Remdesivir has not yet been approved by the FDA as a treatment for COVID-19
Columbus, Ohio – The Ohio Department of Health (ODH), and the Ohio Hospital Association (OHA), will work together to distribute remdesivir across Ohio that was received from the federal government on Tuesday, May 12.
Ohio’s allocation is not enough to treat all patients.
The Food and Drug Administration (FDA), has issued an Emergency Use Authorization for remdesivir to allow it to be administered to patients. It is currently being studied in the treatment of COVID-19 in clinical trials and has been found to shorten the duration of disease from 15 to 11 days in patients being treated in-patient hospital settings.
Ohio has received an allotment of 20 cases of remdesivir which is estimated for about 100 patients. How to distribute the drug was decided by the clinical leaders of the geographic zones that were created to help Ohio with this pandemic response. The decision-makers within each zone consisted of clinicians, pharmacists, public health officials, policymakers, ethicists, and other health disciplines that helped with the allocation amount to specific hospitals. The decision was based on the percentage of mechanically ventilated patients; which deems them to have the highest severity level.
“This is not a cure, but early signs indicate that it can help in the treatment of COVID-19,” said ODH Director Amy Acton, M.D., MPH. “Ohio’s allocation is not enough to treat all patients, so we are working with medical experts to ensure distribution is based on clinical best practices.”
“Ohio hospitals are committed to providing care and services to ensure the health and safety of our communities,” said Mike Abrams, President, and CEO, Ohio Hospital Association. “We appreciate the efforts of our policymakers and state leaders to secure resources and treatment to help in the delivery of care for patients impacted by COVID-19.”
Individual hospitals will be responsible for using clinical justification on the distribution of the medication to specific patients.
Remdesivir is administered intravenously and in two courses depending on the severity of the disease. Patients will receive either a 5-day (6-dose) course or a 10-day (11-dose) course, as clinically indicated.
Individual hospitals will be responsible for using clinical justification on the distribution of the medication to specific patients. Whenever the number of patients in need of remdesivir exceeds the supply of the medication, hospitals will use internal processes appropriate for the allocation of scarce resources.
Remdesivir is an investigational medication. While clinical trials indicate that the use of remdesivir has shortened the recovery time for some coronavirus patients, it has not yet been approved by the FDA as a treatment for COVID-19. The EUA and use of remdesivir for the treatment of COVID-19 is only due to the nature of the pandemic, the impact it has had on the population, and the fact that there is no adequate, approved, and available alternative to the emergency use of remdesivir for the treatment of COVID-19.