Covid19CORONANCT04518735
Evolution of COVID-19 in Anticoagulated or Antiaggregated Patients (CORONA Study)
An observational study of Covid19, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Covid19
- What is being tested?
- Antithrombotic Therapy (anticoagulant and/or antiplatelet) before admission for Covid19
- Type of treatment
- Pill or oral medicine
- How many people
- 1,707 participants
- Where
- 1 siteSpain
- Study dates
- 1 Apr 2020to 30 Jun 2020
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients of any age and sex, suffering from Covid19 needing hospital admission more than 1 day for treatment and/or supportive care
Who may be able to join
- 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
Who cannot join
- No objective diagnose for COVID-19
- Outpatient
- Lenght of stay less than 24hours
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evolution of COVID-19 in Anticoagulated or Antiaggregated Patients
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.
- Conditions
- Covid19
- Being tested
- Antithrombotic Therapy (anticoagulant and/or antiplatelet) before admission for Covid19
- Keywords
- Covid19, Oral anticoagulant, VKA, DOAC, Antiplatelet therapy, Heparin, Low molecular-weight heparin
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antithrombotic Therapy (anticoagulant and/or antiplatelet) before admission for Covid19Other
Review of medical records during hospitalization and until day 28 post-entry to compare the clinical outcomes depending on previous antithrombotic therapy
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Antithrombotic Therapy (anticoagulant and/or antiplatelet) before admission for Covid19 | |
| Patients on previous antiplatelet therapy | Patients receiving chronic antiplatelet therapy (aspirin, clopidogrel, prasugrel, ticagrelor, cangrelor, dipyridamol) for any indication Receives: Other: Antithrombotic Therapy (anticoagulant and/or antiplatelet) before admission for Covid19 | |
| Patients without antithrombotic therapy | Patients receiving nor chronic oral anticoagulation neither chronic antiplatelet therapy Receives: Other: Antithrombotic Therapy (anticoagulant and/or antiplatelet) before admission for Covid19 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Measured: From hospital admission to day 28
Transfer to the Intensive Care Unit (ICU)
Measured: From hospital admission to day 28
Secondary outcomes (2)
Thromboembolic complications
Venous thromboembolism, ischemic stroke, myocardial infarction or periferal arterial thrombosis during hospitalization for Covid19
Measured: From hospital admission to day 28
Major bleeding complications
Any bleeding complication grade 3 or 5 according BARC classification
Measured: From hospital admission to day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2020
- Study start1 Apr 2020
- Primary completion30 Jun 2020
- Study completion30 Jun 2020
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.
- More trials run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 1,707 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04518735
- Sponsor's protocol ID
- IIBSP-COV-2020-24
- Acronym
- CORONA
- Status last verified
- Aug 2020
- First submitted
- 18 Aug 2020
- Last updated
- 19 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evolution of COVID-19 in Anticoagulated or Antiaggregated Patients
- ClinicalTrials.gov ID
- NCT04518735
- Acronym / sponsor ID
- CORONA / IIBSP-COV-2020-24
- Conditions
- Covid19
- Keywords
- Covid19, Oral anticoagulant, VKA, DOAC, Antiplatelet therapy, Heparin, Low molecular-weight heparin
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,707 participants (actual)
- Lead sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauUniversity, hospital or other
- Study start
- 1 Apr 2020 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 19 Aug 2020 (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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patients on previous oral anticoagulant treatment | – | Other: Antithrombotic Therapy (anticoagulant and/or antiplatelet) before admission for Covid19Patients receiving chronic anticoagulation with vitamin K antagonists (VKA, warfarin or acenocumarol) or with DOACs (dabigatran, rivaroxaban, apixaban or edoxaban) for any indication |
| Patients on previous antiplatelet therapy | – | Other: Antithrombotic Therapy (anticoagulant and/or antiplatelet) before admission for Covid19Patients receiving chronic antiplatelet therapy (aspirin, clopidogrel, prasugrel, ticagrelor, cangrelor, dipyridamol) for any indication |
| Patients without antithrombotic therapy | – | Other: Antithrombotic Therapy (anticoagulant and/or antiplatelet) before admission for Covid19Patients receiving nor chronic oral anticoagulation neither chronic antiplatelet therapy |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients of any age and sex, suffering from Covid19 needing hospital admission more than 1 day for treatment and/or supportive care
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- No objective diagnose for COVID-19
- Outpatient
- Lenght of stay less than 24hours
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Antithrombotic Therapy (anticoagulant and/or antiplatelet) before admission for Covid19Review of medical records during hospitalization and until day 28 post-entry to compare the clinical outcomes depending on previous antithrombotic therapy | Other | Patients on previous antiplatelet therapy, Patients on previous oral anticoagulant treatment, Patients without antithrombotic therapy |
Primary outcome
Mortality
Time frame: From hospital admission to day 28
Transfer to the Intensive Care Unit (ICU)
Time frame: From hospital admission to day 28
2 secondary outcomes
Thromboembolic complications
Time frame: From hospital admission to day 28
Major bleeding complications
Time frame: From hospital admission to day 28
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 19 Aug 2020.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
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 3 inclusion and 3 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 19 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. 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?
Mortality (time frame: From hospital admission to day 28). The study lists 2 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 19 Aug 2020.