Urgent Need for More Data and Collaboration to Guide the Use of Antimalarials for COVID-19
Arlington, VA (April 3, 2020) –
The ongoing pandemic of COVID-19 understandably has the world and the scientific community searching relentlessly for solutions, including effective treatments. We note that the FDA has acted under its authority through the Emergency Use Authorization to provide assistance in a public health emergency to provide Emergency Use Authorization of the antimalarial and anti-inflammatory 4-aminoquinolines chloroquine and hydroxychloroquine for the treatment or prevention of COVID-19. Since our founding in 1903, malaria has been a central focus for ASTMH. We are a member of FDA’s Network of Experts, and we have pledged to the FDA access to ASTMH member malariologists who have specialized scientific or medical expertise to offer during this rapidly evolving public health emergency as this new treatment is further used and evaluated. As a Society, we are eager to help.
Surging demand for hydroxychloroquine for management of COVID-19 risks the loss of drug availability for many patients with systemic lupus erythematosus or rheumatoid arthritis, for which the drug is clearly indicated. The two randomized clinical trials of hydroxychloroquine for COVID-19 reported to date had small numbers of patients and methodological limitations, and they produced conflicting results. In addition, two small non-randomized studies of treatment with the combination of hydroxychloroquine and azithromycin have been reported. In both of these studies, many of the enrolled patients had mild disease, so the need for treatment in those patients was unclear. Side effects of chloroquine and hydroxychloroquine can be substantial with pre-existing, especially cardiovascular, conditions--notably arrhythmias. The combination of hydroxychloroquine and azithromycin may increase the risk of arrhythmia.
There is an urgent need for additional evidence from carefully designed, randomized treatment and prevention trials with new and old compounds to guide the use of any treatment regimen, especially for widespread use in COVID-19, as outlined in a review published online April 3 in The American Journal of Tropical Medicine and Hygiene
. Thus, we strongly encourage collecting additional data on the use of antimalarials, randomized clinical trials to provide the best evidence concerning both efficacy and safety of these drugs in COVID-19, the timely sharing of data, and collaboration across sites to support evidence-based decision making and quality care. Only by working together can we find the best solutions to this global crisis.
The American Society of Tropical Medicine and Hygiene (ASTMH) remains dedicated to our mission of excellence and rigor in science dedicated to reducing the worldwide burden of tropical infectious diseases and improving global health.