Michallon
Grenoble, 38043, France
Centre Hospitalier du Mans
Le Mans, 72000, France
Hôpital Saint Vicent de Paul
Lille, 59000, France
Chu Limoges
Limoges, France
Institut Paoli-Calmettes - Hématologie 2
Marseille, 13000, France
HOPITAL SAINT ELOI - Hematologie
Montpellier, 34295, France
HOPITAL E. MULLER - Hématologie
Mulhouse, 68070, France
CHU HOTEL DIEU - Hématologie Clinique
Nantes, 44093, France
CHU Caremeau
Nîmes, 30029, France
CENTRE HOSPITALIER SAINTJEAN - Hématologie Clinique
Perpignan, 66000, France
Bordeaux Pessac
Pessac, 33604, France
Centre Hospitalier Lyon Sud
Pierre-Bénite, 69495, France
CHU Reims - Hôpital Robert Debré - Hématologie Clinique
Reims, 51100, France
CHU Pontchaillou - Hématologie
Rennes, 35033, France
Chu de La Reunion - Site Sud
Saint-Pierre, France
Institut de Cancérologie Lucien Neuwirth
Saint-Priest-en-Jarez, 42271, France
Institut Universitaire du Cancer de Toulouse Oncopole - Service d'Hématologie
Toulouse, 31059, France
CHU de Brabois
Vandœuvre-lès-Nancy, 54500, France
Centre Hospitalier de Versailles
Versailles, France
Institut Gustave Roussy
Villejuif, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Pierre-Yves DUMAS, Dr
French Innovative Leukemia Organisation
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 18, 2020
First Posted
June 30, 2020
Study Start
September 11, 2020
Primary Completion
June 30, 2021
Study Completion
July 7, 2021
Last Updated
July 27, 2022
Record last verified: 2022-07
Data Sharing
- IPD Sharing
- Will not share