- Treatment with the malaria pill hydroxychloroquine didn't help patients hospitalized with COVID-19 survive or recover faster any more than standard treatment, according to investigators testing several coronavirus disease drugs in a large, controlled study involving thousands of people in the U.K.
- The trial, dubbed RECOVERY, has been closely watched and its preliminary findings on hydroxychloroquine are one of the most significant signs yet that the decades-old drug has little benefit to offer patients already sick with COVID-19.
- Full results aren't yet available, but the investigators' conclusion was unequivocal: "These data convincingly rule out any meaningful mortality benefit of hydroxychloroquine in patients hospitalized with COVID-19," said study investigators Peter Horby and Martin Landray, both of whom are professors at the University of Oxford, which led the trial.
Results from RECOVERY appear to offer further support for an emerging scientific consensus that hydroxychloroquine likely doesn't work, or work very well, in treating COVID-19.
Just two days ago, a University of Minnesota trial found the drug did not help prevent people exposed to the new coronavirus from getting sick. The findings were the first to emerge from a large, randomized and placebo-controlled study — an approach considered by scientists to be the most definitive way to assess whether a treatment works.
With RECOVERY now showing no benefit to hydroxychloroquine in already sick, hospitalized patients, the case for the pill has weakened substantially. RECOVERY was also randomized and controlled.
Friday's disclosure resulted from a review by the trial's independent data monitoring committee, which was requested by the U.K. drugs regulator. The panel then recommended study investigators assess the data.
Just over 1,500 patients hospitalized with COVID-19 were given hydroxychloroquine through the study, and were compared to 3,132 people who received standard treatment. After 28 days — the trial's primary endpoint — 25.7% of hydroxychloroquine-treated patients had died, compared to 23.5% of those who received usual care. Both those mortality rates are high, surpassing rates observed in other studies of hospitalized COVID-19 patients.
Hydroxychloroquine also did not show any benefit in reducing patients' time in hospital, the investigators said.
Enrollment of patients to receive the drug was immediately stopped as a result of the findings.
"There has been huge speculation and uncertainty about the role of hydroxychloroquine as a treatment for COVID-19, but an absence of reliable information from large randomized trials," said Oxford's Landray in a statement.
"This result should change medical practice worldwide," he added.
The investigators' conclusions, however, have not been published, released instead via press release. And they arrive at a time when hydroxychloroquine research has been put under intense scrutiny.
The medical journal The Lancet this week retracted an analysis of hydroxychloroquine use in hospitalized patients that found no evidence of benefit. Data used to conduct the retrospective analysis was drawn from records at 671 hospitals around the world, extracted by an analytics company called Surgisphere.
But since the article was published, other researchers found gaps and errors in Surgisphere's data. The company refused to participate in an audit sought by three of the study's authors, prompting the high-profile and damaging retraction.
Use of hydroxychloroquine has also become politically charged in the U.S., after President Donald Trump repeatedly promoted the drug and later said he had taken it for two weeks.
The Food and Drug Administration granted an emergency authorization for its use, allowing federal stockpiles to disburse donated supplies widely across the country. Data shows prescriptions of the drug spiked, but have since fallen off.
RECOVERY is one of several large international studies of hydroxychloroquine, including a trial in France and one run by the World Health Organization.
More than 11,000 patients were enrolled through 175 National Health Service hospitals in the U.K. and randomized to receive one of six experimental COVID-19 treatments, or usual care. Apart from hydroxychloroquine, researchers are also studying a drug approved to treat HIV, the antibiotic azithromycin, a common steroid, an anti-inflammatory treatment for arthritis and convalescent plasma.