COVID-19 prevention trial opens for healthcare workers
US President Donald Trump has made no secret of his affection for the antimalarial drug hydroxychloroquine, touting it as a “game changer” in the fight to treat COVID-19 and recently revealing that he has begun taking the drug himself as a preventative measure against the disease. But while the President’s actions have been criticised given his lack of medical background, Australian researchers are now putting hydroxychloroquine’s apparent preventative abilities to the test in a new clinical trial — and the nation’s healthcare workers are invited to take part.
The COVID SHIELD Trial is a major collaborative effort led by the Walter and Eliza Hall Institute of Medical Research (WEHI) in partnership with human data science company IQVIA and healthcare providers across the country, including in Victoria, NSW, South Australia and the ACT. Its lead investigators are Professor Marc Pellegrini, WEHI’s joint head of Infectious Diseases and Immune Defence, and rheumatologist Professor Ian Wicks, WEHI’s joint head of Clinical Translation.
Caused by the newly identified coronavirus SARS-Cov-2, COVID-19 can lead to a severe and progressive respiratory illness requiring ventilatory support. It is therefore important that preventative medicines are explored to help combat this new disease — and while there are other trials underway assessing hydroxychloroquine’s activity as a treatment, Prof Wicks said COVID SHIELD is the first to test the drug as a prophylaxis, or prevention, against contracting COVID-19.
“Hydroxychloroquine has shown promising antiviral activities, including against SARS-CoV-2, and so this is what we will be exploring further,” he said.
Prof Pellegrini described COVID SHIELD as “gold standard in its design as a multicentre, randomised, double-blind study”. The trial will enrol 2250 participants through participating hospitals, half of whom will be given hydroxychloroquine while the other half will receive a placebo tablet over the four-month trial period.
“The trial is focused on our frontline and allied healthcare workers who are at an increased risk of infection due to repeated exposure caring for sick patients,” Prof Pellegrini said. “Our aim is to help these people stay safe, well and able to continue in their vital roles.”
Prof Wicks said hydroxychloroquine is a well-known prescription medication that has been used for more than 50 years, initially for malaria and subsequently for autoimmune diseases such as lupus and rheumatoid arthritis. And while he acknowledged that it has certain side effects — some more severe than others — he said these are “well known and quite uncommon” and that “rheumatologists are very comfortable with the drug’s safety profile”.
“All participants will be screened based on rigorous selection criteria and closely monitored throughout the trial to ensure safety,” he said.
Prof Pellegrini added the hydroxychloroquine to be used in the study has been supplied by the manufacturer for that purpose and therefore will not impact patients who routinely require the drug for other conditions.
“COVID SHIELD will not be diverting hydroxychloroquine for routine use from pharmacies, hospitals or other patient supply chains,” he said.
Frontline and allied healthcare workers who wish to participate can visit the trial website — www.covidshieldtrial.com.au — to check details on inclusion and exclusion criteria to see if they can proceed to be screened for the study.
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