Updated statement on the Defence chloroquine trial
18 May 2020
To be attributed to a Defence spokesperson:
The Government is focused on slowing the spread of COVID-19 to save lives and livelihoods. We all have a part to play.
As part of Defence’s contribution to the Whole-of-Government COVID-19 response, Defence initiated a voluntary clinical trial of chloroquine as a preventative measure against COVID-19.
This trial is not an anti-malarial trial — this is testing a well-known drug as a potential preventative measure against COVID-19 to protect 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. It is not a vaccine.
This chloroquine trial is not an anti-malarial trial. Chloroquine has been used to treat malaria for 70 years and used by over a billion people and the safety profile is well established.
There are a number of import distinctions to make with regard to this voluntary trial:
- It is not an anti-malarial trial.
- It is not a vaccine trial.
- It is not a treatment trial.
- This trial is not open to all ADF members. Volunteers are being sought from ADF frontline healthcare workers.
- This trial is not testing hydroxychloroquine.
- This trial is not deliberately exposing volunteers to COVID-19.
More information on the trial can be found here: https://news.defence.gov.au/media/on-the-record/statement-defence-chloroquine-trial
Defence understands the concerns around the ethics of ADF members volunteering for clinical trials.
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.
A participant advocate will also provide volunteers with a confidential mechanism to provide advice and support – one of the recommendations from the 2018 Senate Inquiry into the use of the Quinoline anti-malarial drugs Mefloquine and Tafenoquine in the ADF.
There is no pressure from Defence, command or anyone else to volunteer for this clinical trial. If someone does feel they have been pressured to join the trial, there are a number of additional avenues available to members, including their chain of command, pastoral services, healthcare providers and the equity and diversity adviser network. Importantly, volunteers can remove themselves from the trial at any time for any reason with no consequences.
Defence is ensuring that ADF members who sign up to this trial are doing so completely voluntarily by specifically 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.
Informed consent involves two parts: (1) individuals exercising their right to determine what happens to their body; and (2) the providers/researchers duty to provide enough information to individuals to make an educated decision whether to participate in the medical intervention/research study or not.
The 2018 Senate Inquiry also noted:
“The committee does not believe that all medical research with members of the ADF should be prohibited, provided it does not disrupt the work of the ADF and has been approved in accordance with the National Statement. This is because research is essential for advancing medical care and force protection measures, and the ADF has a duty of care to protect and maintain the health of its personnel.”
The Senate Inquiry acknowledged that there was no evidence that good clinical practice was not followed; and that the trials were conducted ethically and lawfully and in accordance with the National Guidelines issued by the National Health and Medical Research Council and the Therapeutic Goods Administration.
The safety of all those involved in the trial is our highest priority.
Healthcare workers are knowledgeable and well-practised in receiving and providing informed consent.
Participation in the trial 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.
The trial was carefully considered by the Departments of Defence and Veterans’ Affairs Human Research Ethics Committee (DDVA HREC).
DDVA HREC is an independent body registered with the National Health and Medical Research Council (NHMRC) and is responsible for ethical approval of submitted research proposals. The role of the DDVA HREC is to give full consideration to all issues that are raised in respect to any research proposal placed before it for approval.
The National Statement on Ethical Conduct in Human Research explicitly cites the Defence Forces as an example of dependent or unequal relationships that must be considered.
The DDVA HREC decisions are made in accordance with the National Statement that requires members to consider the issue of unequal relationships. In addition, the DDVA HREC has published guidance for researchers on this issue. Ethics approval for the trial has been provided by the DDVA HREC.
The clinical trial notification has been filed with the Therapeutic Goods Administration and will be subject to its rules and regulations.
Trial enrolment is currently on hold due to the Governments successful intervention and subsequent lack of community transmission. If community transmission increases, enrolment will recommence.
Participants will not be directly exposed to COVID-19, but if they are exposed, contact tracing and the COVID-19 app will be used to track their exposure.
Defence and civilian participants will be potentially exposed to the virus in the normal course of their work as frontline health care professionals. Defence force members live and work within Australian communities. It is also the case that Defence Healthcare workers could be called to support the national healthcare system, as was the case for the Tasmania’s North West Regional Hospital and its private counterpart in Burnie.
Trial participants exposure therefore, while not deliberate, has the possibility to occur due to them providing healthcare to the Australian population, as do their civilian counterparts.
When there is widespread community transmission the chances of exposure of healthcare workers to the virus naturally increases. The 42 ADF personnel already on the trial will continue with the program.
The dosage used in this trial is substantially less than that used for other COVID-19 research trials around the world. This clinical trial uses 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.
Confirmation that chloroquine is effective in prevention will provide frontline healthcare workers an important opportunity to be protected against COVID-19.
Good clinical research is required to test this hypothesis.
Further information on the 2018 Senate Inquiry into the use of the Quinoline anti-malarial drugs Mefloquine and Tafenoquine in the ADF:
Defence was fully supportive of the 2018 Senate Inquiry into the use of the Quinoline anti-malarial drugs Mefloquine and Tafenoquine in the ADF. The Inquiry made 14 recommendations and the Government largely supports the views of the Committee, agreeing to 12 of the Committee’s recommendations and agreed in principle to two the remaining two.
Defence has implemented the recommendations from previous inquiries, including the appointment of a participant advocate to provide a confidential mechanism for volunteers to seek advice and support.
The Senate Inquiry process acknowledged that there was no evidence that good clinical practice was not followed.
The Senate Inquiry also noted the trials were conducted ethically and lawfully and in accordance with the National Guidelines issued by the National Health and Medical Research Council and the Therapeutic Goods Administration.
The Senate Committee recognised that some individuals who have taken mefloquine and tafenoquine are now unwell and have complex health needs, and while it was found their conditions are not attributable to the anti-malarial drugs, they still require support.
The Government has committed $2.1 million to support veterans who are concerned about having taken the anti-malarial drugs mefloquine or tafenoquine.
Veterans who are concerned are encouraged to contact DVA’s dedicated hotline: 1800 MEFLOQUINE (1800 633 567).