Swiss pharmaceutical giant Novartis said Monday it would sponsor a clinical trial in the US using hydroxychloroquine to treat patients hospitalised with COVID-19.
Novartis said it had reached an agreement with the US food and Drug Administration (FDA) to go ahead with a phase III clinical trial with around 440 patients to evaluate whether the drug is efficient in treating coronavirus, which has killed more than 164,000 people worldwide in a matter of months.
The company said its Sandoz division would supply the drugs needed for the trial, which would be conducted at more than a dozen sites in the United States starting within the next few weeks.
Hydroxychloroquine has been used for decades against malaria and is being tested worldwide against the virus along with another anti-malarial drug, chloroquine.
Both have potentially serious side effects, and a range of clinical trials are now underway to determine their efficacy and safety.
“We recognise the importance of answering the scientific question of whether hydroxychloroquine will be beneficial for patients with COVID-19 disease,” John Tsai, Novartis Chief Medical Officer said in the statement.
“We mobilised quickly to address this question in a randomised, double-blind, placebo-controlled study,” he added.
Hydroxychloroquine has shown early promise against COVID-19 in small-scale studies in France and China to reduce virus levels among people badly infected.
US President Donald Trump has touted it as a coronavirus treatment and in the US a limited emergency-use authorisation has been granted to the drug.
But many scientists are urging caution until larger trials show whether it is safe and effective.
Source: Guardian Newspaper
