Status Acronym ISRCTN EudraCT NCT (clinicaltrials.gov) DRKS
Active EPICOVIDEHA NCT04733729

EPICOVIDEHA - Epidemiology of COVID-19 infection in patients with hematological malignancies: A European Haematology Association Survey

Purpose / Objectives

Primary Outcome

To assess the epidemiology and outcomes of patients with HM infected of COVID-19

disease

Secondary Outcomes

  • To estimate the incidence and type of COVID-19 disease (i.e. symptomatic, asymptomatic).
  • To evaluate admission to ICU.
  • To estimate the frequency of pre-existing co-morbidities.
  • To evaluate acute mortality rate (within 30 days from diagnosis of COVID-19).
  • To estimate the rate of overall case-fatality rate.
  • To assess the spatial-geographical patterns of disease.
  • To stratify patients per off-therapy/on-therapy, per type of therapy (chemo,

    immunotherapy, cell therapy, stem cell transplant)

Diagnosis

  • COVID-19 infection
  • Hämatoonkologische Erkrankungen (English name missing)

Target population

Age

18-

Inclusion criteria

  • Age equal to or greater than 18 years of age.
  • History of hematological malignancies (acute leukemias, myelodysplastic syndromes, myeloproliferative neoplasms, lymphomas, myeloma, chronic myeloprolipherative disorders) at any stage/status.
  • Active hematological malignancies at any stage/status.
  • Diagnosis of hematological malignancy (acute leukemias, myelodysplastic syndromes, myeloproliferative neoplasms, lymphomas, myeloma, chronic myeloprolipherative disorders) at any stage/status.
  • SARS-CoV-2 positive test (nasopharyngeal, BAL, fecal), documented by Real-Time Reverse Transcriptase (RT)-PCR Diagnostic Panels.

Exclusion criteria

  • Hematological diseases, other than hematological malignancies.
  • Not tested positive for SARS-CoV-2
  • Patients “off therapy” for more than 5 years

Study design

  • Multicenter
  • Prospective
  • Cross-over

Documents (password protected)

Responsibilities in overall study

Sponsor

Gilead Sciences, Inc.

(National) Coordinating Investigator

Prof. Livio Pagano

Project management

Klinik I für Innere Medizin

Dr. Jon Salmanton-García

Monitoring

Klinik I für Innere Medizin

Dr. Jon Salmanton-García

Data management

Klinik I für Innere Medizin

Dr. Jon Salmanton-García

Database development

Klinik I für Innere Medizin

Dr. Jon Salmanton-García

Statistics

Klinik I für Innere Medizin

Dr. Jon Salmanton-García