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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04422470
Recruitment Status : Recruiting
First Posted : June 9, 2020
Last Update Posted : November 13, 2020
Sponsor:
Collaborators:
Foundation for Cancer Research Support (RakFond)
Enrollme.ru LLC
Information provided by (Responsible Party):
National Research Center for Hematology, Russia

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
Coronavirus Infection and Hematologic Diseases 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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 6 Months
Official Title: Observational Prospective Cohort Study - Registry of Patients With Hematologic Disease and COVID-19 in Russia (CHRONOS19)
Actual Study Start Date : June 22, 2020
Estimated Primary Completion Date : January 22, 2021
Estimated Study Completion Date : July 22, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Disorders


Intervention Details:
  • Other: Non-interventional study
    Non-interventional study


Primary Outcome Measures :
  1. 30-day all-cause mortality [ Time Frame: 30 day ]
    Rate of death from any cause


Secondary Outcome Measures :
  1. COVID-19 complications [ Time Frame: 30 day ]
    Rate of COVID-19 complications

  2. ICU admission [ Time Frame: 30 day ]
    Rate of ICU admission

  3. Mechanical ventilation / O2 requirement [ Time Frame: 30 day ]
    Rate of mechanical ventilation / O2 requirement

  4. Relapse or progression of hematologic disease [ Time Frame: 30 day, 90 day and 180 day ]
    Rate of relapse or progression of hematologic disease

  5. Overall survival [ Time Frame: 30 day, 90 day and 180 day ]
    Number of patients alive

  6. Risk factors [ Time Frame: 30 day, 90 day and 180 day ]
    Putative risk factors for the severity and lethality of COVID-19



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with blood disease (both malignant and non-malignant) infected with SARS-CoV-2 infection
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04422470


Contacts
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Contact: Olga Gavrilina, MD, PhD +79629745058 dr.gavrilina@mail.ru

Locations
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Russian Federation
Regional Clinical Hospital No1 Recruiting
Ekaterinburg, Russian Federation
Contact: Yulia Sveshnikova    +7 (343) 243-44-02    office@okb1.ru   
Republican Clinical Hospital of Tatarstan Recruiting
Kazan, Russian Federation
Contact: Mikhail A. Kunst    +7 (843) 231-21-19    mz.rkb@tatar.ru   
City Hospital n.a. V.V. Veresaev Recruiting
Moscow, Russian Federation
Contact: Vasily Shuvaev    +7 (499) 450-55-81    gkb81@zdrav.mos.ru   
Clinical Hospital n.a. S.P. Botkin Recruiting
Moscow, Russian Federation
Contact: Vladimir Vorobyev    +7 (499) 490-03-03    morela@mail.ru   
Sub-Investigator: Lev Butaev         
Sub-Investigator: Kamil Kaplanov         
Sub-Investigator: Andrei Petrenko         
National Research Center for Hematology Recruiting
Moscow, Russian Federation
Contact: Olga Gavrilina, MD, PhD    +79629745058    dr.gavrilina@mail.ru   
Sub-Investigator: Anastasia Vasilieva         
Regional Clinical Hospital N.A. Semashko Recruiting
Nizhny Novgorod, Russian Federation
Contact: Olga Samoylova    +7 (831) 438-95-29    official@semashko.nnov.ru   
Regional Hospital Recruiting
Novosibirsk, Russian Federation
Contact: Ekaterina Vorontsova    +7 (383) 315-98-18    gnokb@oblmed.nsk.ru   
Regional Clinical Hospital Recruiting
Omsk, Russian Federation
Contact: Daria Baryshnikova    +7 (3812) 24-12-09    okb_mail@minzdrav.omskportal.ru   
Republican Clinical Hospital No4 Recruiting
Saransk, Russian Federation
Contact: Lubov Gavrilova    +7 (8342) 33-42-52    office@mail.rkb4.ru   
Republic Clinical Hospital n.a. N.A. Semashko Recruiting
Ulan-Ude, Russian Federation
Contact: Oxana Ochirova    +7 (3012) 23-08-16    rkbsemashko@yandex.ru   
Regional Clinical Hospital Recruiting
Vladimir, Russian Federation
Contact: Olga Panteleeva    +7 (4922) 40-71-26    vlad_okb@vladokb.ru   
Regional Clinical Hospital No2 Recruiting
Vladivostok, Russian Federation
Contact: Vitaly Dubov    +7 (423)232-64-07    office@kkb2.ru   
Republican Hospital No1 Recruiting
Yakutsk, Russian Federation
Contact: Lena Terekhova    +7 (4112) 39-51-93    rb1ncm@gov14.ru   
Regional Clinical Hospital Recruiting
Yaroslavl, Russian Federation
Contact: Inessa Toropova    +7 (4852) 58-23-42    okb76@яокб.рф   
Sponsors and Collaborators
National Research Center for Hematology, Russia
Foundation for Cancer Research Support (RakFond)
Enrollme.ru LLC
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Responsible Party: National Research Center for Hematology, Russia
ClinicalTrials.gov Identifier: NCT04422470    
Other Study ID Numbers: CHRONOS19
First Posted: June 9, 2020    Key Record Dates
Last Update Posted: November 13, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Coronavirus Infections
Severe Acute Respiratory Syndrome
Hematologic Diseases
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases