LONDON (Reuters) – A global trial designed to test whether hydroxychloroquine and chloroquine anti-malaria drugs can prevent COVID-19 infection needs to be restarted after it has been approved by British regulators.
FILE PHOTO: a pharmacist shows a box of hydroxychloroquine at the CHR Center Hospitalier Regional de la Citadelle Hospital between coronavirus disease (COVID-19) in Liege, 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 process after hydroxychloroquine was found in another British study for not having any benefit as a treatment for patients already infected with COVID-19, the disease caused by the new coronavirus.
The COPCOV study was paused pending review after the results of the therapeutic trial.
This is a randomized, placebo-controlled study that aims to enroll 40,000 health professionals and other at-risk personnel worldwide and is led by the Mahidol Oxford Tropical Medicine Research Unit of the University of Oxford (MORU) in the capital Thai, Bangkok.
U.S. President Donald Trump said in March that hydroxychloroquine could change the game and then said he was taking it on his own, even after the U.S. regulator, the Food and Drug Administration (FDA), informed that the its effectiveness and safety had not been proven.
The FDA subsequently revoked authorization for emergency use for drugs to treat COVID-19, after studies showed that they were not useful as treatments.
But Professor Nicholas White of the University of Oxford, who leads the COPCOV study, said studies of drugs as a potential preventive medicine have not yet given a definitive answer.
“Hydroxychloroquine could still prevent infections, and this needs to be determined in a randomized controlled trial,” he said in a statement. “The question of whether or not it can prevent COVID-19 remains as relevant as ever.”
White’s team said recruiting British health workers will resume this week and plans are underway for new sites in Thailand and Southeast Asia, Africa and South America. Results are expected later this year.
The death toll of COVID-19 surpassed half a million people on Sunday, according to a Reuters count, with the number of cases reported globally now more than 10 million.
Reporting by Kate Kelland, editing by Paul Sandle and Timothy Heritage