WHO hits ‘pause’ on trial

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The international health organisation has temporarily suspended the hydroxychloroquine arm within its COVID-19 treatment trial in light of recent findings

World Health Organization director-general Tedros Adhanom Ghebreyesus has confirmed the organisation has temporarily paused the hydroxychloroquine arm within its SOLIDARITY trial while the safety data is reviewed.

The decision to review the data follows a large observational study recently published in The Lancet which linked hydroxychloroquine and chloroquine use to increased rates of mortality and heart arrhythmias in hospitalised COVID-19 patients.

However Dr Tedros confirmed that the three other arms of the trial will be continuing, including treatment with remdesivir, lopinavir/ritonavir, and lopinavir/ritonavir with interferon beta-1a.

Dr Tedros emphasised that the concern relates specifically to the use of hydroxychloroquine and chloroquine in COVID-19 patients.

“I wish to reiterate that these drugs are accepted as generally safe for use in patients with autoimmune disease or malaria,” he said.

“WHO will provide further updates as we know more.”

In light of the recent study findings, the AustralaSian COVID-19 Trial (ASCOT) is also reportedly under review.

A spokeswoman for the trial told Guardian Australia that the governance committee would meet on Tuesday to discuss the implications of the Lancet study and the WHO statement on the future of the trial.

Meanwhile the Department of Health is changing its advice regarding use of the drug.

The Department of Health had previously said the drugs may be given “in a clinical trial setting or in a controlled environment in the treatment of severely ill patients in hospital.”

On Tuesday a health department spokesperson told AJP this would now change.

“The Department will be updating its advice that hydroxychloroquine use in treating COVID-19 is strongly discouraged including in hospitalised patients unless the patient is enrolled in a clinical trial, noting that currently numbers hospitalised in Australia are very low, at this stage only 30, and there are fewer than 500 active cases across Australia,” said a spokesperson from the TGA.

Meanwhile the Australian COVID-SHIELD clinical trial on hydroxychloroquine treatment for the virus is reportedly still continuing.

Lead investigator Professor Ian Wicks told newsGP that “All participants are going to be carefully screened for any cardiac problems that might predispose them to cardiotoxicity … [so] we’ll be monitoring for that, along with any new symptoms.

“We would certainly agree with all the caution that has been articulated around using this outside of a properly conducted clinical trial,” said Professor Wicks.

The research team is hopeful that COVID-SHIELD will be a ‘gold standard’ randomised controlled trial of the potential use of hydroxychloroquine as a prophylactic.

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  1. John Wilks

    Commenting on the Lancet study by Mehra et al, Dr Josh Davis of the Doherty Institute and principal investigator of the ASCOT (hydroxychloroquine) study planned by the Institute noted that patients in the Lancet paper who received hydroxychloroquine (HCQ) “ … had a higher risk of death at baseline than those who didn’t. They were sicker and they had more comorbidities. That alone could potentially explain the higher risk of death. The only way of knowing whether that’s true or not is to do a randomised trial.” (The Australian).

    In short, giving a drug like HCQ to patients with cardiovascular problems (AF, IHD etc) then also adding in a cardiotoxic macrolide, thereby further increasing the risk of torsades de pointe and downstream arrhythmia’s, can only have a bad outcome. And this is what the Lancet study showed. Give sick patients a dangerous drug combination, and they die more frequently than the control group, who didn’t receive said drugs.

    Commenting of the BMJ study by Mahevas et al. Brian J Lipworth, Professor of Pulmonology (Scottish Centre for Respiratory Research, Ninewells Hospital and Medical School) noted that 85% of patients in this study who were given HCQ had evidence of the cytokine storm, because their C-reactive protein (CRP) levels were giving greater than 40mg/L on admission. A CRP higher than 42mg/l on admission is predictive of a poor outcome.

    Hence, there was no clinical merit in treating 85% of these patients with HCQ – they were already in the storm phase. The putative mechanisms of action of HCQ only include interference with viral binding to the ACE2 pulmonary receptor, thus reduce viral-cell membrane fusion, and an increase intracellular pH, thereby reducing viral replication.

    Hence the secret to hydroxychloroquine (HCQ) success might reasonably be found in the use of zinc with HCQ, as has been recently demonstrated by Carlucci and co-workers at 4 New York Hospitals.

    BUT, HCQ has no place in the treatment of severe COVID-19 patients, particularly when the cytokine storm begins, and interleukin-6 (IL-6) and CRP are higher than their usual level.

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