The antidepressant drug fluvoxamine and the gout drug colchicine are not recommended for patients with mild or moderate COVID-19 because there is currently insufficient evidence that they improve important outcomes for patients, and both drugs carry potential harms, say a WHO Guideline Development Group (GDG) panel of international experts in The BMJ today.
No recommendation was made for either drug in patients with severe or critical illness, given limited or no data.
Fluvoxamine and colchicine are commonly used, inexpensive drugs that have received considerable interest as potential COVID-19 treatments during the pandemic.
However, today’s recommendations against their use reflect ongoing uncertainty about how the drugs produce an effect in the body, and evidence of little or no effect on survival and other important measures, such as risk of hospital admission and need for mechanical ventilation. There is also a lack of reliable data on COVID-19 related serious harms associated with these drugs.
The WHO’s advice against the use of fluvoxamine except in clinical trials was informed by data from three randomized controlled trials (RCTs) involving over 2,000 patients, and their strong advice against colchicine was based on data from seven RCTs involving 16,484 patients.
After thoroughly reviewing this evidence, the panel, which includes experts from around the world including four patients who have had COVID-19, concluded that almost all well informed patients would choose not to receive either fluvoxamine or colchicine therapy for COVID-19 based on available evidence.
The panel noted that none of the included studies enrolled children, so the applicability of these recommendations to children is uncertain. However, they did not see a reason why children with COVID-19 would respond any differently to treatment with fluvoxamine or colchicine.
Today’s recommendations are part of a living guideline, developed by the World Health Organization with the methodological support of MAGIC Evidence Ecosystem Foundation, to provide trustworthy guidance on the management of COVID-19 and help doctors make better decisions with their patients.
Living guidelines allow researchers to update previously vetted and peer reviewed evidence summaries as new information becomes available.
Previously, WHO has made a strong recommendation for use of nirmatrelvir and ritonavir, and conditional recommendations for sotrovimab, remdesivir, and molnupiravir for high-risk patients with non-severe COVID-19.
For patients with severe COVID-19, WHO strongly recommends corticosteroids, with the addition of IL-6 receptor blockers or baricitinib, but advises against the use of convalescent plasma, ivermectin, and hydroxychloroquine in patients with COVID-19 regardless of disease severity.
- This press release was provided by The BMJ