The Medicines and Healthcare products Regulatory Agency (MHRA) has instructed UK clinical trialists using hydroxychloroquine to treat or prevent coronavirus (COVID-19) to suspend recruitment of further participants.
This means that 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 1 and 5 June 2020 and reviewed the data that had been submitted for each trial in response to MHRA requests.
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.
Hydroxychloroquine and chloroquine licensed in the UK
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. These products should only be taken if prescribed by a healthcare professional and supplied by or under the supervision of a pharmacist on registered pharmacy premises.
Patients or healthcare professionals can report any suspected side effects from hydroxychloroquine or chloroquine taken by patients with COVID-19 via our Yellow Card COVID-19 reporting site.
If you would like to report any suspected side effects from hydroxychloroquine or chloroquine taken to treat other health conditions, please use our main Yellow Card site