Evolution of COVID-19 in Anticoagulated or Antiaggregated Patients (CORONA Study)

Sponsor

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau (Other)

Overall Status

Completed

CT.gov ID

NCT04518735

Collaborator

(none)

1,707

Enrollment

Location

Actual Duration (Months)

577.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

CORONA is a retrospective, observational, one center study to investigate the clinical evolution (in terms of survival and thromboembolic complications) of patients on chronic treatment with anticoagulants or antiplatelet agents who are admitted to the hospital for COVID-19 compared with patients who do not receive anticoagulants or antiplatelet agents.

Condition or Disease	Intervention/Treatment	Phase
Covid19	Other: Antithrombotic Therapy (anticoagulant and/or antiplatelet) before admission for Covid19

Study Design

Study Type:

Observational

Actual Enrollment :

1707 participants

Observational Model:

Case-Control

Time Perspective:

Retrospective

Official Title:

Evolution of COVID-19 in Anticoagulated or Antiaggregated Patients

Actual Study Start Date :

Apr 1, 2020

Actual Primary Completion Date :

Jun 30, 2020

Actual Study Completion Date :

Jun 30, 2020

Arms and Interventions

Arm	Intervention/Treatment
Patients on previous oral anticoagulant treatment Patients receiving chronic anticoagulation with vitamin K antagonists (VKA, warfarin or acenocumarol) or with DOACs (dabigatran, rivaroxaban, apixaban or edoxaban) for any indication	Other: Antithrombotic Therapy (anticoagulant and/or antiplatelet) before admission for Covid19 Review of medical records during hospitalization and until day 28 post-entry to compare the clinical outcomes depending on previous antithrombotic therapy
Patients on previous antiplatelet therapy Patients receiving chronic antiplatelet therapy (aspirin, clopidogrel, prasugrel, ticagrelor, cangrelor, dipyridamol) for any indication	Other: Antithrombotic Therapy (anticoagulant and/or antiplatelet) before admission for Covid19 Review of medical records during hospitalization and until day 28 post-entry to compare the clinical outcomes depending on previous antithrombotic therapy
Patients without antithrombotic therapy Patients receiving nor chronic oral anticoagulation neither chronic antiplatelet therapy	Other: Antithrombotic Therapy (anticoagulant and/or antiplatelet) before admission for Covid19 Review of medical records during hospitalization and until day 28 post-entry to compare the clinical outcomes depending on previous antithrombotic therapy

Arm

Intervention/Treatment

Patients on previous oral anticoagulant treatment

Patients receiving chronic anticoagulation with vitamin K antagonists (VKA, warfarin or acenocumarol) or with DOACs (dabigatran, rivaroxaban, apixaban or edoxaban) for any indication

Other: Antithrombotic Therapy (anticoagulant and/or antiplatelet) before admission for Covid19

Review of medical records during hospitalization and until day 28 post-entry to compare the clinical outcomes depending on previous antithrombotic therapy

Patients on previous antiplatelet therapy

Patients receiving chronic antiplatelet therapy (aspirin, clopidogrel, prasugrel, ticagrelor, cangrelor, dipyridamol) for any indication

Other: Antithrombotic Therapy (anticoagulant and/or antiplatelet) before admission for Covid19

Review of medical records during hospitalization and until day 28 post-entry to compare the clinical outcomes depending on previous antithrombotic therapy

Patients without antithrombotic therapy

Patients receiving nor chronic oral anticoagulation neither chronic antiplatelet therapy

Other: Antithrombotic Therapy (anticoagulant and/or antiplatelet) before admission for Covid19

Review of medical records during hospitalization and until day 28 post-entry to compare the clinical outcomes depending on previous antithrombotic therapy

Outcome Measures

Primary Outcome Measures

Mortality [From hospital admission to day 28]
Transfer to the Intensive Care Unit (ICU) [From hospital admission to day 28]

Secondary Outcome Measures

Thromboembolic complications [From hospital admission to day 28]
Venous thromboembolism, ischemic stroke, myocardial infarction or periferal arterial thrombosis during hospitalization for Covid19
Major bleeding complications [From hospital admission to day 28]
Any bleeding complication grade 3 or 5 according BARC classification