The World Health Organization has officially accepted a crucial recommendation from the International Steering Committee of the Solidarity Trial to immediately discontinue the trial’s hydroxychloroquine and lopinavir/ritonavir treatment arms. The global Solidarity Trial was originally established by the World Health Organization to find an effective, life-saving COVID-19 treatment specifically tailored for hospitalized patients battling the severe manifestations of the coronavirus disease.
The International Steering Committee formulated this definitive recommendation in light of mounting evidence concerning hydroxychloroquine versus standard-of-care, as well as lopinavir/ritonavir versus standard-of-care. This decision was reached following a comprehensive review of interim results generated directly by the Solidarity trial, alongside a broader, meticulous review of evidence from all clinical trials presented during the recent World Health Organization Summit on COVID-19 research and innovation, which took place on July 1 and 2.
The interim trial results clearly demonstrate that both hydroxychloroquine and lopinavir/ritonavir produce little or no reduction in the overall mortality rates of hospitalized COVID-19 patients when compared directly against the standard of care administered in participating medical centers around the world. In response to these findings, Solidarity trial investigators are interrupting the administration of these specific treatments within the trial with immediate effect to ensure patient safety and optimize the allocation of ongoing research resources.
For each of the two evaluated drugs, the interim results do not provide solid, definitive evidence of increased mortality among the patient cohorts. There were, however, some notable and associated safety signals identified in the clinical laboratory findings of the add-on Discovery trial, which operates as a closely integrated participant in the broader Solidarity trial framework. These specific laboratory safety signals will also be thoroughly detailed and reported in the upcoming peer-reviewed publication of the trial findings.
It is important to note that this critical decision applies strictly and exclusively to the conduct of the Solidarity trial in hospitalized patients. The discontinuation does not affect the possible evaluation in other ongoing or future studies investigating hydroxychloroquine or lopinavir/ritonavir in non-hospitalized patients, nor does it impact their potential study as pre-exposure or post-exposure prophylaxis for COVID-19 prevention. The interim Solidarity results are currently being readied for formal peer-reviewed publication to ensure transparency and to share the data with the global medical and scientific community.
The information regarding these trial developments was provided by Daniela Bagozzi, Senior Information Officer.
