Update on hydroxychloroquine and the Solidarity Trial

GENEVA [ENA] Update on hydroxychloroquine and the Solidarity Trial: On 17 June 2020, WHO announced that the hydroxychloroquine (HCQ) arm of the Solidarity Trial to find an effective COVID-19 treatment was being stopped. The trial's Executive Group and principal investigators made the decision based on evidence from the Solidarity Trial, UK's Recovery trial and a Cochrane review of other evidence on hydroxychloroquine.

Data from Solidarity (including the French Discovery trial data) and the recently announced results from the UKs Recovery trial both showed that hydroxychloroquine does not result in the reduction of mortality of hospitalised COVID-19 patients, when compared with standard of care. Investigators will not randomize further patients to hydroxychloroquine in the Solidarity trial. Patients who have already started hydroxychloroquine but who have not yet finished their course in the trial may complete their course or stop at the discretion of the supervising physician.

This decision applies only to the conduct of the Solidarity trial and does not apply to the use or evaluation of hydroxychloroquine in pre- or post-exposure prophylaxis in patients exposed to COVID-19. In light of recent publications of evidence on the safety and efficacy of hydroxychloroquine as a treatment for COVID-19 patients, the Executive Group of the Solidarity Trial decided to implement a temporary pause of the hydroxychloroquine arm within the trial as a precaution while the safety data is being reviewed.

As an example, an observational study published in the Lancet on 22 May found that, among 100 000 patients from multiple countries randomized to receive hydroxychloroquine, when used alone or with a macrolide, there was a higher mortality rate and an increased frequency of irregular heartbeats. A final decision on the harm, benefit or lack of benefit of hydroxychloroquine will be made once the evidence has been reviewed by the Data Safety Monitoring Board. This review will include data from the Solidarity Trial and other ongoing trials, as well as any evidence published so far. It is expected by mid-June.

What is the Solidarity Trial? The Solidarity Trial is an international clinical trial to help find an effective treatment for COVID-19, launched by WHO and partners. It is hoped that one or more of the treatments under trial will result in improving clinical outcomes in COVID-19 patients and save lives. Other trials are on-going around the world in addition to the Solidarity Trial.

Based on data from laboratory and clinical studies, Remdesivir, Lopinavir/Ritonavir, Lopinavir/Ritonavir with Interferon beta-1a, and hydroxychloroquine had been initially selected as treatment options. Following new evidence on the safety and efficacy of hydroxychloroquine as a treatment for hospitalized COVID-19 patients, enrollment for this drug was temporarily suspended on 24 May 2020. Over 100 countries have expressed an interest in participating in the trial and WHO is actively supporting more than 60 of them, including with the following:

° ethical and regulatory approvals of the WHO core protocol; ° identification of hospitals participating in the trial; ° training of hospital clinicians on the web-based randomization and data system; ° shipping the trial drugs as requested by each participating country. To date, over 400 hospitals in 35 countries are actively recruiting patients and nearly 3500 patients have been enrolled from 17 countries. An interim trial analysis will be produced and will be monitored by an independent group of experts as the global Data and Safety Monitoring Committee.