Does Fluvoxamine Prevent Hospitalization in Patients with COVID-19?
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With this podcast, we recap innovative, practice changing studies in ten minutes or less. And remember, nothing here is medical advice; we just present the evidence and our (sometimes hot) takes.
Does Fluvoxamine Prevent Hospitalization in Patients with COVID-19?
There was some breaking news recently about yet another re-purposed drug for COVID-19. I know, I know…lots of us might be thinking this is another hydroxychloroquine, azithromycin, or even an ivermectin type situation! But the data actually looked pretty robust, so we figured we should take a deeper dive to determine if an old antidepressant called fluvoxamine could actually help treat patients with COVID-19.
Fluvoxamine is a selective serotonin re-uptake inhibitor originally used for obsessive compulsive disorder. It’s also used off label for depression and anxiety disorders as well. We really don’t hear much about it anymore since it’s taken a back seat to newer antidepressants, but its finally getting its time in the lime-light recently! Nobody knows quite how it works, but it was initially studied because it has some anti-inflammatory effects that may tamp down the hyper-active immune response seen in some patients with COVID-19.
Our trial for this week was a randomized, blinded, placebo-controlled trial of about 1500 adult patients in Brazil with acutely symptomatic COVID-19. Patients had to have laboratory documented COVID-19 with symptom onset within 7 days. It’s important to note that the trial only included patients with at least one risk factor for severe COVID-19 such as diabetes or asthma among other things.
The researchers randomized patients who passed screening to either fluvoxamine 100 milligrams twice daily for 10 days or matching placebo. Randomization was stratified by age over or under 50 as well. We should also mention that this trial is only one arm of a much larger adaptive trial designed to continually test different agents against COVID-19.
The primary outcome was a composite endpoint of hospitalization due to COVID-19. The composite outcome has two components, first is actual admission to the hospital, BUT second is remaining under observation in the emergency department for over 6 hours. This was because in Brazil, resources were so strained that many patients who would usually be admitted were not able to because there were no beds. These patients had to stay put in the emergency department until they were able to either go home or a bed opened up in the hospital. We all know emergency departments take forever, so let’s clear this up now. The 6 hour time period in this study did NOT include time waiting to be seen by a provider.
Now believe it or not, this trial was stopped early because it met its pre-specified superiority end-point. Fluvoxamine resulted in an absolute risk reduction of 5% on the primary composite outcome. This means the number needed to treat with fluvoxamine to prevent one hospitalization or long stay in the ED is only 20! When looking at the results only in patients who reported over 80% adherence, the results became even stronger.
There was no significant difference in treatment emergent adverse events between groups either….So let’s sum this up here. We’ve got a cheap old drug that appears to be safe and effective for preventing hospitalization in those with acute COVID-19 who’ve got risk factors for severe disease! This is what we’ve been hoping for all along. But before we get ahead of ourselves, nothing in medicine is ever the silver bullet we want.
The difference in outcomes was mostly driven by the 6-hour emergency visit stay. While this was used as a proxy for hospitalization due to the conditions in Brazil, it’s probably not the best measure in an ideal world. Additionally, the hospitalization rate in this study was quite high relative to other trials. This is worrisome since it could mean that the standard of care was not being met in Brazil. So, we’d have to ask, does fluvoxamine really prevent hospitalizations when the treatment for COVID-19 is already optimized? Or does it only help in a setting where resources are so strained that COVID-19 treatment doesn’t meet the standard of care?
Despite these concerns, it’s some very promising data. This definitely warrants a trial in the US to determine if fluvoxamine in addition to standard care provides benefit in our health system. We still don’t totally know how or why this drug works, but in the pandemic that we find ourselves in, we need every safe weapon we can find against COVID-19.
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