Clinical trial NCT04333407: Preventing Cardiac Complication of COVID-19 Disease With Early Acute Coronary Syndrome Therapy: A Randomised Controlled Trial.
Official title: Preventing Cardiac Complication of COVID-19 Disease With Early Acute Coronary Syndrome Therapy: A Randomised Controlled Trial.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: COVID-19
Keywords: Coronavirus, SARS-CoV-2, COVID-19, Cardiovascular
Lead sponsor: Imperial College London
Sponsor class: OTHER
First posted: 2020-04-03
Enrollment: 320
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective Multicentre Randomised Controlled Trial
Primary purpose: TREATMENT

Brief 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.


Eligibility 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 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

Primary outcomes:
measure: All-cause mortality
timeFrame: 30 days
Secondary outcomes:
measure: An ordinal outcome measure of 4 levels (1 - Death, 2 - Intensive Care Unit environment, 3 - In Hospital, 4 - At Home).
timeFrame: 30 days
measure: Peak troponin
timeFrame: 7- and 30- days
measure: Time to discharge
timeFrame: Up to 30 days
measure: Need for non-invasive ventilatory support
timeFrame: 30 days
measure: Need for invasive ventilatory support
timeFrame: 30 days.
measure: Need for mechanical circulatory support
timeFrame: 30 days
measure: Need for renal replacement therapy
timeFrame: 30 days
measure: Bleeding Academic Research Consortium (BARC) bleed event
timeFrame: 30 days
measure: Cessation of randomized active arm therapy
timeFrame: 30 days
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Charing Cross Hospital
Study officials:
affiliation: Imperial College Healthcare NHS Trust
name: Prapa Kanagaratnam, FRCP, PhD
role: PRINCIPAL_INVESTIGATOR
References: