President Donald Trump recently called chloroquine and hydroxychloroquine a “game changer.” His remarks have led to a rush in demand for the decades-old antimalarials. Novartis has announced it is proceeding with a Phase III trial for hydroxychloroquine. Should we be reassured?
HDQ is an inexpensive, scaled drug that is FDA-approved for rheumatoid arthritis and malaria, not for COVID-19. The World Health Organization originally did not select it to be an effective therapy for COVID-19, nor do I. Its endosomal lysis mode of action is not very relevant to COVID-19 spike protein cellular entry until high doses are administered and all trials to date have been underpowered and without random/placebo controls. The U.S. Society of Critical Care Medicine wrote last week: “There is insufficient evidence to issue a recommendation on the use of chloroquine or hydroxychloroquine in critically ill adults with COVID-19.”
Novartis and several others are conducting trials, prompted more by a desire to protect existing markets than to pursue promising science–there have been no studies conclusively demonstrating efficacy against COVID. Unfortunately, Trump’s ungrounded enthusiasm has distracted them from pursuing more promising alternatives. For a detailed discussion of the studies and their results, I suggest you look at Kai Kupferschmidt, Jon Cohen’s excellent article in Science Magazine. https://www.sciencemag.org/news/2020/03/who-launches-global-megatrial-four-most-promising-coronavirus-treatments
Patients can ask their doctor for the drug for off-label use. It will likely have to be used in the hydroxy form with an antibiotic. They should be aware that Hydroxychloroquine has significant side effects at the likely effective dose required to knock down a novel virus. At high doses, HDQ can harm the heart.
In my opinion, among existing therapies, COVID-19 convalescent therapy antibodies or Remdesivir, are better options.