Novartis to sponsor large clinical trial of hydroxychloroquine in COVID-19 patients
pharmafile | April 20, 2020 | News story | Sales and Marketing | COVID19 Coronavirus, coronavirus, covid19
The FDA and Novartis have agreed to move forward with a Phase 3 clinical trial to evaluate the effectiveness of hydroxychloroquine in COVID-19 patients.
440 patients will participate in the trial and it will be conducted at more than a dozen sites in the US. Patients in the trial will be put into three randomized groups, with the first group receiving just hydroxychloroquine, the second receiving hydroxychloroquine in combination with azithromycin while the third will receive a placebo.
On the planned trial, John Tsai, Head of Global Drug Development and Chief Medical Officer at Novartis, said: “We recognize the importance of answering the scientific question of whether hydroxychloroquine will be beneficial for patients with COVID-19 disease. We mobilized quickly to address this question in a randomized, double-blind, placebo-controlled study.”
This follows Novartis donating 130 million tablets of hydroxychloroquine to supply global research efforts into the treatment.
CEO of Sandoz, Richard Saynor, commented on the drug saying that: “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. “
We will continue to fulfil orders for existing customers to ensure the medicine remains available to US patients who rely on it for other indicated uses.”
Novartis has also created a team to provide rapid access for approved clinical requests and support of clinical evaluation of its medicine to be repurposed to be used in COVID-19 treatments.
Conor Kavanagh
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