Hydroxychloroquine Halted in WHO-Sponsored Covid-19 Trials

(Bloomberg) -- Tests of hydroxychloroquine, an anti-malaria drug touted by U.S. President Donald Trump, were halted in a World Health Organization trial of potential Covid-19 treatments.

The hydroxychloroquine arm of the WHO’s Solidarity trial was stopped after advisers concluded that the drug shows no benefit compared to the standard of care in reducing deaths, Ana Maria Henao-Restrepo, a WHO medical officer, said Wednesday at a briefing in Geneva.

Trump has touted the antimalarial as a treatment for the coronavirus since the early weeks of the global outbreak, calling it a “game-changer,” but its prospects have faded. U.S. Food and Drug Administration on Monday revoked emergency-use authorization for hydroxychloroquine and chloroquine, a related antimalarial drug, after determining they were unlikely to treat the virus and could have dangerous side effects.

The WHO’s Solidarity trial is one of several worldwide that pits a few drugs against each other to identify those that are most effective against Covid. The tests are designed so that ineffective drugs can be weeded out and promising new ones can be added. The experts are also reviewing interim data about another arm that uses the combination of the drugs lopinavir and ritonavir to decide whether those studies merit continuation, WHO Chief Scientist Soumya Swaminathan said in a briefing Thursday. Abbott Laboratories sells the combination under the brand Kaletra.

She also said more tests are needed to determine whether hydroxychloroquine might be helpful in preventing Covid-19.

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An experiment run by the University of Oxford released data Tuesday showing that the inexpensive, generic steroid dexamethasone improves survival in severely ill Covid patients. The only other drug to show benefit in a robust trial is Gilead Sciences Inc.’s remdesivir, an antiviral.

Controversy has swirled around hydroxychloroquine since Trump began promoting it. The U.S. bought millions of doses, while shortages ensued for patients with lupus, rheumatoid arthritis -- other conditions the drug has been shown to treat -- as well as malaria. There were reports of people taking the drug preventively, and Trump himself said he took a course of the medication to ward off infection after two White House staffers contracted Covid-19 in May.

Various studies have supported and detracted from the drug’s effectiveness against the coronavirus, but until recently, few were designed in a way that
would determine its benefit. On June 5, Oxford researchers released data from a placebo-controlled trial showing that the drug didn’t lower Covid patients’ risk of death.

The decision for the WHO’s trial was made by independent experts and doesn’t constitute a guideline by the agency, Henao-Restrepo said. It also didn’t consider whether hydroxychloroquine could help prevent Covid-19, she said.

The World Health Organization had earlier halted the hydroxychloroquine portion of the trial temporarily after a study of patient records in the Lancet medical journal linked it to deaths and heart risks. The study was retracted after its data source came into question, and the WHO’s research on the drug was restarted.

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