Coronavirus: Researchers halt patient recruitment for hydroxychloroquine trial

Australian researchers have halted a major clinical trial of hydroxychloroquine after a new study raised safety concerns.

Hydroxychloroquine is the drug that US President Donald Trump took for two weeks as a preventative against coronavirus. Picture: AFP

Australian researchers have suspended patient recruitment in a major clinical trial of the controversial anti-malaria drug hydroxychloroquine.

The Doherty Institute announced the pause on the ASCOT trial, which was to involve 2000 patients with COVID-19 in Australia and internationally, following the publication of a study in the Lancet which cast doubt on the treatment.

The Lancet study found people taking hydroxychloroquine were at higher risk of death and heart problems, and that there was no benefit to treating coronavirus patients with the drug.

The World Health Organisation suspended a clinical trial of the drug in the wake of the Lancet paper, a large observational study of over 90,000 COVID-19 infected patients from six continents and 671 hospitals. The study showed a lack of efficacy of hydroxychloroquine and an increase of over 35 per cent of serious cardiac side effects.

The Doherty Institute, which is leading the ASCOT trial in more than 70 Australian hospitals, issued a statement on Thursday afternoon announcing the pause on patient recruitment. “Following an observational study published in The Lancet on Friday, 22 May, the AustralaSian COVID-19 Trial (ASCOT) has paused patient recruitment pending deliberations by the governance and ethics committees overseeing the trial,” the statement said. “We expect these deliberations to occur rapidly and will provide further information as they arise.”

The ASCOT trial is one of two randomised control trials testing the efficacy of hydroxychloroquine.

In the trial, a quarter of the patients were to be given hydroxychloroquine and a quarter given the anti-HIV drug lopinavir, also known as ritonavir.

A quarter of patients were to receive a combination of the two drugs, and a quarter given no treatment.

Hydroxychloroquine is the drug that US President Donald Trump took for two weeks as a preventative against coronavirus.

Hydroxychloroquine was also given to Tom Hanks’s wife Rita Wilson in a Queensland hospital. She’s spoken of experiencing “extreme side effects” from the drug, saying the medication left her feeling “completely nauseous” and suffering from vertigo.

“I could not walk and my muscles felt very weak,” Ms Wilson said of her treatment. “I think people have to be very considerate about that drug. We don’t really know if it’s helpful.”

Thousands of people in Australia are taking hydroxychloroquine for rheumatoid arthritis and lupus. The drug is not well-known for extreme side effects, but it is associated with dangerous heart rhythm problems in certain patients.

Scientists from the Walter and Eliza Hall Institute are currently leading a clinical trial involving more than 2,000 health workers in 14 hospitals and health service facilities in Australia. They’re testing whether the drug is effective as a preventative for those at high-risk of contracting COVID-19.

A researcher leading that study, known as COVID-SHIELD, Marc Pelligrini, says scientists are “entirely comfortable” continuing with the trial. The study’s leaders have considered the Lancet paper carefully, and are screening participants thoroughly.

“The comments that the authors of the Lancet paper made was that their results being observational results shouldn’t be over-interpreted, or applied to proper clinical controlled studies.

“They made a distinction between using hydroxychloroquine in people who are very sick, versus those that were not admitted to hospital or who were well. So the extension being that, if you’re giving it to people who well, their trial had no real implications for those studies.”

The ASCOT Trial’s leaders are also urging caution in the interpretation of the Lancet study. They stress it is not a randomised control trial and suffers from bias, in that many of the participants involved in the study had a higher baseline risk of death.

They point out that a major clinical trial of hydroxychloroquine known, as the Recovery trial, is proceeding in the UK even in the wake of the Lancet report.

That trial’s data safety monitoring board did an interim analysis of the clinical trial and find no concerning safety signals in 10,000 patients.

The Doherty Institute says the decision of the ASCOT Trial’s governance and ethics committees as to whether to continue giving hydroxychloroquine as part of the trial are expected imminently. “We expect these deliberations to occur rapidly and will provide further information as they arise,” the Doherty Institute said.

The ASCOT Trial is an adaptive study, so if hydroxychloroquine was discontinued as part of the study on safety grounds, the trial of the other drugs may continue.