Misleading Headlines About the Hydroxyquinoline Trials

Today, several news sources are running with headlines that the WHO has stopped testing hydroxychloroquine. That is misleading. There are several arms to the WHO trials and they are pausing ONE of them due to what is called, interim stopping rules that can be triggered by what is called an interim data analysis.

Interim data analysis is when, at specific points of a clinical trial, an independent panel not involved in the research unblinds the research data in order to assess whether the study is progressing as planned and that study measures will be met. This interim analysis also looks for unanticipated side effects that occur too often. If this interim data analysis raises alarms the independent panel can halt the trial for further data analysis and discussion. Specific criteria that would trigger such pauses are required to be built into any clinical study in order to protect study subjects from undue harm. Sometimes studies are shut down early simply because the data show that investigators will not be able to recruit sufficient numbers of study participants and it would be unethical to continue exposing subjects to experimental therapies if the study will not be able to reach any definitive conclusion.

Apparently, in this case, the study arm treating advanced COVID-19 patients is being paused so that the independent panel can further assess whether the drug is causing an unacceptable incidence of cardiovascular events. Preliminary statements suggest that that could be happening, but we won't know for sure until the unblinded data are more thoroughly examined. It is quite possible that there are unacceptable side effects on this cohort of patients.

HOWEVER, other arms of the study on patients without advanced disease and prophylactic studies of uninfected patients will continue. Despite the cryptic and misleading headlines, trials of hydroxychloroquine continue as of this writing. In other words.....

...we will see.