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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04452604
Recruitment Status : Not yet recruiting
First Posted : June 30, 2020
Last Update Posted : June 30, 2020
Sponsor:
Collaborators:
Acute Leukemia French Association
Group for Research in Adult Acute Lymphoblastic Leukemia
Information provided by (Responsible Party):
French Innovative Leukemia Organisation

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
Acute Myeloblastic Leukemia Acute Lymphoblastic Leukemia SARS-CoV-2

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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: National Retrospective Monitoring of Patients With Acute Leukemia Infected by COronaVirus Disease 2019 (COVID-19)
Estimated Study Start Date : August 1, 2020
Estimated Primary Completion Date : August 1, 2023
Estimated Study Completion Date : December 1, 2023





Primary Outcome Measures :
  1. Clinical prognostic factors for infection with COVID-19 [ Time Frame: 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)

  2. Biological prognostic factors for infection with COVID-19 [ Time Frame: Day 0 ]
    neutrophils and lymphocytes count at the time of SARS-COV2 infection

  3. Medical care of Coronavirus infection [ Time Frame: 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
COVID-19 infected patients with AML or ALL
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04452604


Contacts
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Contact: Pierre-Yves DUMAS, Dr 0557656514 ext 33 pierre-yves.dumas@chu-bordeaux.fr
Contact: Sarah BERTOLI, Dr bertoli.sarah@iuct-oncopole.fr

Sponsors and Collaborators
French Innovative Leukemia Organisation
Acute Leukemia French Association
Group for Research in Adult Acute Lymphoblastic Leukemia
Investigators
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Principal Investigator: Pierre-Yves DUMAS, Dr French Innovative Leukemia Organisation
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Responsible Party: French Innovative Leukemia Organisation
ClinicalTrials.gov Identifier: NCT04452604    
Other Study ID Numbers: COVLA
First Posted: June 30, 2020    Key Record Dates
Last Update Posted: June 30, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms
Leukemia, Lymphoid
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, Myeloid