Gold standard COVID-19 prevention trial opens

Gold standard COVID-19 prevention trial opens

Illuminate newsletter index page, June 2020
June 2020

Professor Marc Pellegrini
The Institute’s joint head of Infectious Diseases and Immune
Defence Professor Marc Pellegrini is co-leading the
gold standard COVID SHIELD study.

A gold standard, multicentre, randomised, double-blind, placebo-controlled clinical
 trial to determine whether the drug hydroxychloroquine is an effective prevention against COVID-19 is now underway in Australia.

COVID SHIELD will recruit 2250 frontline and allied healthcare professionals over 6-8 months, aiming to protect the Australian healthcare workforce from COVID-19.

In a major collaborative effort led by the Institute in partnership with human data science organisation IQVIA, the trial is being run through Australian hospitals and has been funded through the federal government’s Medical Research Future Fund.

Leading the investigation is Professor Marc Pellegrini, who is joint head of Infectious Diseases and Immune Defence at the Institute, and Professor Ian Wicks, joint head of Clinical Translation at the Institute and Head of Rheumatology at the Royal Melbourne Hospital.

Anti-viral potential

COVID-19 is caused by the newly identified virus SARS-CoV-2. The virus can lead to a progressive respiratory illness requiring ventilatory support and can be fatal.

Hydroxychloroquine is being tested because it has shown promising anti-viral activities, including against SARS-CoV-2, in laboratory studies conducted at the Institute. These findings have been substantiated by research from laboratories around the world.

Professor Pellegrini said hydroxychloroquine had not yet been rigorously trialled in healthy people as a preventative therapy for COVID-19.


“COVID SHIELD is gold standard in its design as a multicentre, randomised, double-blind, placebo-controlled study looking at the effectiveness of hydroxychloroquine as a prophylaxis in healthy people,” he said.

“It is vital not to confuse this with treatment or retrospective studies involving hydroxychloroquine as they are worlds apart.”

Safety first

Professor Wicks said hydroxychloroquine was a well-known prescription medication that had been widely used in rheumatology for more than 
50 years.

“Many thousands of patients in Australia are currently taking hydroxychloroquine as a prescribed treatment for rheumatic conditions.

“Like any medication, hydroxychloroquine has certain side effects, but fortunately these are well known and quite uncommon.

“The medical specialists conducting COVID SHIELD are highly experienced in using hydroxychloroquine and comfortable with its safety profile.

“Participants will be screened based on rigorous criteria and closely monitored to ensure safety."

“Until we get a vaccine, carefully evaluating other protective strategies, particularly existing medications, is clearly important,” he said.

Healthcare workers can register interest on the COVID SHIELD trial website.

 

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