Mary Jane Geiger, MD, PhD
VP, TA Lead Cardiovascular, Drug Development Services, Clinical Research Services
Patients with cardiovascular disease are particularly susceptible to respiratory infections.
A link between common infectious illnesses and cardiovascular diseases has been known for some time. Increasing evidence supports that influenza infections can be a trigger for acute myocardial infarction (AMI) and stroke and that influenza vaccination reduces the risk for cardiovascular morbidity and mortality, particularly in individuals aged 65 and older with high medical risk conditions, including cardiovascular disease. Because of this, the American Heart Association (AHA) and American College of Cardiology (ACC) recommend that patients with cardiovascular disease receive influenza vaccination to prevent flu-related respiratory diseases and other complications, including cardiovascular events. For more information on the flu vaccine and how to prevent the flu visit the CDC webpage.
The novel coronavirus disease 2019 (COVID-19) is an infectious respiratory disease caused by a novel coronavirus first detected in China that has now spread internationally. The World Health Organization has declared COVID-19 a pandemic. The virus responsible for the disease is named “SARS-CoV-2” and the disease it causes has been dubbed COVID-19.
This is a rapidly emerging situation. While most individuals infected with the virus are likely to experience mild symptoms and recover without intensive medical intervention, some persons will develop more severe symptoms and require intensive care support. Fatality rates are low (2.3% based on published reports) but this is likely to change as further information becomes available.
What we have learned from initial epidemiological reports of persons with COVID-19 pneumonia in Wuhan, China (Wang D et al, JAMA 2020;323(11):1061-1069) suggests that older persons with underlying chronic medical conditions may be at higher risk of contracting the disease and have a worse prognosis. In the recently published report of 138 hospitalized patients with confirmed COVID-19 infection, the median age was 56 (range 22 to 92) years and 54% were male. More than 46% had one or more comorbidities, with hypertension (31.2%), cardiovascular disease (14.5%), and diabetes (10.1%) being the most common coexisting conditions. Patients that required ICU care were older and more likely to have underlying cardiovascular and cerebrovascular conditions compared with those that did not require ICU support. Acute cardiac injury (7.2%) and arrhythmia (16.7%) were among the more common complications reported, especially in those requiring ICU care. Fatality rates are also higher for individuals with comorbid CV and diabetes conditions.
Based on available clinical information, the ACC issued a COVID-19 Cardiovascular Guidance for the Clinical Care Team to better care for patients, especially those with existing cardiovascular disease that may contract the virus
COVID-19 clinical operations
Keeping your clinical trial on track in an evolving environment.
Adapting operations to changing conditions
ICON has adapted its services to support sponsors during this time; offering remote monitoring where on-site visits were not permitted, providing additional support to get IMP to patients and pre-recording investigator meetings because of travel restrictions.
Treatment and vaccine trials for COVID-19
ICON is proud to be supporting clients and government organisations in the search for a treatment or vaccine for COVID-19. Download our whitepaper on Pandemic respiratory vaccine clinical trials.
RAAS Antagonists and COVID-19
Angiotensin converting enzyme 2 (ACE2) receptors have been shown to be the entry point into human cells for SARS-CoV-2, the virus that causes COVID-19. In preclinical studies, angiotensin converting enzyme (ACE) inhibitors and angiotensin receptor blockers (ARBs) have been shown to upregulate ACE2 expression in the heart leading to speculation of potential increased risk of COVID-19 infection in persons on these medications. The Heart Failure Society of America (HFSA), ACC, and American Heart Association (AHA) have just released a statement addressing this concern and emphasise there are no experimental or clinical data showing a benefit or adverse outcome with use of these drugs or among COVID-19 patients with cardiovascular disease. Combined, these organizations emphasize the continuation of ACE inhibitors/ARBs for patients currently prescribed them for indications in which they have shown benefit in accordance with clinical practice standards. The European Society of Cardiology (ESC) has issued a similar statement on this topic.
Additional COVID-19 resources for those with cardiovascular disease can be found on the American Heart Association website.