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24th April 2023
Treatment with fluvoxamine (FA) in high-risk COVID-19 patients reduces the need for hospitalisation. This action likely arises because of an anti-inflammatory and anti-viral effect of the drug. In addition, inhaled budesonide improves the time to recovery and possibly hospital admissions or death in patients with COVID-19. As both drugs appear to be effective, whether fluvoxamine and inhaled budesonide together might offer additional benefit is unclear.
In the current trial, researchers randomised high-risk, ambulatory patients 1:1 to oral FA plus inhaled budesonide or matching placebos. Fluvoxamine 100 mg twice daily and budesonide 800 mcg twice daily were given for 10 days. The primary outcome was a composite of emergency setting retention for COVID-19 for more than 6 hours, hospitalisation, and or suspected complications due to progression of COVID-19 within 28 days of randomisation.
Fluvoxamine and Inhaled budesonide and COVID-19 outcomes
The study had 1476 participants with 738 given FA and inhaled budesonide. Symptoms were present for a median of three days before randomisation. The median age was 51 years with women accounting for 60.8% of the total. Overall, 42% of participants had received 3 doses of a COVID-19 vaccine.
The proportion of patients in an emergency setting for more than 6 hours or hospitalised due to COVID-19 was lower in the treatment group than the placebo group (relative risk, RR = 0.50, 95% CI 0.25 – 0.92). These results gave a number needed to treat of 53.
The findings suggest that oral fluvoxamine plus inhaled budesonide in high-risk outpatients with early COVID-19 reduces the incidence of severe disease requiring advanced care.
Reis G et al. Oral Fluvoxamine With Inhaled Budesonide for Treatment of Early-Onset COVID-19 : A Randomized Platform Trial. Ann Intern Med 2023
2nd November 2021
Giving fluvoxamine to patients with one or more risk factors for severe illness in COVID-19, reduced the proportion of patients requiring more than 6 hours of emergency care when administered within 7 days of symptom onset. This was the conclusion of a study from researchers based at the Department of Medicine, Pontifícia Universidade Católica de Minas Gerais, Belo Horizonte, Brazil. Although vaccination against COVID-19 has become a priority across the globe, some work is continuing on the repurposing of existing medicines to treat the virus. One such drug is the antidepressant fluvoxamine which is an agonist for the sigma-1 receptor which is a chaperone protein at the endoplasmic reticulum with anti-inflammatory properties. In addition, a previous small trial in 152 patients with COVID-19, found that those given fluvoxamine had a lower likelihood of clinical deterioration over 15 days.
For the present study, researchers wanted to provide more robust evidence for the value of fluvoxamine in COVID-19. They performed a randomised, placebo-controlled trial among individuals who presented at an outpatient care setting with acute symptoms consistent with COVID-19 infection. All included patients had at least one additional risk factor for more severe illness e.g., diabetes, hypertension, symptomatic asthma etc., and a positive rapid antigen test for COVID-19. Individuals were then randomised 1:1 to receive fluvoxamine 100 mg twice daily for 10 days or matching placebo within 7 days of the onset of COVID-19 symptoms. The primary outcome was a composite endpoint of medical admission to a hospital setting due to COVID-19-related illness but who remained longer than 6 hours or who were hospitalisation due to progression of their illness within 28 days of randomisation. Several secondary outcomes were measured including hospitalisation for COVID-19, time to hospitalisation, number of days in hospital.
A total of 1497 patients with a mean age of 50 years (58% female) were randomised to either fluvoxamine or placebo. Overall, 180 patients assigned to fluvoxamine and 251 given placebo had any form of interaction with a COVID-19 emergency setting (relative risk, RR = 0.73, 95% CI 0.62 – 0.88). In the treatment group, 11% of participants compared with 16% in the placebo arm had the primary outcome event, of which 87% were hospitalisations, (RR = 0.69, 95% CI 0.53 – 0.90), giving a number needed to treat of 20 (i.e., 1/0.05).
There were no significant differences for any of the secondary outcomes, e.g., for hospitalisations ,the rates were 10% vs 13% (fluvoxamine vs placebo, p = 0.10). In addition, there 17 deaths in the treatment arm and 25 in the placebo group which was also non-significant.
The authors commented on how use of fluvoxamine for 10 days, was associated with a clinically important absolute risk reduction of the primary outcome. Furthermore, a limitation was the the study was undertaken before the more widespread availability of COVID-19 vaccines hence it remains unclear as to the effectiveness of fluvoxamine in those who have been vaccinated.
Reis G et al. Effect of early treatment with fluvoxamine on risk of emergency care and hospitalisation among patients with COVID-19: the TOGETHER randomised, platform clinical trial. Lancet Glob Health 2021