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NCT04780295 Clinical Trial

Coronavirus Disease (COvid-)19 REgistry on THROMBOSIS Complications

Covid19 Clinical Trial

— CORE-THROMB  

Official title:
COvid-19 REgistry on THROMBOSIS Complications Associated With Hospitalization

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04780295
Other study ID # CTH C010
Secondary ID DRKS00022277
Status Completed
Phase
First received
Last updated
Start date April 15, 2020
Est. completion date May 18, 2021

Study information
Verified date January 2023
Source Johannes Gutenberg University Mainz
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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 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.

Recruitment information / eligibility
Status Completed
Enrollment 2708
Est. completion date May 18, 2021
Est. primary completion date May 18, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: Hospitalized patients aged = 18 years with a positive test for severe acute respiratory syndrome corona virus 2 (SARS-CoV2) Exclusion Criteria: None

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Brazil Unicamp (Universidade Estadual de Campinas; University of Campinas) Campinas
Brazil Hospital de Campanha Anhembi São Paulo
Brazil Hospital Sírio-Libanês São Paulo
Denmark Amager and Hvidovre Hospital Hvidovre
Germany DRK Kliniken Berlin Köpenick Berlin Köpenick
Germany DRK Kliniken Berlin Westend Berlin Westend
Germany Universitätsklinikum Koeln Cologne
Germany Augusta-Krankenhaus Duesseldorf Duesseldorf
Germany Universitäts-Herzzentrum Freiburg Freiburg
Germany Universitätsklinikum des Saarlandes und Medizinische Fakultät der Universität des Saarlandes Homburg
Germany Universitätsmedizin Mainz Mainz
Germany Krankenhaus Neuwittelsbach Munich
Germany Paracelsus Medizinische Privatuniversität am Klinikum Nuernberg Nuremberg
Ireland Mater Misericordiae University Hospital Dublin
Italy University of Bologna Bologna
Italy Azienda Socio Sanitaria Territoriale (ASST) Lariana Como
Italy Ospedale Sacra Famiglia Fatebenefratelli Erba
Italy Presidio Ospedaliero Santa Croce di Fano Fano
Italy IRCCS Ospedale Policlinico San Martino Genova
Italy Ospedale Civile di Guastalla - Azienda Unità Sanitaria Locale (AUSL) Reggio Emilia Guastalla
Italy Azienda Ospedaliera di Padova Padova
Italy Ospedale Maggiore di Parma - Azienda Ospedaliero Universitaria di Parma Parma
Italy Fondazione IRCCS Policlinico San Matteo Pavia
Italy Ospedale Civile di Castel San Giovanni - Azienda Unità Sanitaria Locale (AUSL) di Piacenza Piacenza
Italy Santa Maria Nuova Hospital - Azienda Unità Sanitaria Locale (AUSL) IRCCS di Reggio Emilia Reggio Emilia
Italy IRCCS Humanitas Clinical and Research Hospital Rozzano
Italy Università degli studi dell' Insubria (University of Insubria) Varese
Mexico Instituto Nacional de Cardiologia Ignacio Chavez (National Institute of Cardiology Igancio Chavez) Mexico City
Spain Hospital Quirónsalud Málaga
Turkey Erdem Medical Center Istanbul

Sponsors (2)
Lead Sponsor Collaborator
Johannes Gutenberg University Mainz University of Zurich

Countries where clinical trial is conducted

Brazil,  Denmark,  Germany,  Ireland,  Italy,  Mexico,  Spain,  Turkey, 

Outcome
Type Measure Description Time frame Safety issue
Primary Fatal or non-fatal venous thromboembolism (VTE) Rate of thromboembolic events encompassing pulmonary embolism (PE) and deep vein thrombosis (DVT) during index hospitalization for Covid19
Primary Fatal or non-fatal cardiovascular events Rate of cardiovascular events encompassing stroke and myocardial infarction during index hospitalization for Covid19
Primary All-cause death Rate of death from any cause during index hospitalization for Covid19
Secondary Prevalence of cardiovascular risk factors Baseline prevalence of cardiovascular risk factors and use of specific medications (statins, Angiotensin-converting enzyme [ACE] inhibitors) at baseline/enrollment
Secondary Length of hospitalization Duration of inpatient stay first index hospitalization for Covid19
Secondary 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 during index hospitalization for Covid19
Secondary In-hospital course of D-dimer (µg/mL) Course of laboratory biomarker during index hospitalization for Covid19
Secondary In-hospital course of Troponin (ng/ml) Course of laboratory biomarker during index hospitalization for Covid19
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