The outbreak of a novel coronavirus (SARS-CoV-2) and associated COVID-19 disease in late December 2019 has led to a global pandemic. At the time of writing, there have been 150 000 confirmed cases and 3500 deaths. Apart from the morbidity and mortality directly related to COVID-19 cases, society has had to also cope with complex political and economic repercussions of this disease. At present, and despite pressing need for therapeutic intervention, management of patients with COVID-19 is entirely supportive. Despite the majority of patients experiencing a mild respiratory illness a subgroup, and in particular those with pre-existing cardiovascular disease, will experience severe illness that requires invasive cardiorespiratory support in the intensive care unit. Furthermore, the severity of COVID-19 disease (as well as the likelihood of progressing to severe disease) appears to be in part driven by direct injury to the cardiovascular system. Analysis of data from two recent studies confirms a significantly higher likelihood of acute cardiac injury in patients who have to be admitted to intensive care for the management of COVID-19 disease. The exact type of acute of cardiac injury that COVID-19 patients suffer remains unclear. There is however mounting evidence that heart attack like events are responsible. Tests ordinarily performed to definitely assess for heart attacks will not be possible in very sick COVID-19 patients. Randomising patients to cardioprotective medicines will help us understand the role of the cardiovascular system in COVID-19 disease. It will also help us determine if there is more we can do to treat these patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
320
• If patient not on aspirin, add aspirin 75mg once daily unless contraindicated.
• If patient not on clopidogrel or equivalent, add clopidogrel 75mg once daily unless contraindicated
* If patient not on an anticoagulation, add rivaroxaban 2.5mg bd unless contraindicated * If patient on DOAC then change to rivaroxaban 2.5mg unless contraindicated
• If patient not on a statin, add atorvastatin 40mg once daily unless contraindicated
• If patient not on a proton pump inhibitor, add omeprazole 20mg once daily.
Charing Cross Hospital
London, United Kingdom
All-cause mortality
All-cause mortality
Time frame: 30 days
An ordinal outcome measure of 4 levels (1 - Death, 2 - Intensive Care Unit environment, 3 - In Hospital, 4 - At Home).
\- In Hospital, 4 - At Home), using a Bayesian longitudinal ordinal model over 30 days
Time frame: 30 days
Peak troponin
Peak troponin within 7- and 30-days post randomization, if available.
Time frame: 7- and 30- days
Time to discharge
Time to hospital discharge (length of stay)
Time frame: Up to 30 days
Need for non-invasive ventilatory support
Need for non-invasive ventilatory support, if data available.
Time frame: 30 days
Need for invasive ventilatory support
Need for invasive ventilatory support, if data available.
Time frame: 30 days.
Need for mechanical circulatory support
Need for mechanical circulatory support, if data available.
Time frame: 30 days
Need for renal replacement therapy
Need for renal replacement therapy, if data available.
Time frame: 30 days
Bleeding Academic Research Consortium (BARC) bleed event
Bleeding Academic Research Consortium (BARC) bleed event, adjudicated
Time frame: 30 days
Cessation of randomized active arm therapy
Cessation of randomized active arm therapy
Time frame: 30 days
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