Coronavirus: Hydroxychloroquine back on test table after data doubt

Researchers leading a trial testing the efficacy of anti-malarial drug hydroxychloroquine will proceed with administering it to Australian coronavirus patients.

The World Health Organisation has announced that clinical trials of the drug hydroxychloroquine will resume as it searches for potential coronavirus treatments. Picture: AFP

Researchers leading a clinical trial testing the efficacy of anti-­malarial drug hydroxychloroquine will proceed with admin­istering it to Australian corona­virus patients after international studies challenging the drug’s efficacy and safety were questioned.

The Doherty Institute confirmed on Thursday that researchers would resume administering hydroxychloroquine to corona­virus patients in Australia, as the World Health Organisation also moved to restart its own clinical trial of the drug.

The resumption of trials followed revelations that data relied on by scientific journals The Lancet and the New Eng­land Journal of Medicine was based on flawed data from a little-known US healthcare analytics company.

The Guardian reported that employees of the company, ­Surgisphere, included a science-fiction writer and adult-content model.

The Lancet released an “expression of concern” about a large observational study into hydroxychloroquine it published last month, purportedly of 90,000 COVID-19 patients from around the world. The study concluded hydroxychloroquine lacked efficacy, and was associated with an increase of over 35 per cent of serious cardiac side effects.

The Lancet commissioned an audit of the validity of the data, much of which was supplied by Surgisphere, because of “concerns that have been raised about the ­reliability of the database”.

In Australia, the Doherty Institute-led study, the ASCOT trial, was due to enrol more than 2000 COVID-19 patients. One-quarter of the patients were to be given hydroxychloroquine, currently used to treat rheumatoid arthritis and lupus, and recently taken by US President Donald Trump as a preventive. A quarter of patients were to be given anti-HIV drug lopin­avir, also known as ritonavir.

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

The Doherty Institute said the governance committee of the ASCOT trial had unanimously agreed the hydroxychloroquine arms of the study should proceed.

ASCOT principal investigator Steven Tong, a Royal Melbourne Hospital infectious diseases clinician and co-lead of clinical research at the Doherty Institute, said he and the other investigators on the trial were “extremely pleased” with the decision.

“The trial steering committee for ASCOT strongly supports the ongoing need for data from randomised clinical trials … to clarify the efficacy and safety of hydroxychloroquine in patients hospitalised with COVID-19,” Associate Professor Tong said.

“In light of the inherent limitations of observational data, we welcome the … decision to allow us to continue to randomise participants to arms containing hydroxychloroquine.

“Randomised controlled trials are … the ‘gold standard’ when it comes to testing treatments in humans as they remove any bias, providing the robust evidence required to make safe and informed decisions about the ongoing use of a treatment.

“ASCOT is also an adaptive trial … we are able to stop the trial if one of the treatments gives us enough evidence that it will work, or drop any treatment that looks like it will not work before the trial would typically finish.”