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An NIH trial on the controversial anti-malaria medication is underway.
The price of hydroxychloroquine sulfate, which some hospitals are using to treat seriously ill coronavirus (COVID-19) patients, has skyrocketed.
At the same time, a major new U.S. clinical trial on the drug to treat COVID-19 is getting underway.
Spectrum Chemical, a key active ingredient supplier of hydroxychloroquine sulfate to compounding pharmacies, increased the ingredient’s price by around 350%, Stat news reported.
The new price for a 100-gram container is around $1,160, while the price of a 1,000-gram container soared 230% to $5,932, Stat found.
The sudden demand for the drug has made it more difficult to obtain the active ingredient which affects its acquisition costs, a Spectrum spokesperson told Stat.
“The result of all these current crisis challenges is that availability, prices and delivery dates to our customers will fluctuate,” the spokesperson said.
While President Donald Trump publicly supports the use of hydroxychloroquine, Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases at the National Institutes of Health (NIH) and other experts note that there is only anecdotal information that hydroxychloroquine works to combat COVID-19.
To help provide more accurate data on the drug, the NIH just began its Outcomes Related to COVID-19 treated with hydroxychloroquine among In-patients with symptomatic Disease study (ORCHID) Study.
The first participants have enrolled in the trial at Vanderbilt University Medical Center in Nashville, TN. The blinded, placebo-controlled randomized clinical trial aims to enroll more than 500 adults who are currently hospitalized with COVID-19 or in an emergency department with anticipated hospitalization, NIH said in a press release.
“Effective therapies for COVID-19 are urgently needed,” said James P. Kiley, director of the Division of Lung Diseases at the National Heart, Lung, and Blood Institute (NHLBI), part of NIH. “Hydroxychloroquine has showed 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,” Kiley added.
Hydroxychloroquine is used to treat malaria and rheumatoid conditions such as arthritis. In various studies, 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, NIH said.
“Many U.S. hospitals are currently using hydroxychloroquine as first-line therapy for hospitalized patients with COVID-19 despite extremely limited clinical data supporting its effectiveness,” said Wesley Self, MD, MPH, emergency medicine physician at Vanderbilt University Medical Center and PETAL Clinical Trials Network investigator leading the ORCHID trial. “Thus, data on hydroxychloroquine for the treatment of COVID-19 are urgently needed to inform clinical practice.”
The drug’s risks include cardiac arrythmias, seizures, dermatological reactions, and hypoglycemia, NIH said.