Registry of Patients With Hematologic Disease and COVID-19 in Russia (CHRONOS19)

January 25, 2023 updated by: National Research Center for Hematology, Russia

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

666

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Russian Federation
      • Ekaterinburg, Russian Federation
        • Regional Clinical Hospital No1
      • Kazan, Russian Federation
        • Republican Clinical Hospital of Tatarstan
      • Moscow, Russian Federation
        • National Research Center for Hematology
      • Moscow, Russian Federation
        • City Hospital n.a. V.V. Veresaev
      • Moscow, Russian Federation
        • Clinical Hospital n.a. S.P. Botkin
      • Moscow, Russian Federation
        • N.V. Sklifosovsky Emergency Institute
      • Nizhny Novgorod, Russian Federation
        • Regional Clinical Hospital N.A. Semashko
      • Novosibirsk, Russian Federation
        • Regional Hospital
      • Omsk, Russian Federation
        • Regional Clinical Hospital
      • Saint Petersburg, Russian Federation, 197022
        • RM Gorbacheva Research Institute of Pediatric Oncology, Hematology and Transplantation, Pavlov University
      • Saransk, Russian Federation
        • Republican Clinical Hospital No4
      • Ulan-Ude, Russian Federation
        • Republic Clinical Hospital n.a. N.A. Semashko
      • Vladimir, Russian Federation
        • Regional Clinical Hospital
      • Vladivostok, Russian Federation
        • Regional Clinical Hospital №2
      • Yaroslavl, Russian Federation
        • Regional Clinical Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with hematologic disease (both malignant and non-malignant) infected with SARS-CoV-2

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Research Center for Hematology, Russia

Collaborators

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

Investigators

  • Study Chair: Elena Parovichnikova, National Research Center for Hematology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 22, 2020

Primary Completion (Actual)

August 22, 2021

Study Completion (Actual)

January 18, 2022

Study Registration Dates

First Submitted

June 8, 2020

First Submitted That Met QC Criteria

June 8, 2020

First Posted (Actual)

June 9, 2020

Study Record Updates

Last Update Posted (Actual)

January 26, 2023

Last Update Submitted That Met QC Criteria

January 25, 2023

Last Verified

January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHRONOS19

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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