A human clinical trial for an antimalarial drug touted as a possible treatment option for patients with COVID-19 infections began this week, according to the National Institute of Health (NIH).
The NIH in a news release on Thursday said a clinical trial for the drug hydroxychloroquine began with the first participants enrolled at Vanderbilt University Medical Center in Nashville, Tenn. The trial involves some 500 adults “who are currently hospitalized with COVID-19 or in an emergency department with anticipated hospitalization,” officials said.
The trial is placebo-controlled and randomized, meaning some of the patients will be treated with hydroxychloroquine while others will not. However, “all participants in the study will continue to receive clinical care as indicated for their condition,” the NIH said.
The drug recently made headlines when it was touted as a possible treatment for COVID-19. But the effectiveness of hydroxychloroquine has been a source of debate within the medical community, with some warning it’s too soon to know if it’s an efficacious option in treating patients with the novel virus.
Theoretically, the drug, with its ability to quiet an immune system response, could help prevent a COVID-19 infected person’s immune system from going into overdrive, attacking the virus so vigorously that it ultimately causes organ failure and death, as has occurred in some patients. Though preliminary studies have shown the drug protects lab-grown cells from the virus, the human clinical trial is aimed at evaluating its “safety and effectiveness” in treating coronavirus patients, according to the NIH.
The drug has also faced shortages since being touted as a possible treatment option, namely affecting lupus patients who depend on it to treat the auto-immune disorder.
“The drug has demonstrated antiviral activity, an ability to modify the activity of the immune system, and has an established safety profile at appropriate doses, leading to the hypothesis that it may also be useful in the treatment of COVID-19,” the NIH said in the news release, though warned: “The drug is not without risks as even short term use can cause cardiac arrhythmias, seizures, dermatological reactions, and hypoglycemia.”
“Effective therapies for COVID-19 are urgently needed,” James P. Kiley, the director of the Division of Lung Diseases at the National Heart, Lung, and Blood Institute (NHLBI), which is part of the NIH, said in a statement.
“Hydroxychloroquine has [shown] promise in a lab setting against SARS-CoV-2, the virus that causes COVID-19 and preliminary reports suggest potential efficacy in small studies with patients. However, we really need clinical trial data to determine whether hydroxychloroquine is effective and safe in treating COVID-19,” he added.