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

Sponsor
National Research Center for Hematology, Russia (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04422470
Collaborator
Foundation for Cancer Research Support (RakFond) (Other), Enrollme.ru, LLC (Other)
666
Enrollment
15
Locations
18.9
Anticipated Duration (Months)
44.4
Patients Per Site
2.4
Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • Other: Non-interventional study

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 Design

Study Type:
Observational [Patient Registry]
Actual Enrollment :
666 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Observational Prospective Cohort Study - Registry of Patients With Hematologic Disease and COVID-19 in Russia (CHRONOS19)
Actual Study Start Date :
Jun 22, 2020
Actual Primary Completion Date :
Aug 22, 2021
Anticipated Study Completion Date :
Jan 18, 2022

Outcome Measures

Primary Outcome Measures

  1. 30-day all-cause mortality [30 day]

    Rate of death from any cause

Secondary Outcome Measures

  1. COVID-19 complications [30 day]

    Rate of COVID-19 complications

  2. ICU admission [30 day]

    Rate of ICU admission

  3. Mechanical ventilation / O2 requirement [30 day]

    Rate of mechanical ventilation / O2 requirement

  4. Relapse or progression of hematologic disease [30 day, 90 day and 180 day]

    Rate of relapse or progression of hematologic disease

  5. Overall survival [30 day, 90 day and 180 day]

    Number of patients alive

  6. Risk factors [30 day, 90 day and 180 day]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No

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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Regional Clinical Hospital No1 Ekaterinburg Russian Federation
2 Republican Clinical Hospital of Tatarstan Kazan Russian Federation
3 City Hospital n.a. V.V. Veresaev Moscow Russian Federation
4 Clinical Hospital n.a. S.P. Botkin Moscow Russian Federation
5 N.V. Sklifosovsky Emergency Institute Moscow Russian Federation
6 National Research Center for Hematology Moscow Russian Federation
7 Regional Clinical Hospital N.A. Semashko Nizhny Novgorod Russian Federation
8 Regional Hospital Novosibirsk Russian Federation
9 Regional Clinical Hospital Omsk Russian Federation
10 RM Gorbacheva Research Institute of Pediatric Oncology, Hematology and Transplantation, Pavlov University Saint Petersburg Russian Federation 197022
11 Republican Clinical Hospital No4 Saransk Russian Federation
12 Republic Clinical Hospital n.a. N.A. Semashko Ulan-Ude Russian Federation
13 Regional Clinical Hospital Vladimir Russian Federation
14 Regional Clinical Hospital No2 Vladivostok Russian Federation
15 Regional Clinical Hospital Yaroslavl Russian Federation

Sponsors and Collaborators

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

Investigators

  • Study Chair: Valery Savchenko, National Research Center for Hematology

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
National Research Center for Hematology, Russia
ClinicalTrials.gov Identifier:
NCT04422470
Other Study ID Numbers:
  • CHRONOS19
First Posted:
Jun 9, 2020
Last Update Posted:
Oct 21, 2021
Last Verified:
Oct 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by National Research Center for Hematology, Russia
COVID-19
Blood diseases
Leukemia
Lymphoma
Additional relevant MeSH terms:
COVID-19
Coronavirus Infections
Hematologic Diseases

Study Results

No Results Posted as of Oct 21, 2021