Clinical trial NCT04422470: Registry of Patients With Hematologic Disease and COVID-19 in Russia
Official title: Observational Prospective Cohort Study - Registry of Patients With Hematologic Disease and COVID-19 in Russia (CHRONOS19)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronavirus Infection and Hematologic Diseases
Keywords: COVID-19
Blood diseases
Leukemia
Lymphoma
Lead sponsor: National Research Center for Hematology, Russia
Sponsor class: NETWORK
Collaborators: name: Foundation for Cancer Research Support (RakFond)
name: Enrollme.ru, LLC
First posted: 2020-06-09
Enrollment: 666
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with hematologic disease (both malignant and non-malignant) infected with SARS-CoV-2

Brief 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).

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.

Eligibility criteria: 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

Primary outcomes:
measure: 30-day all-cause mortality
timeFrame: 30 day
Secondary outcomes:
measure: COVID-19 complications
timeFrame: 30 day
measure: ICU admission
timeFrame: 30 day
measure: Mechanical ventilation / O2 requirement
timeFrame: 30 day
measure: Relapse or progression of hematologic disease
timeFrame: 30 day, 90 day and 180 day
measure: Overall survival
timeFrame: 30 day, 90 day and 180 day
measure: Risk factors
timeFrame: 30 day, 90 day and 180 day
Other outcomes:
Locations:
city: Ekaterinburg
country: Russian Federation
facility: Regional Clinical Hospital No1
city: Kazan
country: Russian Federation
facility: Republican Clinical Hospital of Tatarstan
city: Moscow
country: Russian Federation
facility: City Hospital n.a. V.V. Veresaev
city: Moscow
country: Russian Federation
facility: Clinical Hospital n.a. S.P. Botkin
city: Moscow
country: Russian Federation
facility: N.V. Sklifosovsky Emergency Institute
city: Moscow
country: Russian Federation
facility: National Research Center for Hematology
city: Nizhny Novgorod
country: Russian Federation
facility: Regional Clinical Hospital N.A. Semashko
city: Novosibirsk
country: Russian Federation
facility: Regional Hospital
city: Omsk
country: Russian Federation
facility: Regional Clinical Hospital
city: Saint Petersburg
country: Russian Federation
facility: RM Gorbacheva Research Institute of Pediatric Oncology, Hematology and Transplantation, Pavlov University
city: Saransk
country: Russian Federation
facility: Republican Clinical Hospital No4
city: Ulan-Ude
country: Russian Federation
facility: Republic Clinical Hospital n.a. N.A. Semashko
city: Vladimir
country: Russian Federation
facility: Regional Clinical Hospital
city: Vladivostok
country: Russian Federation
facility: Regional Clinical Hospital No2
city: Yaroslavl
country: Russian Federation
facility: Regional Clinical Hospital
Study officials:
affiliation: National Research Center for Hematology
name: Elena Parovichnikova
role: STUDY_CHAIR
References: