COVLA: Multicentric Registry of Patients With Acute Leukemia Infected by COVID-19
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Study Design
Outcome Measures
Primary Outcome Measures
- Clinical prognostic factors for infection with COVID-19 [Day 0]
Factors associated with overall survival will be analyzed : center, sex, leukemia subtype, previous treatment by corticosteroids, and comorbidities (respiratory, renal, cardiac, weight, diabetes)
- Biological prognostic factors for infection with COVID-19 [Day 0]
neutrophils and lymphocytes count at the time of SARS-COV2 infection
- Medical care of Coronavirus infection [within 12 months after diagnosis]
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
Eligibility Criteria
Criteria
Inclusion Criteria:
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Diagnosis of acute leukemia according to WHO criteria 2016 ≤ 5 years
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Diagnosis of a proven or probable SARS-CoV-2 infection according to the following criteria:
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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)
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Probable infection: negative PCR but association of
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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
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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
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absence of differential diagnosis
Exclusion Criteria:
- None
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Chu Amiens | Amiens | France | 80054 | |
| 2 | CHU ANGERS - Maladies du sang | Angers | France | 49933 | |
| 3 | Ch Avignon | Avignon | France | 84000 | |
| 4 | CH de la Côte Basque - Hématologie | Bayonne | France | 64109 | |
| 5 | CHU Caen - IHBN - Hématologie Clinique | Caen | France | 14033 | |
| 6 | Centre Hospitalier Sud Francilien | Corbeil-essonnes | France | 91100 | |
| 7 | Centre Hospitalier de Dunkerque | Dunkerque | France | ||
| 8 | CHU de Grenoble - Hopital Michallon | Grenoble | France | 38043 | |
| 9 | Centre Hospitalier du Mans | Le Mans | France | 72000 | |
| 10 | Hôpital Saint Vicent de Paul | Lille | France | 59000 | |
| 11 | Chu Limoges | Limoges | France | ||
| 12 | Institut Paoli-Calmettes - Hématologie 2 | Marseille | France | 13000 | |
| 13 | HOPITAL SAINT ELOI - Hematologie | Montpellier | France | 34295 | |
| 14 | HOPITAL E. MULLER - Hématologie | Mulhouse | France | 68070 | |
| 15 | CHU HOTEL DIEU - Hématologie Clinique | Nantes | France | 44093 | |
| 16 | CHU Caremeau | Nîmes | France | 30029 | |
| 17 | CENTRE HOSPITALIER SAINTJEAN - Hématologie Clinique | Perpignan | France | 66000 | |
| 18 | Bordeaux Pessac | Pessac | France | 33604 | |
| 19 | Centre Hospitalier Lyon Sud | Pierre-Bénite | France | 69495 | |
| 20 | CHU Reims - Hôpital Robert Debré - Hématologie Clinique | Reims | France | 51100 | |
| 21 | CHU Pontchaillou - Hématologie | Rennes | France | 35033 | |
| 22 | Chu de La Reunion - Site Sud | Saint-pierre | France | ||
| 23 | Institut de Cancérologie Lucien Neuwirth | Saint-Priest-en-Jarez | France | 42271 | |
| 24 | Institut Universitaire du Cancer de Toulouse Oncopole - Service d'Hématologie | Toulouse | France | 31059 | |
| 25 | CHU de Brabois | Vandœuvre-lès-Nancy | France | 54500 | |
| 26 | Centre Hospitalier de Versailles | Versailles | France | ||
| 27 | Institut Gustave Roussy | Villejuif | France |
Sponsors and Collaborators
- French Innovative Leukemia Organisation
- Acute Leukemia French Association
- Group for Research in Adult Acute Lymphoblastic Leukemia
Investigators
- Principal Investigator: Pierre-Yves DUMAS, Dr, French Innovative Leukemia Organisation
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- COVLA