- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04422470
Registry of Patients With Hematologic Disease and COVID-19 in Russia (CHRONOS19)
January 25, 2023 updated by: National Research Center for Hematology, Russia
Observational Prospective Cohort Study - Registry of Patients With Hematologic Disease and COVID-19 in Russia (CHRONOS19)
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).
Study Overview
Status
Completed
Intervention / Treatment
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 Type
Observational
Enrollment (Actual)
666
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Ekaterinburg, Russian Federation
- Regional Clinical Hospital No1
-
Kazan, Russian Federation
- Republican Clinical Hospital of Tatarstan
-
Moscow, Russian Federation
- National Research Center for Hematology
-
Moscow, 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
-
Nizhny Novgorod, Russian Federation
- Regional Clinical Hospital N.A. Semashko
-
Novosibirsk, Russian Federation
- Regional Hospital
-
Omsk, Russian Federation
- Regional Clinical Hospital
-
Saint Petersburg, Russian Federation, 197022
- RM Gorbacheva Research Institute of Pediatric Oncology, Hematology and Transplantation, Pavlov University
-
Saransk, Russian Federation
- Republican Clinical Hospital No4
-
Ulan-Ude, Russian Federation
- Republic Clinical Hospital n.a. N.A. Semashko
-
Vladimir, Russian Federation
- Regional Clinical Hospital
-
Vladivostok, Russian Federation
- Regional Clinical Hospital №2
-
Yaroslavl, Russian Federation
- Regional Clinical Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients with hematologic disease (both malignant and non-malignant) infected with SARS-CoV-2
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
30-day all-cause mortality
Time Frame: 30 day
|
Rate of death from any cause
|
30 day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
COVID-19 complications
Time Frame: 30 day
|
Rate of COVID-19 complications
|
30 day
|
ICU admission
Time Frame: 30 day
|
Rate of ICU admission
|
30 day
|
Mechanical ventilation / O2 requirement
Time Frame: 30 day
|
Rate of mechanical ventilation / O2 requirement
|
30 day
|
Relapse or progression of hematologic disease
Time Frame: 30 day, 90 day and 180 day
|
Rate of relapse or progression of hematologic disease
|
30 day, 90 day and 180 day
|
Overall survival
Time Frame: 30 day, 90 day and 180 day
|
Number of patients alive
|
30 day, 90 day and 180 day
|
Risk factors
Time Frame: 30 day, 90 day and 180 day
|
Putative risk factors for the severity and lethality of COVID-19
|
30 day, 90 day and 180 day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Chair: Elena Parovichnikova, National Research Center for Hematology
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 22, 2020
Primary Completion (Actual)
August 22, 2021
Study Completion (Actual)
January 18, 2022
Study Registration Dates
First Submitted
June 8, 2020
First Submitted That Met QC Criteria
June 8, 2020
First Posted (Actual)
June 9, 2020
Study Record Updates
Last Update Posted (Actual)
January 26, 2023
Last Update Submitted That Met QC Criteria
January 25, 2023
Last Verified
January 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CHRONOS19
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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