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

• Status: Recruiting
• Trial end date: 2021-03-30
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Imperial College London
• Treatments: Aspirin; Atorvastatin; Clopidogrel; Omeprazole; Rivaroxaban

Criteria

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 cardiac pathology needing ACS treatment.

2. Myocarditis with serum Troponin > 5000

3. Bleeding risk suspected e.g. recent surgery, history of GI bleed, other abnormal blood results (Hb<10g/dl, Plts <100, any evidence of DIC)

4. Study treatment may negatively impact standard best care (physician discretion).

5. Unrelated co-morbidity with life expectancy <3 months.

6. Pregnancy.

7. Age <18 years and >85 years.