Coronavirus Infection and Hematologic Diseases
Conditions
Keywords
COVID-19, Blood diseases, Leukemia, Lymphoma
Brief summary
This is an observational prospective cohort study to evaluate the clinical course and outcomes of COVID-19 and the underlying disease in patients with hematologic disease (malignant or non-malignant).
Detailed description
This is a web-based registry. After registration, physicians from hematology clinical centers and hospitals in Russia will receive access to the web platform for clinical trial management to fill in the online data collection form in a de-identified manner. This form includes questions about general clinical history of hematologic disease, manifestation, treatment, and the course of COVID-19, concomitant conditions, consequences on the hematologic disease, short-term and long-term outcomes. It will take approximately 10 min to answer the questions. Patients will be followed for 30 days after COVID-19 diagnosis and up to 6 months for hematologic disease outcomes and overall survival assessment.
Interventions
OTHERNon-interventional study
Non-interventional study
Sponsors
Foundation for Cancer Research Support (RakFond)
Enrollme.ru, LLC
National Research Center for Hematology, Russia
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age 18 or older * Any previously or currently diagnosed hematologic disease * Laboratory confirmed or suspected (based on clinical symptoms and/or CT) COVID-19 * Known outcome of COVID-19 in case of retrospective data input (protocol allows retrospective data input for patients who were prospectively followed in local centers)
Exclusion criteria
• Loss of follow-up within 30 days after COVID-19 diagnosis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 30-day all-cause mortality | 30 day | Rate of death from any cause |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ICU admission | 30 day | Rate of ICU admission |
| Mechanical ventilation / O2 requirement | 30 day | Rate of mechanical ventilation / O2 requirement |
| COVID-19 complications | 30 day | Rate of COVID-19 complications |
| Overall survival | 30 day, 90 day and 180 day | Number of patients alive |
| Risk factors | 30 day, 90 day and 180 day | Putative risk factors for the severity and lethality of COVID-19 |
| Relapse or progression of hematologic disease | 30 day, 90 day and 180 day | Rate of relapse or progression of hematologic disease |
Countries
Russia
Outcome results
None listed