The drug products previously used to treat malaria were authorized for use in adult and adolescent patients who weigh 50kg or more hospitalized with COVID-19, and for whom a clinical trial is not available, or participation is not feasible.
Moreover, the US Food and Drug Administration (FDA) clarified that the treatments must be administered by a healthcare provider, pursuant to a valid prescription of a licensed practitioner.
Prior to the authorization, which dates Saturday, March 28, there was no authorized treatment for use against the novel coronavirus, the pandemic of which has spread across the world, with the global death toll at the time of writing exceeding 30,000, according to the World Health Organization.
The drugs currently are used to prevent or treat malaria infection, as well as to treat rheumatoid arthritis and lupus. During a press briefing earlier this month, US President Donald Trump suggested that the treatment may be effective for use against the disease, driving the demand to increase rapidly.
A few days later, a man in his sixties in Arizona, US, died after consuming a chemical solvent used in fish tanks that contained the substance, believing that it would help him avoid getting infected.
Although there are no currently approved treatments for COVID-19, both drugs have shown activity in laboratory studies against the disease. To date, no clinical trial demonstrating such effectiveness is completed.
The US Department of Health stated that “anecdotal reports suggest that these drugs may offer some benefit in the treatment of hospitalized COVID-19 patients,” adding that “clinical trials are needed to provide scientific evidence that these treatments are effective.”
According to the US Center for Disease Control and Prevention, both forms of the drug have shown in-vitro activity against various forms of coronavirus, with a further study in China reporting that chloroquine treatment of COVID-19 patients displayed clinical and virologic benefit against a comparison group.
Following the developments, manufacturers of the substances announced that they are scaling up production of the drugs, with several companies including Novartis, Teva, and Bayer, donating significant amounts of the product to the US Strategic National Stockpile.