The real-world effectiveness of fluvoxamine therapy in mild to moderate COVID-19 patients; A historical cohort study (Fluvoxa Trial)

Background: Fluvoxamine (FVX) has been proposed as a potential treatment for severe COVID-19 by the sigma-1 receptor agonist, which can reduce cytokine production. However, the efficacy of FVX remains controversial.Methods: A historical retrospective cohort study was conducted in mild to moderate COVID-19 patients, 2:1 ratio of standard of care (SOC) and FVX treatments to assess the effectiveness of FVX in preventing deterioration by the fifth day of treatment.Results: Of 752 eligible patients, 234 received FVX while 518 received SOC, and there was no significant difference in the effectiveness of FVX and SOC in preventing clinical deterioration. On the fifth day after treatment, 86.1 % of patients in the FVX-treated group did not experience clinical deterioration compared to 78.7 % in the SOC group. Notably, the FVX group had higher rates of pneumonia development and hospitalization, requiring more oxygen supplementation while showing less reduction in viral shedding than the SOC group. However, no difference in mechanical ventilation use, ICU admission, and survival was observed.Conclusion: Fluvoxamine treatment is failed to demonstrate effectiveness in preventing deterioration in mild to moderate COVID-19 and may lead to a higher incidence of pneumonia, hospitalization, and oxygen supplementation, necessitating careful consideration before prescribing the drug for COVID-19.(c) 2023 The Author(s). Published by Elsevier Ltd on behalf of King Saud Bin Abdulaziz University for Health Sciences. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/li-censes/by-nc-nd/4.0/).

Automated summary

In mild to moderate COVID-19 patients, fluvoxamine treatment failed to demonstrate effectiveness in preventing disease deterioration and may lead to a higher incidence of pneumonia, hospitalization, and oxygen supplementation.