WHO drops hydroxychloroquine from Covid-19 clinical trial

The World Health Organization on Wednesday said it was dropping the malaria medicine hydroxychloroquine from its massive study investigating treatments for the coronavirus, after available data indicated the drug was not effective for Covid-19.

The announcement from the agency is the latest blow to the hopes that hydroxychloroquine, as well as the related drug chloroquine, could provide patients an option at a time when there are too few treatments available for the virus. Those hopes were fanned by President Trump and some of his political allies, who vowed the drug could be a game changer despite a dearth of evidence indicating they worked.

But in recent weeks, rigorous studies have found that hydroxychloroquine did not show benefits for patients with Covid-19 and did not prevent people who had been exposed to the virus from becoming sick.

At a WHO briefing, Ana Maria Henao Restrepo, who leads the agency’s research and development blueprint, said the decision to halt the hydroxychloroquine portion of the multiarm Solidarity trial came as a result of the failure of the drug in the other study looking at it as a treatment, and of the data generated so far in the Solidarity trial. The studies showed hydroxychloroquine did not reduce mortality in Covid-19 compared to standard of care.

“The decision was made to stop the randomization with the hydroxychloroquine trial,” Henao Restrepo said.

Patients who were already enrolled and were in the midst of their hydroxychloroquine regimen can complete their course or stop, the WHO said.

The Solidarity trial is continuing to compare other potential Covid-19 drugs. More than 400 hospitals in 35 countries are participating in the study.

Earlier this week, the Food and Drug Administration revoked its emergency authorization for hydroxychloroquine and chloroquine for Covid-19 after determining the drugs “are unlikely to be effective” in treating the disease. It also said that there had been reports of “serious cardiac adverse events and other serious side effects” associated with using the drugs in Covid-19.

In addition to malaria, the two drugs are shown to be safe and effective for rheumatoid arthritis and lupus.

WHO officials also said Wednesday they were awaiting the full data from another study this week that, the investigators said, found that a steroid called dexamethasone reduced deaths in patients with severe Covid-19 illnesses (those sick enough to require oxygen or be placed on ventilators). They said they were also analyzing data from other studies of steroids in Covid-19, which could lead to new clinical guidance for treating patients.

Mike Ryan, the head of the agency’s emergency program, praised the potential of dexamethasone, but stressed that it needed to be used under medical supervision and was meant only for patients in serious condition.