Cheap SSRI drug proves successful in reducing Covid-related hospitalization times in large trial
Another weapon against Covid-19 could be made more prominent as results from a large, placebo-controlled trial published in the Lancet on Wednesday evening provide compelling evidence that the cheap SSRI fluvoxamine may reduce Covid-related hospitalization times.
Of the 741 participants who received fluvoxamine in the trial in Brazil, 79, or 10.6%, required an extended stay for more than six hours in an emergency setting or hospitalization, compared to 119 out of the 756 (15.7%) participants who received placebo.
The cheap and readily available selective serotonin reuptake inhibitor, typically used to treat depression or OCD, could quickly join the ranks of other outpatient treatments like monoclonal antibodies, or Merck’s hotly anticipated antiviral molnupiravir.
The authors from Brazilian universities and McMaster University in Ontario wrote:
Our trial has found that fluvoxamine, an inexpensive existing drug, reduces the need for advanced disease care in this high-risk population. A 10-day course of fluvoxamine costs approximately US$4 even in well resourced settings. Our study compares favourably with the treatment effects of more expensive treatments including monoclonal antibodies for outpatient treatment. The absolute number of serious adverse events associated with fluvoxamine was lower than for placebo and this might reflect the modulatory effect of fluvoxamine on systemic inflammation in these participants.
David Boulware of the University of Minnesota Medical School, who was unaffiliated with the trial, told Endpoints News via email of the results, “the outcomes were better among those who could tolerate the medicine, where the most common side effects were gastrointestinal in nature. Among those who took at least 80% of the fluvoxamine, there was a two-thirds reduction in hospitalizations or ER visits – as well as deaths being reduced by 90% with only one death in the fluvoxamine [arm of the trial] versus 12 with placebo.”
The trial was designed and done in partnership with local public health authorities from 11 cities in Brazil to simultaneously test potential treatments for early disease via a master protocol. Master protocols have long been favorites of top FDA and NIH leaders like Janet Woodcock and Francis Collins.
Previously, a trial in the US of a higher dose of fluvoxamine (100 mg three times a day for 15 days) included a lower risk group for the primary outcome but found no cases among 80 patients receiving fluvoxamine versus six cases among 72 patients receiving placebo, according to the Lancet paper. A large observational study from France also showed a reduction in the use of intubation or death with the use of SSRIs among 7,230 hospitalized Covid-19 patients.
There are still two US trials investigating a lower fluvoxamine dose of 50 mg twice daily which would have fewer side effects and be more tolerable, according to Boulware.
Walid Gellad, director of the University of Pittsburgh’s Center for Pharmaceutical Policy & Prescribing and also unaffiliated with the trial, told Endpoints that this is “a really important trial showing again the power of these adaptive platform trials. The big questions were stated at the end of the editorial: what does this mean for vaccinated people, and how does this fit in terms of other therapies we now have, like monoclonal antibodies and molnupiravir. The drug again highlights the importance of early and quick diagnosis, which is required to get people medications as early as possible.”