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

Coronavirus Infection and Hematologic Diseases Clinical Trial

— CHRONOS19  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04422470
• Other study ID #: CHRONOS19
• Status: Completed
• Start date: June 22, 2020
• Est. completion date: January 18, 2022

Study information

• Verified date: January 2022
• Source: National Research Center for Hematology, Russia
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 666
• Est. completion date: January 18, 2022
• Est. primary completion date: August 22, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronavirus Infection and Hematologic Diseases
• Coronavirus Infections
• COVID-19
• Hematologic Diseases

Intervention

Other:
• Non-interventional study
Non-interventional study

Locations

Country	Name	City	State
Russian Federation	Regional Clinical Hospital No1	Ekaterinburg
Russian Federation	Republican Clinical Hospital of Tatarstan	Kazan
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	Moscow
Russian Federation	National Research Center for Hematology	Moscow
Russian Federation	Regional Clinical Hospital N.A. Semashko	Nizhny Novgorod
Russian Federation	Regional Hospital	Novosibirsk
Russian Federation	Regional Clinical Hospital	Omsk
Russian Federation	RM Gorbacheva Research Institute of Pediatric Oncology, Hematology and Transplantation, Pavlov University	Saint Petersburg
Russian Federation	Republican Clinical Hospital No4	Saransk
Russian Federation	Republic Clinical Hospital n.a. N.A. Semashko	Ulan-Ude
Russian Federation	Regional Clinical Hospital	Vladimir
Russian Federation	Regional Clinical Hospital No2	Vladivostok
Russian Federation	Regional Clinical Hospital	Yaroslavl

Sponsors (3)

Lead Sponsor	Collaborator
National Research Center for Hematology, Russia	Enrollme.ru, LLC, Foundation for Cancer Research Support (RakFond)

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	30-day all-cause mortality	Rate of death from any cause	30 day
Secondary	COVID-19 complications	Rate of COVID-19 complications	30 day
Secondary	ICU admission	Rate of ICU admission	30 day
Secondary	Mechanical ventilation / O2 requirement	Rate of mechanical ventilation / O2 requirement	30 day
Secondary	Relapse or progression of hematologic disease	Rate of relapse or progression of hematologic disease	30 day, 90 day and 180 day
Secondary	Overall survival	Number of patients alive	30 day, 90 day and 180 day
Secondary	Risk factors	Putative risk factors for the severity and lethality of COVID-19	30 day, 90 day and 180 day