COVID SHIELD is a major collaborative effort led by the Walter and Eliza Hall Institute in partnership with human data science company IQVIA and healthcare providers across Australia, which began in May 2020.

The trial will assess whether the drug hydroxychloroquine is useful in preventing COVID-19 disease, caused by SARS-CoV-2 infection, in frontline and allied healthcare workers.

This group is at increased risk of infection due to repeated exposure caring for COVID-19 patients.

The trial will enrol healthcare workers through participating hospitals. Half the participants will be given hydroxychloroquine, and the other half will receive a placebo tablet. Individual participants will receive doses of hydroxychloroquine or the placebo control for a maximum of four months. Results from the trial are expected in late-2021.

At the time of trial commencement, more than 10 per cent of COVID-19 cases in Australia had occurred in health care workers. These health care workers are often at higher risk of infection due to their contact with moderately to critically ill COVID-19 patients and may be exposed on a recurring basis. As such, it is important to find suitable approaches to protecting these at-risk people from COVID-19.

Why are you conducting a clinical trial using hydroxychloroquine?

Hydroxychloroquine has been identified as having potential antiviral activity against SARS-CoV-2 in preclinical (laboratory-based) research conducted at the Institute and substantiated by research that has been replicated by other laboratories around the world.

The COVID SHIELD trial is exclusively looking at hydroxychloroquine as a preventative therapy for COVID-19. The trial is not using the drug in people who have tested positive for COVID-19 or as a treatment for people who are sick with COVID-19.

There are several examples of drugs that are effective in preventing diseases but less effective in treating them, such as antiretroviral drugs used for pre-exposure prophylaxis (PrEP) to HIV and neuraminidase inhibitor drugs (oseltamivir (Tamiflu®) and zanamivir (Relenza®)) used for influenza.

Hydroxychloroquine has been in clinical use for decades and is currently being taken by thousands of Australians for rheumatic conditions. Like any medication, hydroxychloroquine has certain side effects, but fortunately these are well known and quite uncommon.

When will we have results of the COVID SHIELD trial?

The COVID SHIELD trial recruited its final participants at the end of October 2020. We are expecting results of this study in late-2021, subject to the analysis of all the data. We are harmonising our data with similar trials internationally, to allow data sharing and complementary analyses of results.

Who is funding COVID SHIELD?

Funding for the trial has come from the Australian Government through the Medical Research Future Fund (MRFF) after independent, expert peer review that was overseen by the National Health and Medical Research Council (NHMRC). The Walter and Eliza Hall Institute is providing some direct financial support to the trial, including through direct community fundraising activities. The trial is not currently funded by any other government, private or industry sources.

Who approved the COVID SHIELD trial?

COVID SHIELD is a multi-centre trial that has been reviewed and approved by an independent NHMRC Human Research Ethics Committee (HREC) accredited to perform single ethical review of multi-centre research. The Walter and Eliza Hall Institute and and each participating hospital’s HREC and or Research Governance Office have similarly reviewed the project. COVID SHIELD conforms to the NHMRC Statement on Ethical Conduct in Human Research.

COVID SHIELD has been independently peer-reviewed and endorsed by the Australasian Society of Infectious Diseases and MRFF, and further endorsed by the Melbourne Academic Centre for Health, an NHMRC-recognised Advanced Health Research and Translation Centre.

Is the trial registered?

The clinical trial is registered with Australian and New Zealand Clinical Trial Registry and the World Health Organization International Clinical Trials Registry Platform.

Is hydroxychloroquine safe?

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

More than 20 internationally recognised clinical trialists have been involved with the development and implementation of this study. Many of the clinical trialists have been using hydroxychloroquine in patients for more than 20 years and they understand the drug and its side effects.

Will zinc be used in the trial?

Hydroxychloroquine is not being tested with a zinc supplement in the COVID SHIELD trial.

Can I have details of the clinical trial protocols?

We are unable to share the research protocol to ensure that research integrity is maintained and to protect participants. The formal review process is designed to ensure research integrity, safety, confidentiality, equipoise, rationale and scientific merit. We have welcomed this scrutiny by highly qualified, internationally recognised experts and accredited reviewers during the trial development and approval phase.

For further information

• National Health and Medical Research Council: Research Integrity
• Australian Government Medical Research Future Fund
• The regulatory process for clinical trials in Australia (Clinical Trials Australia)