Novartis says it has reached an agreement with the US FDA to proceed with a phase 3 clinical trial of hydroxychloroquine in patients hospitalised with COVID-19 disease.
Hydroxychloroquine, which is used for lupus and rheumatoid arthritis, is one of several symptomatic treatments currently being investigated for use against COVID-19.
The Australian government is one of many to acquire stock of hydroxychloroquine in response to the pandemic. The US government has stockpiled almost 30 million doses of the drug that is unproven as a treatment for COVID-19 with mixed results in trials.
Novartis has committed to donate up to 130 million tablets of hydroxychloroquine to supply global clinical research efforts.
Yet speculation of its potential efficacy has led to its short supply in Australia.
In a statement, Novartis said the phase 3 trial will involve approximately 440 patients, with the drug supplied by its Sandoz generics and biosimilars division.
The company said the trial will be conducted at more than a dozen sites in the US and that it plans to begin enrollment within the next few weeks. It said it "is committed" to reporting results as soon as possible.
Novartis also said it will make any intellectual property within its control that relates to the use of hydroxychloroquine to treat or prevent COVID-19 available through non-exclusive voluntary licenses, appropriate waivers, or similar mechanisms.
“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. “We mobilized quickly to address this question in a randomized, double-blind, placebo-controlled study.”
Novarits said patients in the trial will be randomised into three groups.
The first group or arm will receive hydroxychloroquine. The second group will receive hydroxychloroquine in combination with the antibiotic azithromycin. The third group will receive placebo.
Patients in all treatment groups are receiving standard of care for COVID-19.
"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 disease treatments," said the company in a statement.
“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,” said Richard Saynor, CEO of Sandoz.
“We will continue to fulfill orders for existing customers to ensure the medicine remains available to US patients who rely on it for other indicated uses.”