While there is limited information about the safety and effectiveness of using the investigational antiviral drug remdesivir to treat people with COVID-19, the U.S. Food and Drug Administration on May 1 issued an emergency use authorization for remdesivir in the treatment of hospitalized adults and children with severe cases of the disease.

The emergency use authorization allows for remdesivir to be distributed in the U.S. and administered intravenously by health care providers, as appropriate, to patients with low blood oxygen levels or needing oxygen therapy or more intensive breathing support such as a mechanical ventilator.

Preliminary data released on April 29 from a clinical trial sponsored by the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health (NIH), suggested that hospitalized patients with advanced COVID-19 and lung involvement who received remdesivir recovered faster than similar patients who received placebo.

Results also suggested a survival benefit. Recovery in this study was defined as being well enough for hospital discharge or returning to normal activity level.

However, a separate smaller study out of China found that, compared with placebo, treatment with remdesivir did not improve clinical status or decrease mortality in adults with COVID-19, most of whom did not require mechanical ventilation.

The study published in The Lancet looked at adults (≥18 years) hospitalized with confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection and who met the following criteria: <12 days of symptoms, oxygen saturation of ≤94% on room air or a ratio of arterial oxygen partial pressure to fractional inspired oxygen of ≤300 mm Hg, and radiologically confirmed pneumonia.

"The study from China was underpowered due to challenges enrolling patients," said ACC.org Editor-in-Chief Kim A. Eagle, MD, MACC, who noted that only 158 patients were randomized to remdesivir, and 79 to placebo.

"This limited the opportunity to demonstrate a treatment benefit. The study supported by the NIH was able to complete its enrollment target (>1,000 patients). This may explain the apparent discrepancy between the two studies."

Salim Hayek, MD, FACC, in an ACC.org Journal Scan, also highlighted the contrast between the Chinese trial and the preliminary NIH-sponsored clinical trial.

"Whether remdesivir would be effective in a patient population with more severe illness cannot be ascertained from this trial," he said.

"Interestingly, remdesivir did not result in significant reductions in SARS-CoV-2 RNA loads or detectability in upper respiratory tract or sputum specimens for reasons that are unclear, and despite showing strong antiviral effects in preclinical models and adequate concentrations in human plasma. ...We eagerly await the details of [the NIH] report to better understand the discrepant findings."

Clinical Topics: Acute Coronary Syndromes, Anticoagulation Management, Arrhythmias and Clinical EP, Cardiac Surgery, Congenital Heart Disease and Pediatric Cardiology, COVID-19 Hub, Diabetes and Cardiometabolic Disease, Dyslipidemia, Geriatric Cardiology, Heart Failure and Cardiomyopathies, Invasive Cardiovascular Angiography and Intervention, Noninvasive Imaging, Pericardial Disease, Prevention, Pulmonary Hypertension and Venous Thromboembolism, Sports and Exercise Cardiology, Stable Ischemic Heart Disease, Valvular Heart Disease, Vascular Medicine, Anticoagulation Management and ACS, Implantable Devices, SCD/Ventricular Arrhythmias, Atrial Fibrillation/Supraventricular Arrhythmias, Cardiac Surgery and Arrhythmias, Cardiac Surgery and CHD and Pediatrics, Cardiac Surgery and Heart Failure, Cardiac Surgery and SIHD, Cardiac Surgery and VHD, Congenital Heart Disease, CHD and Pediatrics and Arrhythmias, CHD and Pediatrics and Imaging, CHD and Pediatrics and Interventions, CHD and Pediatrics and Prevention, Acute Heart Failure, Pulmonary Hypertension, Interventions and ACS, Interventions and Imaging, Interventions and Structural Heart Disease, Interventions and Vascular Medicine, Angiography, Nuclear Imaging, Hypertension, Sleep Apnea, Sports and Exercise and Congenital Heart Disease and Pediatric Cardiology, Sports and Exercise and ECG and Stress Testing, Sports and Exercise and Imaging, Chronic Angina

Keywords: Acute Coronary Syndrome, Anticoagulants, Arrhythmias, Cardiac, Cardiac Surgical Procedures, Metabolic Syndrome, Angina, Stable, Heart Defects, Congenital, Dyslipidemias, Geriatrics, Heart Failure, Angiography, Diagnostic Imaging, Pericarditis, Secondary Prevention, Hypertension, Pulmonary, Sleep Apnea Syndromes, Sports, Angina, Stable, Exercise Test, Heart Valve Diseases, Aneurysm, COVID-19, Coronavirus, Coronavirus Infections

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