PARIS / LONDON / MILAN (Reuters) – EU governments on Wednesday moved to stop the use of anti-malaria drug hydroxychloroquine to treat COVID-19 patients, and a second global trial was suspended. Donald Trump.
The move from France, Italy and Belgium followed a decision by the World Health Organization on Monday to pause a major trial of hydroxychloroquine due to safety concerns.
A British regulator said on Wednesday that a separate trial had also been held, less than a week after it began. The study, led by the University of Oxford and partly funded by the Bill and Melinda Gates Foundation, was expected to involve as many as 40,000 healthcare workers.
“All hydroxychloroquine trials in COVID-1
The rapid movements of authorities in countries most affected by the pandemic highlighted the challenge for governments’ distortion to find ways to treat patients and control the new coronavirus.
After early reports that it might help some patients, regulators in several countries had allowed hydroxychloroquine to be used as a potential COVID-19 treatment.
Trump was a particularly strong supporter and described the drug as a “game developer.” He later announced that he was taking it to prevent infection.
Recent studies, however, have raised serious security problems. The British medical journal The Lancet has reported that patients with coronavirus receiving hydroxychloroquine were more likely to die and experience dangerous irregular heartbeats.
On Wednesday, the French Ministry of Health canceled a decree in place for nearly two months that had allowed hospital doctors to distribute it in specific situations for COVID-19.
Drug authorities in France and Italy said that the drug should not be used for COVID-19 outside clinical trials. The Belgian regulator said that trials aimed at evaluating the drug should also take into account potential risks.
Swiss pharmaceutical manufacturer Novartis continues its US study with 440 patients, while French company Sanofi refused to comment on the future of its two studies.
The Italian health authorities concluded that the risks, together with some evidence that hydroxychloroquine was beneficial to COVID-19, deserved a ban outside clinical trials.
“New clinical evidence for the use of hydroxychloroquine in people with SARS-CoV-2 infection … indicates an increased risk of side effects with little or no benefit,” said the AIFA.
The WHO said a safety panel would evaluate the drug’s use in mid-June in its multi-country study of potential COVID-19 treatments.
Germany is looking at The Lancet study and WHO’s decision but has made no decision on new guidance on hydroxychloroquine, says a spokeswoman for its drug regulator.
U.S. The Food and Drug Administration has allowed health care providers to use hydroxychloroquine for COVID-19 through an emergency use permit, but has not approved them to treat it. In April, it also warned that for safety reasons, the drug would only be used for patients with COVID-19 in hospitals or in clinical trials.
The Agency did not respond to questions asking about the reconsidered emergency use authorization.
Reporting by Matthias Blamont in Paris, Emilio Parodi in Milan, Marine Strauss in Brussels, Ludwig Burger in Frankfurt, Alistair Smout in London and Michael Erman in New York; Writing by Josephine Mason and John Miller; Editing by Mark Heinrich / Peter Graff and Grant McCool