Statement on the Defence chloroquine trial

To be attributed to a department of Defence spokesperson 

The Government is focused on slowing the spread of COVID-19 to save lives and livelihoods.

As part of Defence’s contribution to the Whole-of-Government COVID-19 response, Defence has initiated a voluntary clinical trial of chloroquine as a preventative measure against COVID-19.

It’s important to clarify, this trial is not an anti-malarial trial — this is testing a known drug as a potential preventative measure against COVID-19 to protect our frontline health staff.

The trial is seeking up to 700 civilian and Australian Defence Force (ADF) frontline healthcare workers and will examine whether this drug can prevent COVID-19. Chloroquine is only being trialled as a preventative measure, not as a treatment and not as a vaccine.

The clinical trial will use 500mg tablets of chloroquine phosphate, comprising a 300mg base dose of chloroquine and 200mg of phosphate (salt). Based on this, the dosing regimen of chloroquine for the duration of the trial is a once-off three-day loading dose of 300mg chloroquine base per day, followed by a weekly 300mg chloroquine base dose. The trial will be conducted over several months and its duration will depend on how the pandemic evolves. Defence will not deliberately expose members to COVID-19.

The safety of all those involved in the trial, including our ADF personnel, is our key priority and participation in this trial is entirely voluntary and participation requires a deliberate action by potential volunteers. This requires accessing and reading all online information, watching a video explaining the trial and making an appointment to attend in-person for evaluation.

Volunteers are carefully screened against a set of inclusion and exclusion criteria, which includes assessment of known allergies. During the trial, volunteers will fill out daily questionnaires detailing the current state of their health and wellbeing, which will be closely monitored by the trial scientists and medical experts. Importantly, volunteers can remove themselves from the trial at any time for any reason with no consequences.

The trial is only seeking volunteers who are either civilian or ADF healthcare workers between the ages of 18 and 64. Healthcare workers are knowledgeable and well-practised in receiving and providing informed consent.

Currently there are 42 volunteer ADF healthcare volunteers enrolled and have started the 14 week trial, around three-quarters of which are officers.

There is currently no cure for COVID-19. Australia must be a global participant in attempting to find a cure and prevention measures for those staff on the frontline of this pandemic. Well-conducted clinical trials are needed in the global fight against COVID-19.

ADF capabilities are not immune to the threat of COVID-19, as such there is a need for Defence involvement with this trial. We need to maintain a sovereign capacity to develop such medical countermeasures in the interests of protecting our nation.

This trial is being conducted through the Australian Defence Force (ADF) Malaria and Infectious Diseases Institute, in partnership with the National Medical Countermeasures Initiative at DMTC Ltd. Ethics approval for the trial has been provided by the Departments of Defence and Veterans’ Affairs Human Research Ethics Committee. The clinical trial notification has been filed with the Therapeutic Goods Administration and will be subject to its rules and regulations.