Is Remdesivir the COVID-19 Drug We’ve Been Waiting For?
Lack of knowledge surrounding the 2019 coronavirus disease, or COVID-19, leads to information being shared in the public arena as soon as it is found which can be both confusing and difficult to keep up with.
As COVID-19 continues to spread throughout the world, it seems everyone is wondering when there will be an effective treatment or vaccine. While the development of a vaccine is in progress, clinical trials are also underway trying to find an effective treatment for COVID-19.
At the beginning of May, the Food and Drug Administration (FDA) authorized remdesivir [rem-de-sa-veer], an antiviral medication, to be used to treat patients who test positive for COVID-19. This approval was an emergency use authorization, which means that with the information we have about the drug, the benefits of trying it will likely outweigh the risks during a pandemic.
Recently, early trial results were released for remdesivir and we will break down what you need to know about this new potential treatment below.
Who was treated?
Remdesivir was provided to just over 1000 people who tested positive for COVID-19 and were hospitalized.
How sick patients were varied among those who received remdesivir. Some were able to breathe on their own, but the majority needed extra help with oxygen treatment. A smaller number were very sick and required extra help breathing with a ventilator.
How were patients treated?
Remdesivir was administered by an IV (into the veins) every day for 5 to 10 days. In order to see how well the medication worked, half of the patients received remdesivir, and the other half received a placebo (an inactive, harmless substance).
The goal of the trial was to see if patients who received remdesivir would recover quicker and/or help decrease the number of people dying from COVID-19.
What did we learn from the early trial results reported?
High ethical standards are important for all clinical trials conducted in humans. The remdesivir trial was no exception and had a committee that met to decide if and when the trial should be stopped early if remdesivir caused harm or if the treatment was so effective it should be provided to all patients.
In order to help physicians and other healthcare providers make the best possible decisions amidst a pandemic, trial results for remdesivir were reported early. The following are the key findings:
· Treatment with remdesivir resulted in a quicker recovery by an average of 4 days
· Remdesivir may prevent death in some patients, but more research is required to understand this benefit fully
· Early treatment with remdesivir seems to work better compared to starting after severe illness has already developed (i.e., when a patient is already on a ventilator)
What do the early trial results mean for patients with COVID-19?
Remdesivir has shown to help some patients recover more quickly (especially when on oxygen). However, even with treatment, many patients still, unfortunately, lost their battle with COVID-19.
So, this means that remdesivir cannot be used as the only treatment for patients with COVID-19 at this time.
Full trial results will be released soon, and hopefully provide more insight into the role of remdesivir for the treatment of COVID-19.
How do patients get access to Remdesivir if needed?
Patients who were enrolled in the clinical trial for remdesivir had access at participating hospitals. In addition, the drug manufacturer also has rules in place for compassionate use under certain circumstances.
Now that the remdesivir clinical trial is complete, the U.S. government is coordinating the donating and distribution of remdesivir to each state. After which, State public health departments will be responsible for determining which hospitals and how much remdesivir they will receive.
Why are clinical trials necessary?
Clinical trials are crucial to understanding if medications are safe and effective in humans. There is a very specific and highly regulated process that all drug manufacturers must follow in order to bring medication to the market. This process is done to ensure that medications are safe and effective!
In times of crisis, the Food and Drug Administration can authorize an emergency use authorization as was done for remdesivir due to the COVID-19 pandemic. In the case of the current pandemic, there is no treatment available that we know of, so the thought process is that something is better than nothing.
However, we must research and understand the drugs we intend to use. A great example is the use of the antimalarial and arthritis drug hydroxychloroquine [hi-drox-ee-chloro-quinn]. This agent was also granted an emergency use authorization for COVID-19 at the end of March early on in the pandemic within the U.S.
The emergency use authorization was granted based on very weak evidence. Excitement for a potential COVID-19 treatment led to widespread use. Ultimately, the FDA backtracked its support in April and recommended against the widespread use of hydroxychloroquine (unless in a hospital or clinical trial) due to the risk of abnormal heart rhythm.
Thus, hydroxychloroquine provides a cautionary tale for why clinical trials are so important instead of making treatment decisions based on one person’s observation. All medications have the potential for side effects making it very important that patients are appropriately monitored, and medications can be used safely – and not merely handed out like harmless candy.
So, while remdesivir may not be the perfect drug we have been waiting for, it is a start. More research will be conducted, and as our experience with COVID-19 improves, so too will our management of this deadly virus.