Source: https://www.skirsch.io/the-case-for-adding-fluvoxamine-to-the-nih-guidelines/
Here is a summary of why fluvoxamine should be considered by the committee for shared decision making.
We knew from November 12, 2020 with the publication of the Lenze study in JAMA it was a potential game changer because the effect size on reducing hospitalization was 100% and the the supporting data (multiple observational studies) was all consistent. Just two weeks later, on December 1, 2020, we knew that the study was confirmed in a real-world evidence trial by Dr. David Seftel at the massive COVID outbreak at Golden Gate Fields.
Efficacy
As of today (Feb 3, 2021), all of the data I’m aware of is all positive: we learned from the Seftel study that everyone who takes the drug has their symptoms resolve in a few days if we catch them early enough. But we have anecdotal evidence that fluvoxamine works in other stages of the disease…. I’ve never heard of a case where any person failed to respond and get back to normal no matter how sick they are… high flow oxygen, intubated patients, etc. It just takes longer and may require a larger dose.
An average effect size of 100% prevention of both hospitalization and long term COVID symptoms after two weeks vs. 12.5% (hospitalization rate) and 60% (long-term COVID symptoms rate) respectively for no treatment in the Seftel study. The combined p-value of just the Lenze and Seftel studies is <.0001. While you can argue that you can’t combine the numbers because the Seftel study was only pseudo randomized and open label, if you look at the Seftel study, the treatment cohort was worse than random based on comorbidities (add in the fact that it included 8 crossovers from the treatment group (who were not counted twice). Therefore the p-values and effect sizes are thus conservative estimates rather than optimistic estimates. The Fisher Exact test shows an effect size of 75% or more with 95% confidence.
All of the observational studies (two French, one German, and one US) showed significant protection with strong p-values.
Safety
As far as I know, there is no data anywhere showing fluvoxamine would cause a single additional death (it will not make COVID outcomes worse). It is safe drug with no reported deaths of overdose in the literature, making it far safer than over the counter drugs such as Tylenol which kills hundreds of people per year. We know the short and long-term safety outcomes when used with COVID: there are no issues. Mild nausea was reported by one patient on the 50mg BID dose.
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