Coronavirus Infection and Hematologic DiseasesCHRONOS19NCT04422470
Registry of Patients With Hematologic Disease and COVID-19 in Russia
An observational study of Coronavirus Infection and Hematologic Diseases, run by National Research Center for Hematology, Russia at 15 sites in Russia.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronavirus Infection and Hematologic Diseases
- What is being tested?
- Non-interventional study
- How many people
- 666 participants
- Where
- 15 sitesRussia
- Study dates
- 22 Jun 2020to 18 Jan 2022
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with hematologic disease (both malignant and non-malignant) infected with SARS-CoV-2
Who may be able to join
- 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)
Who cannot join
- Loss of follow-up within 30 days after COVID-19 diagnosis
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
Russia15 sites
Republican Clinical Hospital of Tatarstan
Kazan'
City Hospital n.a. V.V. Veresaev
Moscow
Clinical Hospital n.a. S.P. Botkin
Moscow
N.V. Sklifosovsky Emergency Institute
Moscow
National Research Center for Hematology
Moscow
Regional Clinical Hospital N.A. Semashko
Nizhny Novgorod
Regional Hospital
Novosibirsk
Regional Clinical Hospital
Omsk
RM Gorbacheva Research Institute of Pediatric Oncology, Hematology and Transplantation, Pavlov University
Saint Petersburg, 197022
Republican Clinical Hospital No4
Saransk
Republic Clinical Hospital n.a. N.A. Semashko
Ulan-Ude
Regional Clinical Hospital
Vladimir
Regional Clinical Hospital No2
Vladivostok
Regional Clinical Hospital
Yaroslavl
Regional Clinical Hospital No1
Yekaterinburg
About this study
Official title: 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).
Read the 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.
- Being tested
- Non-interventional study
- Keywords
- COVID-19, Blood diseases, Leukemia, Lymphoma
- Medical subject headings
- Coronavirus Infections, Hematologic Diseases, COVID-19, Leukemia, Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-interventional studyOther
Non-interventional study
What is being measured
The primary outcome is the main question the study is designed to answer.
30-day all-cause mortality
Rate of death from any cause
Measured: 30 day
Secondary outcomes (6)
COVID-19 complications
Rate of COVID-19 complications
Measured: 30 day
ICU admission
Rate of ICU admission
Measured: 30 day
Mechanical ventilation / O2 requirement
Rate of mechanical ventilation / O2 requirement
Measured: 30 day
Relapse or progression of hematologic disease
Rate of relapse or progression of hematologic disease
Measured: 30 day, 90 day and 180 day
Overall survival
Number of patients alive
Measured: 30 day, 90 day and 180 day
Risk factors
Putative risk factors for the severity and lethality of COVID-19
Measured: 30 day, 90 day and 180 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2020
- Study start22 Jun 2020
- Primary completion22 Aug 2021
- Study completion18 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronavirus Infection and Hematologic DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 666 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- National Research Center for Hematology, Russia
- Sponsor type
- Research network
- Collaborators
- Foundation for Cancer Research Support (RakFond), Enrollme.ru, LLC
- Responsible party
- Sponsor
- Investigators
- Elena Parovichnikova, Study chair, National Research Center for Hematology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04422470
- Sponsor's protocol ID
- CHRONOS19
- Acronym
- CHRONOS19
- Status last verified
- Jan 2022
- First submitted
- 8 Jun 2020
- Last updated
- 26 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Prospective Cohort Study - Registry of Patients With Hematologic Disease and COVID-19 in Russia (CHRONOS19)
- ClinicalTrials.gov ID
- NCT04422470
- Acronym / sponsor ID
- CHRONOS19 / CHRONOS19
- Keywords
- COVID-19, Blood diseases, Leukemia, Lymphoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 666 participants (actual)
- Lead sponsor
- National Research Center for Hematology, RussiaResearch network
- Collaborators
- Foundation for Cancer Research Support (RakFond), Enrollme.ru, LLC
- Study start
- 22 Jun 2020 (actual)
- Primary completion
- 22 Aug 2021 (actual)
- Study completion
- 18 Jan 2022 (actual)
- First posted
- 9 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with hematologic disease (both malignant and non-malignant) infected with SARS-CoV-2
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (1 listed)
- Loss of follow-up within 30 days after COVID-19 diagnosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-interventional studyNon-interventional study | Other | – |
Primary outcome
30-day all-cause mortality
Time frame: 30 day
Rate of death from any cause
6 secondary outcomes
COVID-19 complications
Time frame: 30 day
ICU admission
Time frame: 30 day
Mechanical ventilation / O2 requirement
Time frame: 30 day
Relapse or progression of hematologic disease
Time frame: 30 day, 90 day and 180 day
Overall survival
Time frame: 30 day, 90 day and 180 day
Risk factors
Time frame: 30 day, 90 day and 180 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elena Parovichnikova study chair
National Research Center for Hematology
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronavirus Infection and Hematologic Diseases, run by National Research Center for Hematology, Russia at 15 sites in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
30-day all-cause mortality (time frame: 30 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2023.