Thursday, January 26, 2023

Fluvoxamine May Not Improve COVID-19 Outcomes

Fluvoxamine, a drug approved to treat obsessive-compulsive disorder, showed promise in some trials as a potentially inexpensive treatment for COVID-19. Yet a study published this month in JAMA found that the drug may be no more beneficial for patients with mild to moderate symptoms than a placebo.

Matthew McCarthy, M.D., of Weill Cornell Medicine and colleagues reported on the results of the ongoing Accelerating COVID-19 Therapeutic Interventions and Vaccines randomized clinical trial, which is testing several outpatient treatments for mild to moderate COVID-19. The participants were 30 years or older, had confirmed COVID-19 infections for 10 days or less, and were experiencing two or more COVID-19 symptoms for 7 days or less. Symptoms included fatigue, fever, cough, nausea, body aches, sore throat, and loss of sense of taste or smell.

Between August 6, 2021, and May 27, 2022, the participants were randomized to receive 50 mg of fluvoxamine twice daily for 10 days or a placebo. The participants completed assessments on the type and severity of their symptoms, any health care visit, and any other medications they started taking daily through the first 14 days. From days 15 to 28, the participants continued to report until they experienced three consecutive days without symptoms, which the authors defined as sustained recovery.

A total of 1,288 completed the trial, with 674 participants in the fluvoxamine group and 614 in the placebo group. The median age of the participants was 47 years, and 67% reported receiving at least two doses of the COVID-19 vaccine. The authors reported the following results:

  • The median time to sustained recovery was 12 days in the fluvoxamine group and 13 days in the placebo group.
  • 3.9% of the participants in the fluvoxamine group were hospitalized, had an urgent care visit, had an emergency department visit, or died through day 28 of the study compared with 3.8% of the participants in the placebo group.
  • By day seven, 92.3% of the participants in the fluvoxamine group and 93.4% of the participants in the placebo group were not hospitalized and did not report any limitation of activities.
  • Adverse events were uncommon in both groups.

The authors pointed to several potential reasons why their study found no therapeutic benefit to fluvoxamine compared with earlier studies. These reasons included the use of a lower dose of fluvoxamine, the timing of the trials (this trial took place during the Delta an Omicron variant surges, while other trials took place earlier in the pandemic), and differences in vaccination rates among the participants.

“In a way, the repeated study of fluvoxamine over the course of the COVID-19 pandemic brings up another issue—the need for continued study of authorized antivirals as the pandemic changes,” Adarsh Bhimraj, M.D., of Houston Methodist Hospital and Jason Gallagher, Pharm.D., of Temple University wrote in an accompanying commentary. “Drugs shown to be effective earlier in immune-naive populations and against more problematic SARS-CoV-2 variants require further study to define their role in the current landscape of COVID-19.”

For related information, see the Psychiatric News article “Antidepressants May Reduce Severity of COVID-19.”

(Image: iStock/BlackJack3D)

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