WEHI

COVID-19 prevention trial opens for high-risk healthcare workers

Embargoed until: Publicly released:
Peer-reviewed: This work was reviewed and scrutinised by relevant independent experts.

Randomised controlled trial: Subjects are randomly assigned to a test group, which receives the treatment, or a control group, which commonly receives a placebo. In 'blind' trials, participants do not know which group they are in; in ‘double blind’ trials, the experimenters do not know either. Blinding trials helps removes bias.

People: This is a study based on research using people.

The first gold standard Australian clinical trial to determine whether the drug hydroxychloroquine can prevent COVID-19 is now open. The study, called COVID SHIELD, is recruiting frontline and allied health care professionals, aiming to reduce the incidence of COVID-19 in the Australian healthcare workforce.

Organisation/s: Walter and Eliza Hall Institute of Medical Research (WEHI)

Funder: The Australian Government

Media release

From: Walter and Eliza Hall Institute of Medical Research (WEHI)

The first gold standard Australian clinical trial to determine whether the drug hydroxychloroquine can prevent COVID-19 is now open.

The study, called COVID SHIELD, is recruiting frontline and allied health care professionals, aiming to reduce the incidence of COVID-19 in the Australian healthcare workforce.

COVID SHIELD is a major collaborative effort led by the Walter and Eliza Hall Institute of Medical Research in partnership with human data science company IQVIA. The trial is being run through hospitals across the country, including in Victoria, New South Wales, South Australia and the Australian Capital Territory.

The trial’s lead investigators are the Institute’s joint head of Infectious Diseases and Immune Defence Professor Marc Pellegrini, and Professor Ian Wicks who is joint head of Clinical Translation at the Institute and a rheumatologist at the Royal Melbourne Hospital.

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

Professor Pellegrini said that in addition to searching for vaccines and treatments, it was important to explore preventative medicines to combat the COVID-19 pandemic.

“COVID SHIELD is gold standard in its design as a multi-centre, randomised, double-blind study,” he said.

“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. Our aim is to help people stay safe, well and able to continue in their vital roles.”

The trial will enrol 2250 participants through participating hospitals and healthcare providers. Half of the participants will be given hydroxychloroquine, while the other half will receive a placebo tablet – both for the duration of four months.

Professor Wicks said hydroxychloroquine was a well-known prescription medication that had been used for more than 50 years, initially for malaria and subsequently for autoimmune diseases, such as lupus and rheumatoid arthritis.

“Rheumatologists are very comfortable with the drug’s safety profile. 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 in the clinic. All participants will be screened based on rigorous selection criteria and closely monitored throughout the trial to ensure safety,” he said.

Professor Wicks said there were other trials underway assessing the drug’s activity as a treatment, but that COVID SHIELD was the first to test the drug as a prophylaxis (prevention) against contracting COVID-19.

“We are hopeful this Australian trial will provide a definitive answer to this question. Hydroxychloroquine has shown promising anti-viral activities, including against SARS-CoV-2, and so this is what we will be exploring further,” he said.

Professor Pellegrini said the hydroxychloroquine to be used in the study had been supplied by the manufacturer for that purpose and therefore would not impact patients who routinely required 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 in the trial can visit www.covidshieldtrial.com.au to see if they are eligible for the study.

The research is supported by the Australian Government.

PRESS CONFERENCE 10.00 AM WED 20 MAY 2020 AEST

Location: The Royal Melbourne Hospital, 300 Grattan Street, Parkville, Melbourne
Date: Wednesday 20 May 2020
Time: 
9:45am: Media meet at Royal Melbourne Hospital main reception to be taken to conference location
10.00am: Press conference starts

Announcement and interviews with lead investigators:

  • Professor Marc Pellegrini, Joint Head of Infectious Diseases and Immune Defence, Walter and Eliza Hall Institute
  • Professor Ian Wicks, Joint Head of Clinical Translation, Walter and Eliza Hall Institute, and Rheumatologist, Royal Melbourne Hospital Vision

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  • Walter and Eliza Hall Institute of Medical Research (WEHI)
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