Preventing Cardiac Complication of COVID-19 Disease With Early Acute Coronary Syndrome Therapy: A Randomised Controlled Trial. (C-19-ACS)

Imperial College London

Status: Terminated

Conditions: COVID-19

Treatments: Drug: Atorvastatin 40mg; Drug: Aspirin 75mg; Drug: Rivaroxaban 2.5 MG; Drug: Clopidogrel 75mg; Drug: Omeprazole 20mg

Study type: Interventional

Funder types: Other

Identifiers

NCT04333407

20HH5868

Details and patient eligibility

About

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.

Enrollment: 320 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Confirmed COVID-19 infection
2. Age =/>40 or diabetes or known coronary disease or hypertension
3. Requires hospital admission for further clinical management.

Exclusion criteria

1. Clear evidence of an acute coronary syndrome or myo-pericarditis that requires specific treatment that precludes randomization.
2. Evidence of active bleeding
3. Pregnancy.
4. Age <18 years

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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320 participants in 2 patient groups

Active Arm

Experimental group

Treatment:

Drug: Rivaroxaban 2.5 MG

Drug: Omeprazole 20mg

Drug: Atorvastatin 40mg

Drug: Clopidogrel 75mg

Drug: Aspirin 75mg

Control Arm

No Intervention group