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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04452604
Other study ID # COVLA
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 11, 2020
Est. completion date July 7, 2021

Study information

Verified date July 2022
Source French Innovative Leukemia Organisation
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 79
Est. completion date July 7, 2021
Est. primary completion date June 30, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - 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: 1. 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) 2. Probable infection: negative PCR but association of 1. 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 2. 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 3. absence of differential diagnosis Exclusion Criteria: - None

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
France Chu Amiens Amiens
France CHU ANGERS - Maladies du sang Angers
France Ch Avignon Avignon
France CH de la Côte Basque - Hématologie Bayonne
France CHU Caen - IHBN - Hématologie Clinique Caen
France Centre Hospitalier Sud Francilien Corbeil-essonnes
France Centre Hospitalier de Dunkerque Dunkerque
France CHU de Grenoble - Hopital Michallon Grenoble
France Centre Hospitalier du Mans Le Mans
France Hôpital Saint Vicent de Paul Lille
France Chu Limoges Limoges
France Institut Paoli-Calmettes - Hématologie 2 Marseille
France HOPITAL SAINT ELOI - Hematologie Montpellier
France HOPITAL E. MULLER - Hématologie Mulhouse
France CHU HOTEL DIEU - Hématologie Clinique Nantes
France CHU Caremeau Nîmes
France CENTRE HOSPITALIER SAINTJEAN - Hématologie Clinique Perpignan
France Bordeaux Pessac Pessac
France Centre Hospitalier Lyon Sud Pierre-Bénite
France CHU Reims - Hôpital Robert Debré - Hématologie Clinique Reims
France CHU Pontchaillou - Hématologie Rennes
France Chu de La Reunion - Site Sud Saint-pierre
France Institut de Cancérologie Lucien Neuwirth Saint-Priest-en-Jarez
France Institut Universitaire du Cancer de Toulouse Oncopole - Service d'Hématologie Toulouse
France CHU de Brabois VandÅ“uvre-lès-Nancy
France Centre Hospitalier de Versailles Versailles
France Institut Gustave Roussy Villejuif

Sponsors (3)

Lead Sponsor Collaborator
French Innovative Leukemia Organisation Acute Leukemia French Association, Group for Research in Adult Acute Lymphoblastic Leukemia

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary Biological prognostic factors for infection with COVID-19 neutrophils and lymphocytes count at the time of SARS-COV2 infection Day 0
Primary 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
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