BackFluvoxamine helps in reducing extended hospitalization: study
The clinical trial is said to be the largest randomised trial to date to assess the effectiveness of fluvoxamine for patients with covid-19 and was done in Brazilian adults
PremiumNEW DELHI : Treating high-risk covid-19 patients with fluvoxamine at an early stage reduced the possibility of prolonged hospitalization, compared to those who received a placebo, showed a study published in The Lancet Global Health on Wednesday.
Fluvoxamine, which is used to treat mental health conditions, such as depression and obsessive-compulsive disorders, was chosen for the clinical trial as a potential treatment for covid-19 due to its anti-inflammatory properties.
“Fluvoxamine may reduce the production of inflammatory molecules called cytokines, that can be triggered by SARS-CoV-2 infection," said Dr Angela Reiersen, associate professor, psychiatry, Washington University, St. Louis, and a co-author of the study.
The TOGETHER trial is said to be the largest randomised clinical trial to date to assess the effectiveness of fluvoxamine for patients with covid-19. Subjects of the study included adults from Brazil.
“Vaccine development and campaigns have proved to be effective and important in reducing the number of new symptomatic cases, hospitalisations, and deaths due to covid-19. However, covid-19 still poses a risk to individuals in countries with low resources and limited access to vaccination," said Dr Edward Mills of McMaster University, co-principal investigator of the trial.
“Identifying inexpensive, widely available, and effective therapies against covid-19 is therefore of great importance, and repurposing existing medications that are widely available and have well-understood safety profiles is of particular interest," he added.
The TOGETHER trial is a randomised adaptive platform trial to investigate the efficacy of eight re-purposed treatments for covid among high-risk adult patients. The trial began in June 2020. The fluvoxamine trial began in January 2021 on a cohort of Brazilian adults who were symptomatic, had tested positive for covid-19, were unvaccinated, and had at least one additional criterion for high risk.
While 741 participants were administered 100mg of fluvoxamine twice daily for 10 days, 756 subjects received a placebo. The trial participants were observed for 28 days after the treatment began. At most, patients who were treated with fluvoxamine spent around six hours to receive treatment at a specialised covid emergency setting, or hospital.
Of the 741 participants who were administered fluvoxamine, 79 required over six hours of treatment in an emergency setting or hospital, compared to 119 who received a placebo. The results demonstrated an absolute reduction in the risk of prolonged hospitalisation or emergency care of 5% and a relative risk reduction of 32%.
In a secondary “per protocol" analysis of patients, who received at least 80% of treatment with fluvoxamine, one death was reported, compared to 12 in the placebo group.
“Our results are consistent with earlier, small trials. Given fluvoxamine’s safety, tolerability, ease of use, low cost, and widespread availability, the findings may have an important influence on national and international guidelines on the clinical management of covid," Said Dr Gilmar Reis, co-principal investigator, Belo Horizonte.
Although fluvoxamine is widely available, it is not on the WHO essential medicines list. A related drug, fluoxetine, is however, on the WHO list.
According to the authors of the study, it is crucial to establish if the medications can be used interchangeably to treat covid, and whether combining fluvoxamine with other drugs will offer effective treatment of SARS-CoV-2 infection.
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