Novartis has terminated its sponsored hydroxychloroquine clinical trial for COVID-19 due to acute enrolment challenges that have made trial completion “infeasible”.
The drug giant said that slow trial recruitment has made it unlikely that the clinical team will be able to collect meaningful data in a reasonable timeframe to determine the effectiveness of the drug in treating patients with the virus.
It was also stressed that no safety issues have been reported, and that conclusions on efficacy have been made from the study.
Novartis will continue to provide supply hydroxychloroquine for ongoing investigator-initiated trials (IITs) and upon government requests, as appropriate, where certain conditions are met and the medicine is used in accordance with a nationally endorsed treatment protocol.
Also, the firm said it would “continue to monitor ongoing guidance from health authorities on the further study of hydroxychloroquine for COVID-19”, as well as the decision by the US Food and Drug Administration to stop its emergency use authorisation of the drug in this setting.
22nd June 2020