Effect of Anticoagulation Therapy on Clinical Outcomes in COVID-19

PHASE2TerminatedINTERVENTIONAL
Enrollment

111

Participants

Timeline

Start Date

November 30, 2020

Primary Completion Date

July 20, 2021

Study Completion Date

July 20, 2021

Conditions
COVID-19
Interventions
DRUG

Rivaroxaban

Treatment with Rivaroxaban 20 mg (15 mg for subjects with an eGFR ≥30 mL/min/1.73m2 and \<50 mL/min/1.73m2) once daily (OD) for at least 7 days. In case of hospitalization for more than 7 days, the therapeutic treatment with rivaroxaban will be continued for the duration of the hospital stay until discharge. After at least 7 days of therapeutic treatment with rivaroxaban or after hospital discharge, the study dose of rivaroxaban will be adjusted as follows. Patients randomized to the rivaroxaban study arm will reduce daily dosage to 10 mg OD, provided that they were not diagnosed with a condition requiring continued therapeutic anticoagulation. Thromboprophylaxis therapy will be given for 28 days up to day 35 post randomization or even longer. If the patient cannot be discharged from the hospital prior to day 35 post randomization, the thromboprophylaxis phase will also start upon hospital discharge, but is then shorter than 28 days, because the study ends at day 60 post randomization.

OTHER

Standard Of Care (SOC)

Standard of care treatment

Trial Locations (24)

10117

Department of Pneumology and Infectology Charité University Medicine Berlin, Campus Mitte, Berlin

12200

Department of Cardiology Charité University Medicine Berlin, Campus Benjamin Franklin, Berlin

12683

Internal Medicine/Cardiology department Unfallkrankenhaus Berlin, Berlin

13125

Pulmonary Clinic Berlin-Buch (Lungenklinik Berlin-Buch), Berlin

13353

Department of Cardiology Charité University Medicine Berlin, Campus Virchow, Berlin

13509

Internal Medicine, Cardiology and Intensive Care Clinic Vivantes Humboldt Klinikum, Berlin, Berlin

13585

Berlin Vivantes Hospital Spandau Clinic for internal medicine, cardiology and conservative intensive care medicine, Berlin

14163

Internal Medicine Deparment Hospital Waldfriede, Berlin, Berlin

16321

Immanuel Klinikum Bernau Herzzentrum Brandenburg ( Immanuel Clinic Bernau Heart Center Brandenburg), Bernau bei Berlin

16761

Internal Medicine and Cardiology Klinik Henningsdorf. Oberhavel Kliniken, Hennigsdorf

23538

Medical Clinic II, University Clinic Schleswig-Holstein - Campus Lübeck, Lübeck

33604

Clinic for Cardiology and Intensive Care - Klinikum Bielefeld, Bielefeld

42283

Pneumology, Allergology, Sleep-and Respiratory Medicine Clinic Helios Universitätsklinikum Wupperthal, Wuppertal

44625

Medical Clinic I. Marien Hospital, Universitätsklinikum der Ruhr Universität Bochum, Herne, Herne

45147

Westdeutsches Herz- und Gefäßzentrum Essen (West German Heart and Vascular Center Essen), Essen

55131

Center for Cardiology, University Medicine Mainz, Mainz

56073

Katholisches Klinikum Koblenz-Montabaur (Catholic Hospital Koblenz-Montabaur), Koblenz

60590

Clinic for Cardiology, Angiology und Nephrology Universitätsklinikum Frankfurt, Goethe-Universität, Frankfurt am Main

69120

Clinic for Gastroenterology, Infectology and Poisoning Universitäsklinikum Heidelberg, Heidelberg

79106

Kardiologie und Angiologie I Universitätsherzzentrum Freiburg, Freiburg im Breisgau

81377

Medical Clinic and Polyclinic I. L. Ludwigs-Maximilians-University Clinic, Munich, Munich

88048

Friedrichshafen Hospital Clinic for cardiology, angiology, pneumology and internal intensive care medicine, Friedrichshafen

01307

Medical Clinic I. Universitätsklinikum Carl Gustav Carus, Dresden, Dresden

06120

Universitätsklinikum Halle (Saale) (University Hospital Halle (Saale)), Halle

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)

OTHER

collaborator

Bayer

INDUSTRY

lead

Charite University, Berlin, Germany

OTHER