The drug gained notoriety as Covid-19 spread through Europe in March, when French researchers reported that it had improved the condition of a handful of patients. Experts elsewhere, including in India, later recommended it as a prophylactic for health-care workers. And US President Donald Trump has touted the drug for weeks, even saying that he, too, was taking it preventatively. However, systematic data has been sorely lacking. So one arm of the WHO-cosponsored Solidarity trial, was set to examine the drug’s effects in a randomized-controlled study of patients. The Solidarity trial is testing four of the most promising Covid-19 treatments in a giant multi-country collaboration.
Now, even before the WHO study was fully underway, research published Saturday in The Lancet found there was a higher mortality rate in COVID-19 patients who received hydroxychloroquine, chloroquine, or a combination of either drug and azithromycin, as compared to COVID-19 patients who did not receive any treatments.
No a final verdict
That is not the final word, however, on hydroxychloroquine, normally used in the treatment of lupus. The Lancet study was an “observational” study of patients who happened to receive the drug. The WHO’s planned “randomized-controlled” study would compare similar groups of patients who do and do not receive the drug - a method that is the gold standard in medical research, as part of the Solidarity Trial is testing four of the most promising Covid-19 treatments.
Even so, the recent findings were clearly worrisome enough to give WHO reason to pause - quite literally.
On Monday, WHO’s Director General Dr Tedros Adhanom Ghebreyesus announced at a press briefing that a group of ten experts overseeing the multi-country trial had announced the “temporary pause” in recruiting patients:
“The group has agreed to review a comprehensive analysis and critical reappraisal of all evidence available globally. The review will consider data collected so far in the Solidarity trial, and important, robust randomized available data to evaluate the potential benefits and harms from this drug.”
Added WHO’s Chief Scientist, Dr Soumya Swaminathan:
“We know that the evidence from observational studies, however large they may be, is still subject to inherent bias. What’s really important is to have well-conducted randomized control studies, done in large numbers.”