Novartis is investigating hydroxychloroquine in Covid-19-STAT

T.Drug giant Novartis said on Monday that it would conduct a 450-person study to determine whether hydroxychloroquine, the malaria drug touted by many experts and President Trump, Covid-19, can effectively treat the disease caused by the novel coronavirus.

The trial will be a randomized, double-blind, placebo-controlled trial, the gold medical standard in which patients are assigned one of three options: hydroxychloroquine, the combination of hydroxychloroquine, and the antibiotic azithromycin or placebo.

“We felt that there was only a lot of noise out there, whether this was an advantage for this patient population [it] could be really helpful, ”said John Tsai, Novartis’ chief medical officer, in an interview. “So we wanted to take a rigorous, scientifically-led approach to answer the unanswered question of whether using hydroxychloroquine can help patients with Covid-19.”

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The study will not include patients who are very ill and are wearing ventilators. This includes adults who are admitted to the hospital and who are in a population described by doctors as moderately difficult to difficult, for example those who need an oxygen supplement.

Patients receive a loading dose of 600 milligrams of hydroxychloroquine and then 200 mg three times a day. Tsai said there is “a narrow window” to keep drug levels high enough that they may have antiviral activity without causing too many side effects, such as: B. Changes in the heart rhythm that the medicine can cause. The study will be conducted at more than a dozen locations in the United States and will begin in the next few weeks.

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Hydroxychloroquine was originally approved by the Food and Drug Administration in April 1955. It was one of the first potential agents that showed the ability to slow down SARS-CoV-2, the novel coronavirus, in a laboratory. While such results are a useful scientific advance, they are not often This leads to effectiveness in infected people.

A series of small studies, most of which were not randomized (for example, compared some patients who agreed to take the drug with those who did not) and who were not blind (doctors and patients knew who was taking which drug) ) showed conflicting results. A French study showed a dramatic decrease in blood levels of the SARS-CoV-2 virus with the combination of hydroxychloroquine and azithromycin, the antibiotic that Pfizer once sold as Zithromax.

However, excitement about the medication has resulted in hydroxychloroquine being routinely used in the sickest Covid-19 patients, and there have been concerns that patients with other conditions that treat the drug, such as lupus, could not get it.

Most drug trials are conducted by pharmaceutical companies to increase the use of new drugs that are still patented, giving them a monopoly on drug sales. For older generics like hydroxychloroquine, there are many manufacturers, none of which are likely to generate enough revenue to pay the bill.

However, Tsai said Novartis, which manufactures a generic version of hydroxychloroquine through its Generics division, Sandoz, felt responsible for conducting the clinical trial.

“We felt obliged to start a study to understand the scientific question,” said Tsai. “That’s why we continued this study. There is no financial incentive for us per se.”

Novartis has already announced that it will donate 130 million doses of hydroxychloroquine to governments around the world, including 30 million that have been administered to the United States.

The study is led by Richard E. Chaisson, a professor of medicine, epidemiology and international health at Johns Hopkins University.

“Although hydroxychloroquine is very enthusiastic, it is important to subject the compound to rigorous, science-based testing to determine its effectiveness and safety.”
Chaisson said in a statement.

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