Many states in the US are struggling to provide adequate healthcare despite the availability of vaccines. This situation highlights the potential benefit of drugs such as molnupiravir which can reduce hospitalizations for COVID-19 patients. Monupiravir is expensive and may not be available worldwide for some time. Continuous trials to test drugs against COVID-19 may still be of significant value.
One of these trials just showed promising results. The hospitalization rate is reduced by a generic antidepressant that's cheap. Although the trial was short-lived due to its limited effect, the results were so clear that it was necessary to stop the trial.
A decent trial
Fluvoxamine is the drug at issue. It is part of a class of drugs called selective serotonin receptor inhibitors. These drugs are used to treat depression. Although there is no evidence that fluvoxamine could be effective against SARS, CoV-2, a small study did prove it to be useful. Project called TOGETHER, which runs a series clinical trials with cheap drugs already approved for their use, was able to acquire the drug.
TOGETHER aims to avoid the same problems that we have seen in smaller trials for similar drugs. It recruits a large population and conducts randomized, placebo-controlled trials. Patients and doctors are blinded to the drugs being administered. Before the trial begins, a set of standard measures are used to measure success.
The trial involved approximately 750 people who had been infected by SARS-CoV-2 and were showing symptoms. The primary outcome was the need to receive emergency hospital treatment. Brazil, the country in which the trial was conducted, has seen a lot of surges in cases that have limited access to hospitals. Therefore, treatment in emergency care facilities was deemed equivalent to hospitalization.
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Primary outcome, needing emergency treatment, showed a significant but not overwhelming difference between the two groups. 11 percent in fluvoxamine and 16 percent in placebo reached that milestone. This means that 20 people could be treated to prevent one person from needing emergency care, which is a relative risk ratio of 0.73. There was one death in the treatment group, and 12 deaths in the placebo group. This is a significant difference.
A few cautions
Due to the positive results, the trial was cut short in order to give the drug to the placebo group. Due to this, many of the secondary outcomes the trial was tracking failed to reach statistical significance. Some examples include viral clearance, hospital stay, and days spent on a ventilator. It's difficult to know if the drug will cause a general improvement, or if certain aspects of the patient’s health may indicate the drug's mechanism.
However, the drug had its downsides. Fluvoxamine was stopped by 84 people after side effects. The placebo had only 64. Side effects can also occur in placebo users. As with all clinical trials, there were some issues that participants experienced after completing the treatment.
It led to a promising result: People who were most consistent with treatment received the best health outcomes. They were also more likely to have side effects.
Although the trial was better than others that were done with pre-existing drugs it leaves many unanswered questions. We can probably expect more trials, thankfully, as the results were so positive.
Given the 1 in 20 figure, the drug is clearly not a miracle cure. Fluvoxamine may play a significant role in society if the results are consistent. It could reduce hospital overcrowding and help to decrease the number of cases. The 10-day treatment costs just $4. Side effects such as mood swings and headaches are not to be overlooked. Public health officials will have to make difficult decisions until we can get more information from additional trials.
The Lancet Global Health 2021. DOI: 10.1016/S2214-109X(21)00448-4 (About DOIs).
