ZURICH (Reuters)—Swiss drugmaker Novartis AG says it will test the malaria drug hydroxychloroquine (HCQ) in a randomized trial to see if the much talked about medicine is actually effective against COVID-19, the illness caused by the novel coronavirus.
The company hopes to have data on its efficacy by June, a lead researcher for the trial tells Reuters.
The decades-old generic medicine has been touted by U.S. President Donald Trump and others as a “game changer” treatment for the highly contagious respiratory illness, and the U.S. Food and Drug Administration (FDA) authorized it use in COVID-19 on an emergency basis. But there is not yet scientific proof that it works.
There are currently no approved medicines or vaccines specifically for COVID-19.
“Right now, we’re in a sea of anecdotes, and a lot of non-professional, poorly-informed people are making recommendations that are swaying how the public and patients view this [drug],” Richard Chaisson, MD, the Johns Hopkins University professor leading the trial, says in an interview.
Novartis says it got the go-ahead from the FDA for the trial and it hopes to start recruiting 440 patients within weeks at more than a dozen U.S. sites. Results will be reported as soon as possible, the company adds.
Use of the drug, which is also approved to treat lupus and rheumatoid arthritis, has soared since Trump started promoting it. But critics have expressed concern that the administration’s advocacy for an unproven medicine has short-circuited the FDA’s oversight process.
“We recognize the importance of answering the scientific question of whether HCQ will be beneficial for patients with COVID-19 disease,” says John Tsai, Novartis’s top drug developer. “We mobilized quickly to address this question in a randomized, double-blind, placebo-controlled study.”
Companies, such as Novartis, Roche and Gilead Sciences, are testing older medicines developed to treat other diseases, for signs they could be repurposed to tackle the coronavirus epidemic. Gilead just expanded a trial of its antiviral drug remdesivir, which previously failed as a treatment for Ebola.
Still, some fear the championing of HCQ for COVID-19 has overshadowed potentially dangerous side effects, such as vision loss and heart problems. Novartis Chief Executive Vas Narasimhan has also says the medicine is one of his biggest hopes against the pandemic.
Dr. Chaisson says many of the clinical trials to research the drug are “either small or uncontrolled or overly ambitious.” He says the Novartis trial is designed to test the drug’s effectiveness quickly, and could yield results in June.
There are several additional studies of HCQ underway, including at the University of Washington and University of Minnesota, as well as work by the National Institutes of Health in the U.S.
Novartis’s Sandoz generics unit has pledged to donate 130 million doses of the medicine for use. Sanofi has also said it will donate 100 million doses of HCQ to 50 countries.
