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Multicentric Registry of Patients With Acute Leukemia Infected by COVID-19

National Retrospective Monitoring of Patients With Acute Leukemia Infected by COronaVirus Disease 2019 (COVID-19)

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04452604
Acronym
COVLA
Enrollment
79
Registered
2020-06-30
Start date
2020-09-11
Completion date
2021-07-07
Last updated
2022-07-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Lymphoblastic Leukemia, Acute Myeloblastic Leukemia, SARS-CoV-2

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.

Interventions

None listed

Sponsors

Acute Leukemia French Association
CollaboratorOTHER
Group for Research in Adult Acute Lymphoblastic Leukemia
CollaboratorOTHER
French Innovative Leukemia Organisation
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Clinical prognostic factors for infection with COVID-19Day 0Factors 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-19Day 0neutrophils and lymphocytes count at the time of SARS-COV2 infection
Medical care of Coronavirus infectionwithin 12 months after diagnosisDescribe 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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026