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
- Tel. +49 (0) 221 478-4400
- Fax +49 (0) 221 478-5455
- studien-innere1@uk-koeln.de
Dr. Jon Salmanton-García
Monitoring
Klinik I für Innere Medizin
- Tel. +49 (0) 221 478-4400
- Fax +49 (0) 221 478-5455
- studien-innere1@uk-koeln.de
Dr. Jon Salmanton-García
Data management
Klinik I für Innere Medizin
- Tel. +49 (0) 221 478-4400
- Fax +49 (0) 221 478-5455
- studien-innere1@uk-koeln.de
Dr. Jon Salmanton-García
Database development
Klinik I für Innere Medizin
- Tel. +49 (0) 221 478-4400
- Fax +49 (0) 221 478-5455
- studien-innere1@uk-koeln.de
Dr. Jon Salmanton-García
Statistics
Klinik I für Innere Medizin
- Tel. +49 (0) 221 478-4400
- Fax +49 (0) 221 478-5455
- studien-innere1@uk-koeln.de
Dr. Jon Salmanton-García