Treatment of COVID-19: Hydroxychloroquine and Chloroquine [Updated May 27, 2020]   [open pdf - 649KB]

From the Document: "To date, the U.S. Food and Drug Administration (FDA) has not approved any therapeutics--drugs or biologics--for the treatment of COVID-19 [coronavirus disease 2019]. However, FDA has authorized the emergency use of three drugs, including two drugs that have been approved by FDA for other uses: hydroxychloroquine sulfate ('hydroxychloroquine') and chloroquine phosphate ('chloroquine'). The agency authorized the emergency use of both drugs on March 28, 2020. [...] Some stakeholders--including several former FDA officials--have expressed concern regarding FDA's EUA [emergency use authorization], stating that current data regarding the safety and effectiveness of these drugs for treatment of COVID-19 are largely anecdotal and that expanding access may jeopardize research into the drug. On April 24, 2020, FDA issued a drug safety communication warning against the use of these drugs for treatment of COVID-19 outside of the hospital setting or a clinical trial due to risk of heart rhythm problems. Further, the National Institutes of Health (NIH) treatment guidelines on use of antivirals for COVID-19 state that '[t]here are insufficient clinical data to recommend either for or against using chloroquine or hydroxychloroquine for the treatment of COVID-19' and recommend against using high-dose chloroquine for the treatment of COVID-19."