Trial to determine effectiveness of COVID-19 prevention measure
A clinical trial has commenced to test the effectiveness of a low-dose regimen of the anti-malarial drug Chloroquine to prevent coronavirus illness.
The clinical trial is being funded by Defence and managed by the national Medical Countermeasures Initiative led by DMTC Limited. Experts with experience in clinical trials from DMTC are working alongside personnel at the trial site, the ADF Malaria and Infectious Diseases Institute.
The trial will focus on military healthcare and civilian healthcare workers at the frontline of the national response to COVID-19.
Chloroquine is a well-known drug that is already used around the world for the prevention and treatment of malaria as well as the treatment of some inflammatory and connective tissue diseases.
DMTC CEO Dr Mark Hodge urged caution in the race to provide answers to combating COVID-19.
“Clinical trials are essential to establish global benchmarks and ultimately to prove whether this drug, at these prescribed dose amounts, can prevent infection,” Dr Hodge said.
“Novel medications can take a long time to get through all the tests and approvals that are needed to confirm safety, quality and effectiveness. Re-purposing of an existing drug with a known safety profile has potential benefits in regard to expediting conclusive results.”
Because its safety profile is well understood, the trial can be undertaken rapidly to the high standards required by Australian and international pharmaceutical regulators.
While there is a significant amount of anecdotal evidence to suggest that Chloroquine may be effective against coronavirus, this trial is essential to establish global protocols for effective levels and frequency of dosing.
Chloroquine is currently approved by Australia’s Therapeutic Goods Administration for use as a treatment for malaria, lupus and arthritis, but not currently approved as a prevention or treatment for COVID-19. The DMTC trial has received necessary ethics approvals and is registered with the TGA.
In conjunction with ADFMIDI, the DMTC team is working with international partners to ensure the clinical trial is complementary to other clinical trials of related or different drug treatments being undertaken across the globe.
The Australian Trial is a multi-site, randomised and controlled study that will be based on a dosing level five times lower than that prescribed to over a billion people worldwide for the treatment of malaria. This is also far lower than the dosage used in other trials globally.
Who can be involved?
The trial will involve up to 700 volunteer participants, each for a period of 14 weeks.
Participants in this trial must be between 18 and 64 years of age. The trial’s focus is on military or civilian healthcare workers who are at risk due to high levels of contact with persons thought likely to be infected with respiratory viruses.
Trial participation is voluntary and subject to the provision of informed consent. This trial has adopted a number of Defence practices including the appointment of a patient advocate.
Participants will be screened before admittance to the trial against set criteria including good general health, current and historic use of this or other medications and exposure to COVID-19.