Ever since notice of a novel coronavirus — COVID-19 — emerged in January, scientists around the world have been proposing, considering and testing different treatments and medicines.
Of all these options, one certainly gained some public attention recently.
If you follow the COVID-19 news, you might’ve noticed that the U.S. Food and Drug Administration (FDA) has authorized a drug called remdesivir for emergency use some time ago. For some time, it seemed to be quite a promising drug. So let’s see whether this fuss is really all that well deserved or not.
First off, let’s take a look at what’s been going on with this new medication, shall we?
Remdesivir, initially called GS-5734, was developed by Gilead, (a pharmaceutical company) to treat the Ebola virus. However, several studies later showed its efficacy against related coronaviruses such as SARS and MERS, which led scientists to bring this drug out yet again when COVID-19 rolled around.
Remdesivir belongs to a class of antivirals called “nucleoside analogues” — complicated name, but the way they infect viruses is actually quite interesting. Simply put, they stop viruses like SARS-CoV-2 (which is the virus that causes COVID-19), from being able to make copies of itself.
An overview of how viruses like SARS-CoV-2 can replicate in the body. (Image Source: Lumen Learning)
In order to cause illness in our body and also spread the virus to others, COVID-19 has to be able to spread its genetic information (in the form of RNA) to cells in our body. This is where the benefits of remdesivir can kick in, by simply messing with the virus’ RNA polymerase, allowing the remdesivir molecule to sneak its way into the RNA copies. This alters the RNA so that instead of containing virus information, the RNA is basically just gibberish. And since the virus isn’t copy-pasting itself everywhere, it can’t spread in the body, and voila! A sick person isn’t as sick anymore.
At least, that’s how it theoretically should work. But in the end, if we want to use a treatment on actual patients, we need to make sure it’s both effective and safe. That is why drugs need to go through rigorous testing in the form of clinical trials, before they become available for general use.
Experiments, Studies, and Trials
Since remdesivir seemed to work on viruses related to COVID-19, it quickly became a possibility in the list of contenders. As April 2020 began to roll around, so did laboratory results, which showed that remdesivir effectively controlled the replication of the virus. Some small clinical trials also agreed with remdesivir’s efficacy, with a marked improvement of 68% of patients. On the other hand, however, more solid evidence in the form of a major clinical trial was still lacking. This did not arrive until the end of April and early May.
The first of the two studies (for clarity’s sake, we’ll call it “A”) was published in late April 2020. It compared the recovery time of those who received remdesivir and those who did not, and unfortunately, the results of trial A found that “remdesivir was not associated with statistically significant clinical benefits.” This disappointing news was then followed a few days later with much more promising results from a different trial (which we’ll call “B”), showing that remdesivir reduced the recovery time in COVID-19 patients from 15 to 11 days. The two conflicting results opened up room for discussion: does remdesivir help people with COVID-19 or not?
While trial A most certainly was very rigorously conducted, it should also be important to note that the trial itself had to be cut short due to a lack of participants. In the end, this trial included 237 patients, as opposed to the much larger population of 1063 in trial B. Trial A’s paper does acknowledge this point, stating that “…confirmation in larger studies [is required].”
So What Now?
Overall, while we’ve gained some optimism from trial B’s results, we’ve clearly still got quite a way to go, starting with confirming these results. After all, out of the 2 major clinical trials conducted as of now, only one has found a correlation between using remdesivir and recovering from COVID-19.
On the bright side, the FDA has approved the drug for emergency use, which can be taken as a good sign of remdesivir’s effectiveness. However, it is also important for us not to get too far ahead of ourselves and start jumping to conclusions, like “we can end the pandemic now!” The FDA’s emergency approval does not mean that remdesivir should be taken by everyone. “Emergency use” only means that remdesivir can be used to treat severe cases of COVID-19, which is up to the doctor’s discretion.
In fact, even its emergency status isn’t even guaranteed—for example, hydroxychloroquine, another former COVID-19 treatment, recently had it’s emergency-use status revoked when more testing showed that no improvement in recovery.
What we do know for certain though, is that much, much more information needs to be gathered on remdesivir. In order to be fully FDA-approved, it not only needs to clearly show benefit in treating COVID-19, but we also need to understand and manage the risks of using remdesivir. Not to say that it is entirely untested in humans—the drug does have a “safety track record…for use in human patients”, but testing is likely needed to determine how remdesivir might work in conjunction with other drugs, for example.
And after it manages to pass all these requirements, we’d also have to distribute the drug to everyone sick. Given that there are already concerns about there being enough remdesivir to go around this summer, production and distribution is quickly shaping up to be a gargantuan task.
In the end, a lot of work still remains before we can call remdesivir a viable treatment option. Nevertheless, however the results of a particular clinical trial bring exciting possibilities—possibilities that require more evidence for us to confirm the potential of remdesivir.