Fluvoxamine and Covid-19

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Fluvoxamine, sold under the brand name Luvox among others, is an antidepressant of the selective serotonin reuptake inhibitor class which is used primarily for the treatment of major depressive disorder and obsessive–compulsive disorder. Wikipedia

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NIH

COVID-19 Treatment Guidelines

Fluvoxamine

Last Updated: April 23, 2021

Fluvoxamine is a selective serotonin reuptake inhibitor (SSRI) that is approved by the Food and Drug Administration (FDA) for the treatment of obsessive-compulsive disorder and is used for other conditions, including depression. Fluvoxamine is not FDA-approved for the treatment of any infection.

Anti-Inflammatory Effect of Fluvoxamine and Rationale for Use in COVID-19

In a murine sepsis model, fluvoxamine was found to bind to the sigma-1 receptor in immune cells, resulting in reduced production of inflammatory cytokines.1 In an in vitro study of human endothelial cells and macrophages, fluvoxamine reduced the expression of inflammatory genes.2 Further studies are needed to establish whether the anti-inflammatory effects of fluvoxamine observed in nonclinical studies also occur in humans beings and are clinically relevant in the setting of COVID-19.

Recommendation

There is insufficient evidence for the COVID-19 Treatment Guidelines Panel to recommend either for or against the use of fluvoxamine for the treatment of COVID-19. Results from adequately powered, well-designed, and well-conducted clinical trials are needed to provide more specific, evidence-based guidance on the role of fluvoxamine for the treatment of COVID-19.

Clinical Trial Data

Placebo-Controlled Randomized Trial in Nonhospitalized Adults With Mild COVID-19

In this contactless, double-blind, placebo-controlled randomized trial, nonhospitalized adults with mild COVID-19 confirmed by SARS-CoV-2 polymerase chain reaction (PCR) assay within 7 days of symptom onset were randomized to receive fluvoxamine up to 100 mg three times daily or matching placebo for 15 days. The primary endpoint was clinical deterioration (defined as having dyspnea or hospitalization for dyspnea or pneumonia and oxygen saturation [SpO2] <92% on room air or requiring supplemental oxygen to attain SpO2 ≥92%) within 15 days of randomization. Participants self-assessed their blood pressure, temperature, oxygen saturation, and COVID-19 symptoms and reported the information by email twice daily.3

Participant Characteristics

  • A total of 152 participants were randomized to receive fluvoxamine (n = 80) or placebo (n = 72).
  • The mean age of the participants was 46 years; 72% were women, 25% were Black, and 56% had obesity.

Results

  • None of 80 participants (0%) who received fluvoxamine and six of 72 participants (8.3%) who received placebo reached the primary endpoint (absolute difference 8.7%; 95% CI, 1.8% to 16.5%; P = 0.009).
  • Five participants in the placebo arm and one in the fluvoxamine arm required hospitalization.
  • Only 76% of the participants completed the study, and 20% of the participants stopped responding to the electronic survey during the study period but were included in the final analysis.

Limitations

  • The study had a small sample size.
  • A limited number of events occurred.
  • Ascertaining clinical deterioration was challenging because all assessments were done remotely.

Interpretation

In this small placebo-controlled trial, none of the participants who received fluvoxamine and six (8.3%) of those who received placebo reached the primary endpoint. However, due to the study’s reliance on participant self-reports and missing data, it is difficult to draw definitive conclusions about the efficacy of fluvoxamine for the treatment of COVID-19.3

For more:

https://www.covid19treatmentguidelines.nih.gov/therapies/immunomodulators/fluvoxamine/

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