COVID-OUT Clinical Trial Results Announced
- Metformin, an inexpensive diabetes medication, proved superior to other existing medications in treating COVID-19 infection.
- Metformin reduced serious outcomes for COVID-19 by 42% and over 50% when treated within 4 days of symptoms.
- Neither ivermectin nor a low dose of fluvoxamine improved COVID outcomes.
- More information on the COVID-OUT and Media Resources pages
Project Topics
Fluvoxamine for COVID
Fluvoxamine is an existing medication that has shown promise for treatment of COVID-19 infection. It is an SSRI (selective serotonin reuptake inhibitor) antidepressant that is commonly prescribed for obsessive-compulsive disorder.
Fluvoxamine’s ability to fight inflammation and block activation of platelets likely reduce the incidence of sepsis and blood clots that are common features of severe COVID-19 infection.
Results from a small randomized, placebo-controlled study of fluvoxamine was reported by researchers from Washington University. In 152 adult outpatients with symptomatic COVID-19, none treated with fluvoxamine had worsening symptoms but 8.3% of the control group got worse.
Additional real-world experience supported the use of fluvoxamine. In an outbreak of COVID-19 at the Golden Gates Field Racetrack, physicians offered fluvoxamine to the 113 individuals testing positive. In total, 65 persons opted for fluvoxamine, and 48 opted for observation alone. None of the patients selecting fluvoxamine were hospitalized and all recovered, while six of those not taking the medication (or 12.5%) were hospitalized, many had lingering symptoms, and one died.
The Together Trial is a randomized, controlled clinical trial conducted in Brazil that recently reported on the use of fluvoxamine for treatment of COVID-19. Of 1497 people with high-risk of serious COVID outcomes, 11% of those who received fluvoxamine required extended emergency room visits or hospitalization compared to 16% of those who received a placebo. For individuals who took most of the fluvoxamine doses, the death rate was reduced 91%.
A meta-analysis of 3 randomized clinical trials with 2196 participants reported that fluvoxamine had a high probability of being associated with reduced hospitalization in outpatients with COVID. Despite these studies, the US FDA declined to approve emergency use of fluvoxamine.
Additional Resources
Fluvoxamine
- Encyla review
- Hashimoto Y, Suzuki T, Hashimoto K. (2022). Mechanisms of action of fluvoxamine for COVID-19: a historical review. Mol Psychiatry. Jan 7 : 1–10. (free full text)
- Facente SN, Reiersen AM, Lenze EJ. (2021). Fluvoxamine for the Early Treatment of SARS-CoV-2 Infection: A Review of Current Evidence. Drugs. 81(18): 2081–2089. (free full text)
- Lee TC, Vigod S,Bortolussi-Courval E. (2022). Fluvoxamine for outpatient management of COVID-19 to prevent hospitalization:
A systematic review and meta-analysis. JAMA Netw Open. 5(4):e226269. (free full text) - Lenze EJ, Mattar C, Zorumski CF, et al. (2021). Fluvoxamine vs Placebo and Clinical Deterioration in Outpatients With Symptomatic COVID-19: A Randomized Clinical Trial. JAMA. 2020 Dec 8;324(22):2292-2300. (free full text)
- Reis G, Silva E, Silva D, et al. (2021). Effect of early treatment with fluvoxamine on risk of emergency care and hospitalisation among patients with COVID-19: The TOGETHER Randomized Platform Clinical Trial. Lancet Oct 27, 2021. (free full text)
- Seftel D, Boulware DR. (2021). Prospective cohort of fluvoxamine for early treatment of coronavirus disease 19. OFID 8(2):1-3. (free full text)
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