Combination therapy with oral fluvoxamine and inhaled budesonide significantly Cuts Severe Disease in COVID-19

Researchers have found in a randomized controlled trial that treatment with oral antidepressant fluvoxamine plus inhaled budesonide among high-risk outpatients with early COVID-19 reduced the incidence of severe disease requiring advanced care. Previous studies evaluated these drugs independently. The combined effect seems to offer benefits over individual use of each drug. The findings are published in Annals of Internal Medicine.

Researchers for the TOGETHER trial, a randomized adaptive platform trial to investigate the efficacy of repurposed treatments, conducted the trial with 738 symptomatic adults with confirmed SARS-CoV-2 infection residing in a highly vaccinated population. All patients had known risk factors for progression to severe disease. The investigators randomly assigned participants to either fluvoxamine (100 mg twice daily for 10 days) plus inhaled budesonide (800 mcg twice daily for 10 days) or matching placebos over 28 days and monitored for hospitalization and/or clinical progression. They found that administration of the drug combination significantly reduced the rate of COVID-19 progression resulting in prolonged observation in an emergency setting or hospitalization.

The study authors note that theirs is among the first to evaluate a drug combination for treatment of ambulatory patients with COVID-19 in a randomized trial. A difference from prior trials is that Their trial was conducted in a population that was approximately 95% vaccinated. Given the safety, tolerability, ease of use, low cost, and widespread availability of these drugs, the researchers suggest that their findings may be useful for clinicians worldwide who are considering treating outpatients.


Gilmar Reis, Eduardo Augusto dos Santos Moreira Silva, Daniela Carla Medeiros Silva, Lehana Thabane, Vitoria Helena de Souza Campos, Thiago Santiago Ferreira,  Castilho Vitor Quirino dos Santos,  Ana Maria Ribeiro Nogueira,  Ana Paula Figueiredo Guimaraes Almeida, Leonardo Cançado Monteiro Savassi,  Adhemar Dias de Figueiredo Neto, Nicole Ezer, Todd C. Lee, Emily Gibson McDonald, Mona Bafadhel, Christopher Butler, Josue Rodrigues Silva, Mark Dybul, and Edward J. Mills,

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