The Medicines and Healthcare products Regulatory Agency (MHRA) has instructed UK clinical trialists using hydroxychloroquine to treat or prevent coronavirus to suspend recruitment of further participants.
The latest move follows emerging concerns about the use of the drug, and a trial which found no meaningful mortality benefit in patients hospitalised with Covid-19.
According to the latest move no new participants will be recruited to these trials until further data which justifies their continuation have been provided, and any additional safety measures have been implemented.
This decision follows advice from the Commission on Human Medicines, which met on June 1 and 5, 2020 and reviewed the data that had been submitted for each trial in response to MHRA requests.
MHRA said in a release: “We followed the emerging concerns about use of hydroxychloroquine in Covid-19, and took into consideration the results from two different trials, including the UK’s RECOVERY trial which has provided convincing evidence of no meaningful mortality benefit in hospitalised patients with Covid-19.”
Dr June Raine, MHRA’s CEO, said: “We have told those conducting clinical trials using hydroxychloroquine to treat or prevent Covid-19 to suspend recruitment into their trials.
“Neither hydroxychloroquine nor chloroquine are licensed to treat Covid-19 related symptoms or to prevent infection.
“It is important to note that patients taking hydroxychloroquine and chloroquine to treat other health conditions can continue to do so, as advised by their healthcare professional, as the balance of benefits and risks remains favourable in the licensed uses.”
