Coronavirus patients at hospitals around the country, including Canberra, will be given the chance to receive two potential treatment drugs - HIV drug Kaletra and hydroxychloroquine - in a large-scale trial starting immediately.
Hydroxychloroquine is used to treat arthritis and prevent and treat malaria. Lopinavir/ritonavir, branded as Kaletra, is used to treat HIV. Both have been used to treat coronavirus patients around the world, with little data yet on whether they work.
Melbourne infectious diseases expert Associate Professor Steven Tong, who leads the trial, said both drugs had been shown to stop COVID-19 in its tracks in the laboratory, but more research was needed into whether they worked in people.
The trial, at more than 80 hospitals in Australia and New Zealand and involving up to 2500 people, would test whether the drugs stopped patients deteriorating to the point of needing to be admitted to intensive care.
Patients in hospital but not in intensive care would be randomly allocated to one or the other drug, or both together, and some would receive neither. As a result, up to three-quarters of hospitalised patients could be treated with one or both of the drugs, researchers said. The study is not blind, so patients will know whether they are receiving a drug.
The study has also been designed so that it can shift to one or the other drug if it is working, one can be dropped if it causes severe side effects, and other drugs can be included.
The trial doesn't include remdeservir, which drug firm Gilead is restricting to countries with bigger outbreaks of coronavirus, but if it becomes available it will be included, researchers said.
Chief Investigator Professor David Paterson, from the Royal Brisbane and Women's Hospital, said both drugs had "a known array of side effects" because they had been used for many years. Because both could impact the heart, researchers would be watching closely for cardiac toxicity. There could also be specific side effects in coronavirus patients that were yet to show up.
Twenty hospitals are expected to begin the trial over the next fortnight, with more to follow, and researchers were also looking to expand the work to Singapore, given the very small numbers of hospitalised patients in Australia - just 170 on Monday. The work could take 12 to 18 months but would depend on numbers.
"We're ready and waiting," Professor Paterson said. "We really want to find results as quickly as we can."
Doherty Institute director Sharon Lewin said both lopinavir/ritonavir and hydroxychloroquine, while "not super-potent", had direct activity against the virus in the test tube.
President of the Australasian Society for Infectious Diseases Professor Josh Davis said the coronavirus patients would be treated for seven to 10 days with a much higher dose than being used in a separate study on hospital workers.
In the study of hospital staff, the Walter and Eliza Hall Institute is trialing hydroxychloroquine as a preventive, taken over three months.
Separately again, an international study (known as REMAP-CAP) is being done with patients in intensive care, led in Australia by Monash University.
Professor of infectious diseases at the Australian National University Peter Collignon said to date there was little evidence the drugs worked so good research was vital.
"I support doing a trial as long as people realise this isn't the definitive trial," he said.
"You have to be really careful when you are using drugs with unproven ability before you roll them out to huge numbers of people. Otherwise you can do more harm than good."
Prof Collignon said if the study was not blind it must be carefully randomised to prevent unconscious bias.
"We've got to be careful that panic doesn't induce bad medicine and bad research. It may be that no drug actually works against this virus and we need to accept that as a possibility," he said.
The British Medical Journal reports 80 trials of chloroquine or hydroxychloroquine worldwide, with the drugs thought to inactivate enzymes that viruses need to replicate and perhaps hinder the receptor that the coronavirus uses to enter cells. But results have been mixed, the transition from the laboratory to animal studies has been disappointing in the case of chloroquine, and trials to date have been small and marred by poor design.
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