LONDON (Reuters) – A global trial designed to test whether antimalarial drugs hydroxychloroquine and chloroquine can prevent COVID-19 infection, will restart after being approved by British regulators.
FILE PHOTO: A pharmacist shows a box of hydroxychloroquine at CHR Center Hospitalier Regional de la Citadelle amid coronavirus disease (COVID-19) in Liège, Belgium, June 16, 2020. REUTERS / Yves Herman
The Medicines and Health Products Regulatory Agency (MHRA) made its decision on what is known as the COPCOV trial after it was discovered that hydroxychloroquine in another British trial had no benefit as a treatment for patients already infected with COVID-19, the disease caused by the new coronavirus.
The COPCOV study was stopped pending review after the results of the treatment trial.
This is a randomized, placebo-controlled trial that aims to enroll 40,000 health workers and other at-risk personnel worldwide, and is led by the Mahidol Oxford Tropical Medicine Research Unit at the University of Oxford (MORU) in the Thai capital Bangkok.
United States President Donald Trump said in March that hydroxychloroquine could change the rules of the game and then said he was taking it himself, even after the United States regulator, the Food and Drug Administration ( FDA), report that its efficacy and safety have not been proven.
The FDA later revoked the emergency use authorization for drugs to treat COVID-19, after trials showed that they were not beneficial as treatments.
But Professor Nicholas White of Oxford University, who is co-leader of the COPCOV trial, said studies of the drugs as a possible preventive medicine had not yet given a conclusive answer.
“Hydroxychloroquine could still prevent infections, and this must be determined in a randomized controlled trial,” it said in a statement. “The question of whether (it can) prevent COVID-19 or not remains as relevant as ever.”
White’s team said recruitment of British health workers would resume this week, and said plans were being made for new sites in Thailand and Southeast Asia, Africa and South America. Results are expected later this year.
The death toll from COVID-19 exceeded half a million people on Sunday, according to a Reuters count, with the number of reported cases worldwide now more than 10 million.
Reports from Kate Kelland, Paul Sandle and Timothy Heritage edition