Swiss drugmaker Novartis gained permission from the U.S. Food and Drug Administration to test hydroxychloroquine, a malaria drug being widely used against COVID-19, against the new disease from China.
COVID-19 is caused by the CCP (Chinese Communist Party) virus, a novel coronavirus.
Hydroxychloroquine is being prescribed by doctors across the United States and is believed to be the most effective treatment against COVID-19, but some medical experts say more data is needed to prove it works.
The phase 3 clinical trial that Novartis plans will include about 440 hospitalized patients across more than a dozen hospitals in the United States. Enrollment will start within the next few weeks and the drugmaker is promising to report results “as soon as possible.”
“We recognize the importance of answering the scientific question of whether hydroxychloroquine will be beneficial for patients with COVID-19 disease,” said John Tsai, head of Global Drug Development and Chief Medical Officer at Novartis, in a statement.
Researchers at the company compressed months of work into a few weeks to design the large clinical trial in order to rapidly respond to the need for COVID-19 treatments, according to the company.
One group of patients will get hydroxychloroquine, a second will receive the drug in combination with the antibiotic azithromycin, and a third will get a placebo.
The trial will be randomized and double-blind.
Doses of hydroxychloroquine will be provided by Sandoz, a division of Novartis. The company said last month it was committing to donating up to 130 million doses of hydroxychloroquine to support worldwide efforts against COVID-19. That included a stockpile of 50 million 200 microgram doses the company had.
In an update Monday, the company said it donated 30 million tablets to the U.S. Department of Health and Human Services and is sending shipments to other countries based on requests from governments.
“We are donating hydroxychloroquine tablets for COVID-19 patients including for use in this and other clinical trials with the hope that researchers and healthcare workers can quickly and scientifically determine whether hydroxychloroquine can help patients around the world combat this disease,” Richard Saynor, CEO of Sandoz, said in a statement. “We will continue to fulfill orders for existing customers to ensure the medicine remains available to U.S. patients who rely on it for other indicated uses.”
Besides the treatment of malaria, the drug is used to treat lupus and rheumatoid arthritis.
Multiple trials studying the safety and efficacy of hydroxychloroquine are already underway in the United States, including a 1,500-patient trial run by University of Minnesota researchers and a trial headed by National Institutes of Health scientists.