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

NCT ID: NCT04422470

Last Updated: 2023-01-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

666 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-06-22

Study Completion Date

2022-01-18

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.

Conditions

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Coronavirus Infection and Hematologic Diseases

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Non-interventional study

Non-interventional study

Intervention Type OTHER

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Foundation for Cancer Research Support (RakFond)

UNKNOWN

Sponsor Role collaborator

Enrollme.ru, LLC

NETWORK

Sponsor Role collaborator

National Research Center for Hematology, Russia

NETWORK

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Elena Parovichnikova

Role: STUDY_CHAIR

National Research Center for Hematology

Locations

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Republican Clinical Hospital of Tatarstan

Kazan', , Russia

Site Status

City Hospital n.a. V.V. Veresaev

Moscow, , Russia

Site Status

Clinical Hospital n.a. S.P. Botkin

Moscow, , Russia

Site Status

N.V. Sklifosovsky Emergency Institute

Moscow, , Russia

Site Status

National Research Center for Hematology

Moscow, , Russia

Site Status

Regional Clinical Hospital N.A. Semashko

Nizhny Novgorod, , Russia

Site Status

Regional Hospital

Novosibirsk, , Russia

Site Status

Regional Clinical Hospital

Omsk, , Russia

Site Status

RM Gorbacheva Research Institute of Pediatric Oncology, Hematology and Transplantation, Pavlov University

Saint Petersburg, , Russia

Site Status

Republican Clinical Hospital No4

Saransk, , Russia

Site Status

Republic Clinical Hospital n.a. N.A. Semashko

Ulan-Ude, , Russia

Site Status

Regional Clinical Hospital

Vladimir, , Russia

Site Status

Regional Clinical Hospital No2

Vladivostok, , Russia

Site Status

Regional Clinical Hospital

Yaroslavl, , Russia

Site Status

Regional Clinical Hospital No1

Yekaterinburg, , Russia

Site Status

Countries

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Russia

Other Identifiers

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CHRONOS19

Identifier Type: -

Identifier Source: org_study_id

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