AN new randomized clinical trial showed that the use of fluvoxamine –An antidepressant drug– in the treatment of patients with COVID-19 reduced the hospitalization risk prolonged compared to the control group that received a placebo. The findings were published in the journal. The Lancet Global Health,
The study of this compound is included in the TOGETHER Project, which investigates the effectiveness of reused treatments for covid-19. In this job, 741 patients High-risk Brazilians were treated with this drug. According to the authors, it is treated with the largest clinical trial against the disease carried out with fluvoxamine until the date.
The drug was chosen for study as a possible treatment for covid-19 due to its anti-inflammatory properties.
The university team in Canada, USA and Brazil who conducted the study indicate that the results represent an important step in understanding the benefits of fluvoxamine in outpatients with covid-19 diagnosed early and symptomatically. They also reinforce the concept that fast, high-quality tests can be generated during a pandemic.
“Vaccination developments and campaigns have proven to be effective in reducing the number of new symptomatic cases, hospitalizations and deaths from greed,” he says. Edward Mills, researcher of the McMaster University (Ontario, Canada) and lead co-author of the study.
However, Mills says: “Covid-19 continues to pose a risk to people of resource-poor countries and limited access to vaccination. Therefore, it is very important to identify cheap, available and effective therapies against the disease. I think the re-adaptation of existing drugs that are widely usable and safe is of particular interest”, he emphasizes.
Reduction of hospitalizations and deaths
Fluvoxamine is a selective serotonin reuptake inhibitor (SSRI) that is currently used to treat mental illnesses such as depression and the obsessive compulsive disorders. It was chosen for study as a possible treatment for COVID-19 due to its anti-inflammatory properties.
As indicated Angela Reiersen, professor of psychiatry at Washington University in St. Louis and also a co-author of the work, “fluvoxamine is able to reduce the production of inflammatory molecules called cytokines, which can be triggered by SARS-CoV-2 infection”.
TOGETHER is a randomized trial to investigate the efficacy of eight repurposed treatments for COVID-19
TOGETHER is a randomized trial to investigate the effectiveness of eight treatments reused for covid-19 among high-risk adult outpatients. He started in June 2020 with fluvoxamine and in January 2021 he recruited a Brazilian adult cohort who were symptomatic, tested positive, nor were vaccinated and they had at least one additional high-risk criterion.
In the clinical trial, 741 participants received 100 mg fluvoxamine twice daily for 10 days and 756 received a placebo. Patients were observed for 28 days after treatment.
Among those who received fluvoxamine, 79 (10.6%) required an extended stay of more than six hours in hospital or emergency settings, compared with 119 of 756 (15.7%) patients who received placebo. These results demonstrated an absolute risk reduction for long-term hospitalization and emergency care of 5%, with a relative risk reduction of 32%.
There was one death in the study in the fluvoxamine group compared to 12 in the placebo group.
Although mortality was not a primary study endpoint, in a secondary analysis of patients who took at least 80% of the medication doses, there was one death in the fluvoxamine group, compared with 12 in the placebo group.
As observed Gilmar Reis, co-author and principal investigator of the Pontifical Catholic University of Minas Gerais (Brazil), “the results coincide with those of previous smaller trials. Given the security, tolerance, Easy to use, low cost and wide availability of fluvoxamine, these results may have an important influence on national and international guidelines on the clinical treatment of covid-19”.
Limitations of its use
The authors acknowledge some limitations of the study. Although fluvoxamine is widely available, it is not listed in the WHO Essential Drug List. A closely related SSRI, fluoxetine, is on this list, and it is now crucial to establish whether these drugs can be used interchangeably to treat COVID-19, as well as to determine whether combining fluvoxamine with other drugs will have a greater effect.
In addition, researchers note that the use of drugs, including fluvoxamine, to prevent disease progression and hospitalization fundamentally depends on the reliable identification of individuals at greater risk of deterioration in the early stages of SARS-CoV-2 infection.
Otavio Berwanger, from the Academic Research Organization of Hospital Israelita Albert Einstein in São Paulo (Brazil), states in a related comment that “despite the important results of the TOGETHER study, some questions about the efficacy and safety of fluvoxamine remain open in patients with covide – 19 ”.
While the test is promising – especially since this product is cheap and may be widely available – the impact on the most severe cases remains uncertain.
Penny Ward (King’s College)
“The definitive answer about the effects of this drug on individual outcomes, such as mortality and hospitalizations, has not yet been addressed. It remains to be seen whether fluvoxamine has an additive effect to other therapies, such as monoclonal antibodies and budesonide, and what is the ideal therapeutic regimen for fluvoxamine”, he adds. “It remains unclear whether TOGETHER results extend to other outpatient populations with COVID-19.”
For your part, Penny Ward, a professor at King’s College London, told the Science Media Center UK in spite of [el ensayo] is promising – especially since this product is cheap and may be widely available – the impact on the most severe cases remains uncertain. “
Furthermore, it indicates, “although the study was intended to include high-risk patients, the work demographic, which shows an excess of women and patients under 50, suggests that does not necessarily reflect a very high risk population. hospitalization or covid death for which community intervention is most likely to be beneficial”.
The expert states that “in the future, the inclusion of patients with infection in these trials, despite being vaccinated, it would be important; and the protocols must be modified to allow the entry of this important subgroup”.
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