Registry of Patients With Hematologic Disease and COVID-19 in Russia

Study Overview
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Brief Summary
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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
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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.

Official Title
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Observational Prospective Cohort Study - Registry of Patients With Hematologic Disease and COVID-19 in Russia (CHRONOS19)

Conditions
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Coronavirus Infection and Hematologic Diseases

Intervention / Treatment
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* Other: Non-interventional study


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Non-interventional study|Non-interventional study|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 30-day all-cause mortality | Rate of death from any cause | 30 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| COVID-19 complications | Rate of COVID-19 complications | 30 day | 
| ICU admission | Rate of ICU admission | 30 day | 
| Mechanical ventilation / O2 requirement | Rate of mechanical ventilation / O2 requirement | 30 day | 
| Relapse or progression of hematologic disease | Rate of relapse or progression of hematologic disease | 30 day, 90 day and 180 day | 
| Overall survival | Number of patients alive | 30 day, 90 day and 180 day | 
| Risk factors | Putative risk factors for the severity and lethality of COVID-19 | 30 day, 90 day and 180 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Leukemia, COVID-19, Blood diseases, Lymphoma