• A number of clinical trials have been completed using fluvoxamine to treat COVID-19 patients. The results of clinical trials so far have not been clear, or have limitations making it difficult to draw definite conclusions.
• Some trials show fluvoxamine to be effective in treating COVID-19, as it reduces the time spent in hospital and decreases the risk of death, while other trials showing no significant difference in health outcomes.
• The current National Institutes of Health (NIH) COVID-19 treatment guidelines report that there is insufficient evidence either for or against the use of fluvoxamine for the treatment of COVID-19.
• More trials using fluvoxamine to treat COVID-19 need to be done so that there is more specific, evidence based information that can be used to decide whether it can be recommended for COVID-19 treatment. These need to be randomized controlled studies that have large sample sizes and are well designed.

Is fluvoxamine an FDA approved Medicine?

• Fluvoxamine (original brand name: Luvox) is an FDA approved medicine used to treat obsessive compulsive disorder.
• Fluvoxamine is not FDA approved to treat COVID-19.

TOGETHER Clinical Trial

In the TOGETHER trial (NCT04727424) fluvoxamine showed positive results and was effective treating COVID-19 by reducing the risk of hospitalization for patients at risk of progressing to severe disease. This was a randomised, blinded, placebo-controlled trial with 741 patients taking fluvoxamine and 756 taking placebo.

The study showed that patients who were treated with fluvoxamine were more stable and their COVID-19 did not deteriorate as much when compared to placebo patients. This was measured by the number of patients being admitted to a higher level of care, either a COVID-19 emergency setting or transferred to a tertiary hospital.

Fluvoxamine results showed risk of being admitted to a higher level care was lower:

• absolute risk reduction of 5·0%
• relative risk reduction of 32%.

Fluvoxamine patients who had early treatment were less likely to get severe COVID-19 symptoms when compared to the placebo patients, so less likely to be hospitalized.

How does fluvoxamine work for COVID-19?

• Fluvoxamine is being used to treat COVID-19 as it has been shown to have an anti-inflammatory effect and also has an effect on immune cells.
• It does this by binding to sigma-1 receptors in immune cells which lowers production of inflammatory cytokines. The overproduction of cytokines is one of the causes of symptoms of COVID-19.

BOTTOM LINE

• Fluvoxamine is currently being studied for treatment of COVID-19
• Current NIH guidelines report that there is insufficient evidence either for or against the use of fluvoxamine for the treatment of COVID-19.
• More clinical trials are needed to gain certainty on fluvoxamine effect on COVID-19
• Fluvoxamine is an FDA approved medicine for treatment of OCD, it is not an approved medicine for treatment of COVID-19.