Covid19CORE-THROMBNCT04780295
Coronavirus Disease (COvid-)19 REgistry on THROMBOSIS Complications
An observational study of Covid19, run by Johannes Gutenberg University Mainz at 30 sites in 8 countries.
Trial summary
This online-based, observational retrospective registry aims to (i) study the rate of cardiovascular events, encompassing venous thromboembolic and arterial events, in consecutive hospitalized patients with coronavirus (Covid19), (ii) investigate the prevalent use of thromboprophylaxis, (iii) describe the use of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19
- How many people
- 2,708 participants
- Where
- 30 sitesin 8 countries
- Study dates
- 15 Apr 2020to 18 May 2021
- 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: Given the observational nature of this registry, no exclusion criteria will be applied.
Who may be able to join
- Hospitalized patients aged ≥ 18 years with a positive test for severe acute respiratory syndrome corona virus 2 (SARS-CoV2)
Who cannot join
- None
Trial locations and contacts
30 sites in 8 countries.
30 sites in 8 countries
Italy13 sites
University of Bologna
Bologna, 40126
Azienda Socio Sanitaria Territoriale (ASST) Lariana
Como, 22100
Ospedale Sacra Famiglia Fatebenefratelli
Erba, 22036
Presidio Ospedaliero Santa Croce di Fano
Fano, 61032
IRCCS Ospedale Policlinico San Martino
Genova, 16132
Ospedale Civile di Guastalla - Azienda Unità Sanitaria Locale (AUSL) Reggio Emilia
Guastalla, 42016
Azienda Ospedaliera di Padova
Padova, 35128
Ospedale Maggiore di Parma - Azienda Ospedaliero Universitaria di Parma
Parma, 43126
Fondazione IRCCS Policlinico San Matteo
Pavia, 27100
Ospedale Civile di Castel San Giovanni - Azienda Unità Sanitaria Locale (AUSL) di Piacenza
Piacenza, 29015
Santa Maria Nuova Hospital - Azienda Unità Sanitaria Locale (AUSL) IRCCS di Reggio Emilia
Reggio Emilia, 42123
IRCCS Humanitas Clinical and Research Hospital
Rozzano, 20089
Università degli studi dell' Insubria (University of Insubria)
Varese, 21100
Germany9 sites
Universitätsklinikum Koeln
Cologne, 50937
Augusta-Krankenhaus Duesseldorf
Düsseldorf, 40472
Universitäts-Herzzentrum Freiburg
Freiburg im Breisgau, 79106
Universitätsklinikum des Saarlandes und Medizinische Fakultät der Universität des Saarlandes
Homburg, 66421
DRK Kliniken Berlin Köpenick
Köpenick, 12559
Universitätsmedizin Mainz
Mainz, 55131
Krankenhaus Neuwittelsbach
Munich, 80639
Paracelsus Medizinische Privatuniversität am Klinikum Nuernberg
Nuremberg, 90419
DRK Kliniken Berlin Westend
Westend, 14050
Brazil3 sites
Unicamp (Universidade Estadual de Campinas; University of Campinas)
Campinas, 13083-970
Hospital Sírio-Libanês
São Paulo, 01308-050
Hospital de Campanha Anhembi
São Paulo, 02012-021
Mexico1 site
Instituto Nacional de Cardiologia Ignacio Chavez (National Institute of Cardiology Igancio Chavez)
Mexico City, 14080
About this study
Official title: COvid-19 REgistry on THROMBOSIS Complications Associated With Hospitalization
This online-based, observational retrospective registry aims to (i) study the rate of cardiovascular events, encompassing venous thromboembolic and arterial events, in consecutive hospitalized patients with coronavirus (Covid19), (ii) investigate the prevalent use of thromboprophylaxis, (iii) describe the use of imaging tests for the detection of cardiovascular events in patients with Covid19. This will also facilitate and constitute the basis for the conduction of interventional thromboprophylaxis studies in patients with Covid19.
- Conditions
- Covid19
- Keywords
- Covid19, thromboembolism, thromboprophylaxis, pulmonary embolism, anticoagulation
- Medical subject headings
- COVID-19, Thromboembolism, Pulmonary Embolism
What is being measured
The primary outcome is the main question the study is designed to answer.
