Recruitment to the RECOVERY trial (including the Hydroxychloroquine arm) REMAINS OPEN
▻https://www.recoverytrial.net/files/professional-downloads/recovery_noticetoinvestigators_2020-05-24_1422.pdf
Après évaluation de résultats préliminaires (motivée par les mauvais résultats de l’étude Mehra et al), l’étude prospective randomisée britannique #RECOVERY est autorisée à se poursuivre en maintenant l’#HCQ dans son protocole.
On Friday 22nd May we received a letter from the MHRA in which they notified us of their concerns relating to the use of #hydroxychloroquine as a treatment for patients with #COVID-19 in the light of the recent publication by Mehra et al in The Lancet on 22 May 2020.
We have held two videoconferences with the MHRA and provided a detailed response [...].
This morning we have received written confirmation from the MHRA that, “it is acceptable to allow continued randomisation into the hydroxychloroquine arm of the trial.”
[..,]
• The RECOVERY trial is currently the largest randomised controlled trial of HCQ for COVID-19 but is not yet sufficiently large to detect (or rule out) moderate yet important treatment effects.
[...]
•In response to the letter provided by MHRA, the Chair of the independent DMC conducted an urgent review of unblinded data for the HCQ vs. Standard of Care comparison within RECOVERY. Following an initial review by the DMC Chair and further discussions between the RECOVERY Chief Investigators and the MHRA, the independent Data Monitoring Committee then held a full meeting by videoconference and issued a letter indicating that, “the Data Monitoring Committee saw no cogent reason to suspend recruitment for safety reasons and recommended the trial continue recruitment without interruption.”
•Given the additional review of unblinded data conducted by the full independent Data Monitoring Committee yesterday and their recommendation to continue without interruption, it is the view of the Chief Investigators that any pause in recruitment would be unjustified and would not be in the interests of trial participants or public health.
•The RECOVERY trial provides the best and most rapid opportunity to produce robust information on the overall effects of HCQ on the risk of death from COVID-19. These results will be of huge importance to the millions of patients who are (or will be) treated with HCQ and could have a major impact on a disease that has already caused hundreds of thousands of deaths.