The World Health Organization will resume clinical trials of an anti-malaria drug researchers hope may treat Covid-19, after a study of the drug published in May by a major medical journal prompted them to halt trials due to safety concerns.
The Data Safety Monitoring Board decided there was no reason to discontinue the international trial after reviewing available data on the drug, WHO Director-General Tedros Adhanom Ghebreyesus said during a press conference Wednesday at the agency’s Geneva headquarters.
“The executive group received this recommendation and endorsed the continuation of all arms of solidarity trial including hydroxychloroquine,” he said.
On May 25, WHO announced it had temporarily suspended its trial of the drug over safety concerns. The announcement came days after a study published in medical journal The Lancet found that hospitalized Covid-19 patients treated with hydroxychloroquine had a higher risk of death than those who didn’t take it. That study is now being reexamined.
The suspension spurred French drugmaker Sanofi and others to temporarily halt recruitment for their own trials looking at the drug.
There’s no evidence that any drug actually reduces the mortality in patients who have Covid-19, WHO officials said Wednesday.
Tedros said the safety board will continue to closely monitor the safety of all therapeutics being tested in its trials, which involve more than 3,500 patients across 35 countries.
“WHO is committed to accelerating the development of effective therapeutics, vaccines and diagnostics as part of our commitment to serving the world with science, solutions and solidarity,” he said.
In addition to malaria, hydroxychloroquine is often used by doctors to treat rheumatoid arthritis and lupus. It is known to have serious side effects, including muscle weakness and heart arrhythmia. Numerous clinical trials are looking to see if it’s effective in fighting Covid-19, but it is not a proven treatment.
A week ago, WHO said there was no evidence that the drug is actually effective against the coronavirus.
“We do not advise the use of hydroxychloroquine or chloroquine for the treatment of Covid-19 outside randomized control trials or under appropriate close clinical supervision subject to whatever national regulatory authorities have decided,” Dr. Mike Ryan, executive director of the WHO’s emergencies program, said on May 27.
Trump disclosed last month he was taking hydroxychloroquine daily to prevent infection from the coronavirus. White House physician Dr. Sean Conley released a memo that said that after discussing evidence for and against hydroxychloroquine with Trump, they concluded “the potential benefit from treatment outweighed the relative risks.”
The U.S. Food and Drug Administration has warned patients against taking chloroquine or hydroxychloroquine to treat Covid-19 outside a hospital or formal clinical trial setting. The agency said it became aware of reports of “serious heart rhythm problems” in patients with the virus who were treated with the drugs.
