The University of Oxford is to restart its trial of hydroxychloroquine for the prevention of COVID-19, after the Medicines and Healthcare products Regulatory Agency (MHRA) gave the green light to begin recruiting more participants.
Recruitment of participants was suspended earlier this month after the MHRA instructed UK clinical trialists using hydroxychloroquine to treat or prevent coronavirus (COVID-19) to suspend recruitment of further participants.
This decision followed advice from the Commission on Human Medicines, which reviewed the data that had been submitted for each trial in response to MHRA requests.
However, on 17 June, the MHRA received a request from the University of Oxford to recommence recruitment to the 'COPCOV' trial investigating hydroxychloroquine in the prevention of COVID-19. The submitted justifications and supporting information were reviewed by the MHRA, with independent advice obtained from the Commission on Human Medicines. On 26 June 2020 it was agreed that sufficient measures had been taken to support the safe recruitment of further participants.
Dr Siu Ping Lam, Director of Licensing at the MHRA, said: “We have reviewed the University of Oxford’s request to recommence recruitment for the ‘COPCOV’ trial, investigating the use of hydroxychloroquine in the prevention of COVID-19. After analysing the additional risk mitigations and consulting the Commission on Human Medicines, we have given the clinical trial the green light to recruit more participants.”
“Participant safety is our priority, so we will continue to monitor the trial to ensure ongoing appropriate measures are in place to maintain continued high levels of safety,” he said.