COVID-19 News: Thai Study Shows That Fluvoxamine Does Not Prevent Deterioration In Mild To Moderate COVID-19!
Nikhil Prasad Fact checked by:Thailand Medical News Team Oct 07, 2023 1 year, 1 month, 4 weeks, 2 days, 22 hours, 8 minutes ago
COVID-19 News: The COVID-19 pandemic has been a global health crisis of unparalleled proportions, leading to immense mortality and morbidity. Initially, the pandemic brought with it a case fatality rate (CFR) of 2.3%. However, as of 2023, this rate has decreased substantially to a range of 0.05%–0.5%, owing to various factors such as vaccination efforts and increased understanding of the disease. Nevertheless, the post-pandemic era is still marked by challenges, including waning immunity, vaccination hesitancy, the persistence of comorbidities, and the absence of new therapeutic agents.
In the battle against COVID-19, researchers have explored various treatment options, including antiviral drugs, monoclonal antibodies, and repurposed medications like fluvoxamine. While some drugs have shown promise, their effectiveness remains a subject of debate, with fluvoxamine being a prime example. Some Western ‘experts’ and Western
COVID-19 News media extolled about the benefits of using fluvoxamine while there were warnings that it could also exacerbate heart issues already being created by the SARS-CoV-2 virus! (Refer to the links at the end of the article about the dangers of using fluvoxamine to treat COVID-19)
Fluvoxamine, a non-sedating antidepressant, has garnered attention due to its potential as a treatment for COVID-19. It is a selective serotonin reuptake inhibitor (SSRI) and a σ-1 receptor (S1R) agonist, which is believed to have anti-inflammatory and antiviral properties. This dual mechanism of action made fluvoxamine an attractive candidate for managing COVID-19, particularly in cases marked by cytokine storms and inflammation.
Early Findings and Controversies
The initial enthusiasm for fluvoxamine was driven by the STOP COVID 1 trial, a double-blind, randomized controlled trial (RCT) that showed a remarkable 0% rate of deterioration to severe COVID-19 in patients receiving fluvoxamine compared to 8.7% in the placebo group. However, subsequent analyses, including the STOP COVID 2 trial, raised questions about its efficacy, with a deterioration rate of 4.8% in the fluvoxamine group and 5.5% in the placebo group. This shift in results emphasized the need for further investigation.
A significant development in the assessment of fluvoxamine's efficacy came from a large-scale Brazilian RCT, which demonstrated a reduction in hospitalization by 11% in the fluvoxamine group compared to 16% in the placebo group, accompanied by a decrease in emergency room visits. These findings fueled hope that fluvoxamine could play a pivotal role in managing COVID-19.
The Thai Perspective: The Fluvoxa Trial
In light of these diverse findings and the urgent need for effective treatments, leading medical researchers from the Division of Infectious Diseases at Chulabhorn Hospital in Thailand ( A prestigious and leading hospital cum research institution) conducted a historical cohort study known as the Fluvoxa Trial. This study aimed to assess the real-world effectiveness of fluvoxamine in preventing deterioration in patients with mild to moderate COVID-19. It is crucial to note that this study took place during the outbreak of the Alpha
and Delta variants, which presented unique challenges.
The Fluvoxa Trial enrolled a total of 752 eligible patients, with 234 receiving fluvoxamine and 518 receiving standard of care (SOC) treatment. The primary objective was to evaluate the effectiveness of fluvoxamine in preventing clinical deterioration by the fifth day of treatment. The results of this study yielded critical insights into the role of fluvoxamine in the management of COVID-19.
Key Worrisome Findings of the Fluvoxa Trial
The Fluvoxa Trial revealed some key findings that have significant implications for the use of fluvoxamine in the treatment of mild to moderate COVID-19:
-Effectiveness in Preventing Deterioration: Contrary to early hopes, fluvoxamine treatment was found to be ineffective in preventing clinical deterioration by the fifth day of treatment. Approximately 86.1% of patients in the fluvoxamine group did not experience clinical deterioration, compared to 78.7% in the SOC group.
-Pneumonia Incidence: One of the most concerning findings was the higher incidence of pneumonia in the fluvoxamine-treated group. This observation raised concerns about the potential for fluvoxamine to exacerbate respiratory complications.
-Hospitalization Rates: Patients receiving fluvoxamine were more likely to require hospitalization compared to those in the SOC group. This suggests that the medication may not be suitable for outpatient treatment.
-Oxygen Supplementation: Another concerning outcome was the increased need for oxygen supplementation in the fluvoxamine group. This could have implications for healthcare resources and patient well-being.
-Viral Shedding: The study also noted that the fluvoxamine group exhibited less reduction in viral shedding compared to the SOC group. This suggests that the medication may not exert significant antiviral effects in the early stages of the disease.
-Mechanical Ventilation and Survival: Despite the differences in clinical deterioration, there was no significant variance in the need for mechanical ventilation, intensive care unit (ICU) admission, or overall survival between the two groups.
Discussion and Implications
The findings of the Fluvoxa Trial raise important questions about the role of fluvoxamine in the management of mild to moderate COVID-19. While early studies suggested promise, this real-world cohort study paints a more complex picture. Several factors may contribute to these disparate outcomes.
Firstly, the timing of fluvoxamine administration may play a critical role. The Fluvoxa Trial specifically enrolled patients in the early stages of the disease, when the virus is actively replicating. This phase may not be the ideal window for fluvoxamine to exert its antiviral effects.
Secondly, the study population itself presented unique characteristics. A substantial proportion of participants in the trial had comorbidities, and a majority presented with pneumonia. Additionally, a significant portion of patients received corticosteroid treatment, which exceeded the standard of care (SOC). These factors could have influenced the overall outcomes of the study.
Thirdly, the dosage of fluvoxamine administered in the Fluvoxa Trial was lower than that used in recent studies reporting positive outcomes. This dosage discrepancy may have contributed to the differing results.
Moreover, the Fluvoxa Trial was conducted during the Alpha and Delta variant surge periods, which raises questions about the direct applicability of its findings to the ongoing Omicron wave.
It is important to acknowledge that systematic reviews and previous real-world cohort studies have suggested that fluvoxamine can reduce hospitalization rates, decrease mortality, and lead to the absence of residual symptoms. These results contrast with the Fluvoxa Trial's findings.
Conclusion
In conclusion, the Fluvoxa Trial provides valuable insights into the use of fluvoxamine in the management of mild to moderate COVID-19. While the study did not demonstrate the expected effectiveness in preventing deterioration by day 5, it did show some improvement in WHO clinical progression scores by day 14, accompanied by a favorable safety profile.
However, the concerning higher incidence of pneumonia, increased hospitalization rates, and elevated oxygen supplementation requirements in the fluvoxamine-treated group warrant careful consideration. The study also suggests that fluvoxamine may not significantly impact viral shedding in the early stages of the disease.
The role of fluvoxamine in COVID-19 treatment remains an area of ongoing debate, and its effectiveness may be influenced by various factors, including timing, dosage, and patient characteristics. As the world continues to grapple with the evolving COVID-19 landscape, further research and clinical trials are essential to determine the precise role of fluvoxamine and other potential treatments in combating this global health crisis.
The study findings were published in the peer reviewed Journal of Infection and Public health.
https://www.sciencedirect.com/science/article/pii/S1876034123003374
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