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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04518735
Recruitment Status : Completed
First Posted : August 19, 2020
Last Update Posted : August 19, 2020
Sponsor:
Information provided by (Responsible Party):
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

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

Study Design
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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 : April 1, 2020
Actual Primary Completion Date : June 30, 2020
Actual Study Completion Date : June 30, 2020

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Groups and Cohorts
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Group/Cohort 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
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Primary Outcome Measures :
  1. Mortality [ Time Frame: From hospital admission to day 28 ]
  2. Transfer to the Intensive Care Unit (ICU) [ Time Frame: From hospital admission to day 28 ]

Secondary Outcome Measures :
  1. Thromboembolic complications [ Time Frame: From hospital admission to day 28 ]
    Venous thromboembolism, ischemic stroke, myocardial infarction or periferal arterial thrombosis during hospitalization for Covid19

  2. Major bleeding complications [ Time Frame: From hospital admission to day 28 ]
    Any bleeding complication grade 3 or 5 according BARC classification


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients of any age and sex, suffering from Covid19 needing hospital admission more than 1 day for treatment and/or supportive care
Criteria

Inclusion Criteria:

  • Patient admitted for COVID-19 at the Hospital de la Santa Creu i Sant Pau,
  • Positive COVID-19 polymerase chain reaction test
  • Length of stay more than 24 hours

Exclusion Criteria:

  • No objective diagnose for COVID-19
  • Outpatient
  • Lenght of stay less than 24hours
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04518735


Locations
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Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, Catalonia, Spain, 08025
Sponsors and Collaborators
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
More Information
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Responsible Party: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
ClinicalTrials.gov Identifier: NCT04518735    
Other Study ID Numbers: IIBSP-COV-2020-24
First Posted: August 19, 2020    Key Record Dates
Last Update Posted: August 19, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau:
Covid19
Oral anticoagulant
VKA
DOAC
 Antiplatelet therapy
Heparin
Low molecular-weight heparin
Additional relevant MeSH terms:
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COVID-19
Pneumonia, Viral
Pneumonia
Respiratory Tract Infections
Infections
Virus Diseases
Coronavirus Infections
 Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Anticoagulants