MHRA suspends patient recruitment to UK COVID-19 hydroxychloroquine trials

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has announced that UK clinical trials investigating hydroxychloroquine to treat or prevent COVID-19 are to suspend recruitment of further participants.

As such, no new participants will be enrolled 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 1 and 5 June 2020 and reviewed the data that had been submitted for each trial in response to MHRA requests.

According to the MHRA, it followed the emerging concerns about the 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 Chief Executive Officer, 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.”

The MHRA highlights that hydroxychloroquine and chloroquine are licensed in the UK to treat different health conditions such as malaria, rheumatoid arthritis, lupus, amoebic hepatitis and abscess and certain dermatological conditions. 

Patients or healthcare professionals can report any suspected side effects from hydroxychloroquine or chloroquine taken by patients with COVID-19 the the MHRA via the  Yellow Card COVID-19 reporting site.