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NCT Number: NCT04422470

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

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).

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Key information

Conditions

Coronavirus Infection and Hematologic Diseases COVID-19 Coronaviridae Infections Coronavirus Infections Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Infections Leukemia Lung Diseases Lymphatic Diseases Lymphoma Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Republican Clinical Hospital of Tatarstan, Kazan', Russia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Non-Interventional Study

Other

Non-interventional study

Primary outcomes

  1. 30-day all-cause mortality

    Time frame: 30 day

    Rate of death from any cause

Secondary outcomes

  1. COVID-19 complications

    Time frame: 30 day

    Rate of COVID-19 complications

  2. ICU admission

    Time frame: 30 day

    Rate of ICU admission

  3. Mechanical ventilation / O2 requirement

    Time frame: 30 day

    Rate of mechanical ventilation / O2 requirement

  4. Relapse or progression of hematologic disease

    Time frame: 30 day, 90 day and 180 day

    Rate of relapse or progression of hematologic disease

  5. Overall survival

    Time frame: 30 day, 90 day and 180 day

    Number of patients alive

  6. Risk factors

    Time frame: 30 day, 90 day and 180 day

    Putative risk factors for the severity and lethality of COVID-19

Sponsors and collaborators

Lead sponsor

National Research Center for Hematology, Russia

Network

Collaborators

  • Enrollme.ru, LLC
  • Foundation for Cancer Research Support (RakFond)

Registry information

Official study title

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

Acronym: CHRONOS19

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Jun 9, 2020
Registry last updated
Jan 26, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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