The World Health Organization (WHO) accepted the recommendation from the Solidarity Trial’s International Steering Committee to discontinue the trial’s hydroxychloroquine and lopinavir/ritonavir arms. The Solidarity Trial was established by WHO to find an effective COVID-19 treatment for hospitalized patients. WHO has based its decision on the International Steering Committee recommendation in light of the evidence for hydroxychloroquine versus standard of care and for lopinavir/ritonavir versus standard care from the Solidarity trial interim results, and a review of the evidence from all trials presented at their 1-2 July WHO summit on COVID-19 research and innovation. This decision is only for hospitalized patients and the organization may continue to use these drugs in earlier-stage cases.
The WHO Results
In a press release, WHO declared that the interim results for these drugs reveal little or no reduction in the mortality of hospitalized COVID-19 patients when compared to standard of care. Hence, Solidarity trial investigators will interrupt the trials with immediate effect.
WHO declared in their press release that the interim results from the study doesn’t provide enough evidence to proceed. They note that there were some associated safety signals in the clinical laboratory findings of the add-on Discovery trial, a participant in the Solidarity trial. WHO committed to include this data in their forthcoming peer-reviewed publication.
Only for Hospitalized Patients
This decision applies only to the conduct of the Solidarity trial in hospitalized patients and does not affect possible evaluation in other studies of hydroxychloroquine or lopinavir/ritonavir in non-hospitalized patients or as pre- or post-exposure prophylaxis for COVID-19. The interim Solidarity results are now being readied for peer-reviewed publication.
There was high hopes for the use of hydroxychloroquine among clinicians and investigators worldwide. Due to a number of dynamics it became a controversial topic. It’s unfortunate that such drama has been bestowed on a drug that many physicians articulate, if administered early, may have a positive impact on COVID-19 patients. WHO has clearly accumulated enough evidence to make the decision that it doesn’t help in hospitalized patient situations. This makes sense based on what several physicians have shared with TrialSite News. That any purported benefit of this drug would be involved with early onset treatment not as it has progressed and hospitalization involved.
TrialSite News also recently reported on the results from the Henry Ford Health System’s hydroxychloroquine study results in Detroit where death rates were reduced. And in another recent French study, although not peer reviewed as of yet, the authors articulate that upon receiving hydroxychloroquine and azithromycin and zinc, the treatment group were hospitalized at 2.8% while the non-treatment group was hospitalized at 15.4%. These French investigators argue based on these results that if COVID-19 patients are treated early—at symptom onset—with this triple therapy that hospitalization and death rates significantly drop.
There are many hydroxychloroquine studies ongoing that TrialSite News will monitor in an attempt to update the TrialSite Network with as much relevant information as possible. The hope is to keep the politics and drama away from the actual work of investigator and clinicians, and their dedicated staff, working furiously and tirelessly to treat COVID-19 patients and save lives.
Paul Aukrust, MD, Oslo University Hospital
Andreas Baratt-Due, MD, Oslo University Hospital
Call to Action: For WHO updates on the Solidarity Trial, see this link.