Fatal or non-fatal venous thromboembolism (VTE)
Rate of thromboembolic events encompassing pulmonary embolism (PE) and deep vein thrombosis (DVT)
Measured: during index hospitalization for Covid19
Fatal or non-fatal cardiovascular events
Rate of cardiovascular events encompassing stroke and myocardial infarction
Measured: during index hospitalization for Covid19
All-cause death
Rate of death from any cause
Measured: during index hospitalization for Covid19
Secondary outcomes (5)
Prevalence of cardiovascular risk factors
Baseline prevalence of cardiovascular risk factors and use of specific medications (statins, Angiotensin-converting enzyme [ACE] inhibitors)
Measured: at baseline/enrollment
Length of hospitalization
Duration of inpatient stay
Measured: first index hospitalization for Covid19
Prevalent use of in-hospital thromboprophylaxis
Use of unfractionated heparin (UFH), low-molecular weight heparin (LMWH), or direct oral anticoagulants (DOAC) on/after admission due to Covid19
Measured: during index hospitalization for Covid19
In-hospital course of D-dimer (μg/mL)
Course of laboratory biomarker
Measured: during index hospitalization for Covid19
In-hospital course of Troponin (ng/ml)
Course of laboratory biomarker
Measured: during index hospitalization for Covid19
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2021
- Study start15 Apr 2020
- Primary completion18 May 2021
- Study completion18 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies 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
- Retrospective
- Enrolment
- 2,708 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johannes Gutenberg University Mainz
- Sponsor type
- University, hospital or other
- Collaborators
- University of Zurich
- Responsible party
- Principal investigator, Prof. Stavros Konstantinides, MD, Johannes Gutenberg University Mainz
- Investigators
- Stavros Konstantinides, MD, Prof, Study chair, University Medical Center Mainz, Johannes Gutenberg University Mainz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04780295
- Sponsor's protocol ID
- CTH C010
- Other IDs
- DRKS00022277
- Acronym
- CORE-THROMB
- Status last verified
- Jan 2023
- First submitted
- 9 Feb 2021
- Last updated
- 25 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COvid-19 REgistry on THROMBOSIS Complications Associated With Hospitalization
- ClinicalTrials.gov ID
- NCT04780295
- Acronym / sponsor ID
- CORE-THROMB / CTH C010
- Conditions
- Covid19
- Keywords
- Covid19, thromboembolism, thromboprophylaxis, pulmonary embolism, anticoagulation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,708 participants (actual)
- Lead sponsor
- Johannes Gutenberg University MainzUniversity, hospital or other
- Collaborators
- University of Zurich
- Study start
- 15 Apr 2020 (actual)
- Primary completion
- 18 May 2021 (actual)
- Study completion
- 18 May 2021 (actual)
- First posted
- 3 Mar 2021 (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 online-based, observational retrospective registry aims to (i) study the rate of cardiovascular events, encompassing venous thromboembolic and arterial events, in consecutive hospitalized patients with coronavirus (Covid19), (ii) investigate the prevalent use of thromboprophylaxis, (iii) describe the use of imaging tests for the detection of cardiovascular events in patients with Covid19. This will also facilitate and constitute the basis for the conduction of interventional thromboprophylaxis studies in patients with Covid19.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Given the observational nature of this registry, no exclusion criteria will be applied.
Key inclusion criteria (1 listed)
- Hospitalized patients aged ≥ 18 years with a positive test for severe acute respiratory syndrome corona virus 2 (SARS-CoV2)
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Fatal or non-fatal venous thromboembolism (VTE)
Time frame: during index hospitalization for Covid19
Rate of thromboembolic events encompassing pulmonary embolism (PE) and deep vein thrombosis (DVT)
Fatal or non-fatal cardiovascular events
Time frame: during index hospitalization for Covid19
Rate of cardiovascular events encompassing stroke and myocardial infarction
All-cause death
Time frame: during index hospitalization for Covid19
Rate of death from any cause
5 secondary outcomes
Prevalence of cardiovascular risk factors
Time frame: at baseline/enrollment
Length of hospitalization
Time frame: first index hospitalization for Covid19
Prevalent use of in-hospital thromboprophylaxis
Time frame: during index hospitalization for Covid19
In-hospital course of D-dimer (μg/mL)
Time frame: during index hospitalization for Covid19
In-hospital course of Troponin (ng/ml)
Time frame: during index hospitalization for Covid19
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 25 Jan 2023.
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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.
Stavros Konstantinides, MD, Prof study chair
University Medical Center Mainz, Johannes Gutenberg University Mainz
30 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19, run by Johannes Gutenberg University Mainz at 30 sites in 8 countries.
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 1 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 25 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 30 sites in Italy, Germany, Brazil, Denmark, Ireland and 3 more countries. 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?
Fatal or non-fatal venous thromboembolism (VTE) (time frame: during index hospitalization for Covid19). The study lists 3 primary outcomes in all. 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 25 Jan 2023.