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Difficulty in recruiting eligible participants
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active Arm | Experimental |
| |
| Control Arm | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aspirin 75mg | Drug | • If patient not on aspirin, add aspirin 75mg once daily unless contraindicated. |
|
| Measure | Description | Time Frame |
|---|---|---|
| All-cause mortality | All-cause mortality | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 30 days |
| Peak troponin |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Prapa Kanagaratnam, FRCP, PhD | Imperial College Healthcare NHS Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Charing Cross Hospital | London | W6 8RF | United Kingdom |
No individual participant data will be shared with other researchers or organisations. Anonymised data might be shared with other research organisations
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Prospective Multicentre Randomised Controlled Trial
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| Clopidogrel 75mg | Drug | • If patient not on clopidogrel or equivalent, add clopidogrel 75mg once daily unless contraindicated |
|
| Rivaroxaban 2.5 MG | Drug |
|
|
| Atorvastatin 40mg | Drug | • If patient not on a statin, add atorvastatin 40mg once daily unless contraindicated |
|
| Omeprazole 20mg | Drug | • If patient not on a proton pump inhibitor, add omeprazole 20mg once daily. |
|
Peak troponin within 7- and 30-days post randomization, if available.
| 7- and 30- days |
| Time to discharge | Time to hospital discharge (length of stay) | Up to 30 days |
| Need for non-invasive ventilatory support | Need for non-invasive ventilatory support, if data available. | 30 days |
| Need for invasive ventilatory support | Need for invasive ventilatory support, if data available. | 30 days. |
| Need for mechanical circulatory support | Need for mechanical circulatory support, if data available. | 30 days |
| Need for renal replacement therapy | Need for renal replacement therapy, if data available. | 30 days |
| Bleeding Academic Research Consortium (BARC) bleed event | Bleeding Academic Research Consortium (BARC) bleed event, adjudicated | 30 days |
| Cessation of randomized active arm therapy | Cessation of randomized active arm therapy | 30 days |
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D018352 | Coronavirus Infections |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D001241 | Aspirin |
| D000077144 | Clopidogrel |
| D000069552 | Rivaroxaban |
| D000069059 | Atorvastatin |
| D009853 | Omeprazole |
| ID | Term |
|---|---|
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D013988 | Ticlopidine |
| D058924 | Thienopyridines |
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D009025 | Morpholines |
| D010078 | Oxazines |
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006538 | Heptanoic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D001562 | Benzimidazoles |
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