Researchers from the Medical Research Institute of New Zealand (MRINZ), the country’s leading independent medical research organisation, will lead three major, internationally-significant trials in the fight against COVID-19, funded by the Health Research Council of New Zealand.
“I applaud the HRC for funding these important, randomised clinical trials across the spectrum of COVID-19 disease severity, from mild disease through to critically ill patients admitted to the Intensive Care Unit.” says MRINZ Director Professor Richard Beasley.
“The clinical trials will assess multiple potential therapeutic agents including hydroxychloroquine, one of a number of drugs gaining media attention as a potential treatment for COVID-19. These grants recognise the importance of both international collaboration and the timely need to protect our healthcare workers on the frontline of this crisis”.
The largest of the MRINZ-led COVID-19 trials is REMAP-CAP (Randomised, Embedded, Multifactorial Adaptive Platform Trial for Community-Acquired Pneumonia) which was already underway, but designed to adapt should a pandemic occur.
The trial involves researchers and participants from more than 65 Intensive Care Units (ICUs) in 13 countries worldwide, and is led by researchers in Australia, New Zealand, UK, the Netherlands, Canada and the USA.
Trial co-leader, Auckland City Hospital Intensive Care specialist Dr Colin McArthur, says the study will assess multiple unproven potential treatments, including anti-viral agents such as lopinavir/ritonavir (“Kaletra”), hydroxychloroquine, the anti-inflammatory antibiotic azithromycin, steroids and other immune modulating therapies, compared to full standard supportive care.
Dr McArthur says it’s a platform study, where multiple interventions can be tested at the same time, adapting further as evidence accumulates.
“It will be reassuring for New Zealand COVID-19 patients to know we are part of this trial and that they’ll get treated with what is more likely to be effective, with less time wasted on things that aren’t” says Dr McArthur. “It allows us to evaluate several treatments at the same time, in the same patient, combining the results from around the world, then use this to influence care for future patients, to ensure they too are more likely to receive the best treatment regime available. We can quickly drop treatments if they are shown to be less effective than others or worse than standard care, and add others to the study over time if need be. New Zealand patients in the study will also be helping other ICU patients the world over, with their results shaping international clinical management of COVID-19 in the very sickest patients”.
MRINZ’s second study will compare the efficacy of hydroxychloroquine against placebo in adult New Zealand patients diagnosed with COVID-19 in the community not requiring hospitalisation.
In this study, supported by HRC Independent Research Organisation funding, seventy volunteer patients, initially from Auckland and Wellington, will be recruited into the trial, documenting and recording their symptoms for 28 days.
This clinical trial represents a collaboration between the MRINZ and regional public health services, and will be initiated if there is an increase in the rate of COVID-19 infections later in the year.
“This trial is significant as medications may be more likely to be effective when given in the early stages of the disease” says Professor Beasley. “This study will provide evidence on which the efficacy and safety of hydroxychloroquine can be based, and if effective, reduce the burden of COVID-19 admissions on the hospital system”.
The third MRINZ study seeks to provide evidence on a treatment that might protect frontline healthcare workers at heightened risk due to repeated exposure to patients with COVID-19.
The randomised trial will test hydroxychloroquine as a prophylaxis treatment, potentially preventing workers from contracting the disease.
Lead investigator and Wellington Hospital ICU specialist Dr Paul Young says the trial, which will start if the number of cases of COVID-19 increases in New Zealand over the next few months, will involve a range of frontline healthcare workers. It is believed to be the first such trial registered internationally which assesses the weekly hydroxychloroquine regimen established for malaria prophylaxis.”
“In Italy we’ve seen COVID-19 completely overwhelm the healthcare system, stressing how important it is for all countries to have frontline health workers fit and able to meet demand, both now and during future surges of the virus” says Dr Young.
“Once infected, not only are healthcare workers off work and their colleagues also forced into self-isolation, but they may have transmitted the virus to vulnerable patients in their care before becoming symptomatic. This study will assess the potential efficacy of a simple, oral, safe and low cost, weekly prophylactic hydroxychloroquine regime for these high risk workers”.
MRINZ also has a small involvement in the Australasian COVID-19 Trial (ASCOT), a collaborative trial led in NZ by Dr Susan Morpeth at Middlemore Hospital. This study evaluates lopinavir-ritonavir (“Kaletra”, an antiviral approved for use in HIV infection) and hydroxychloroquine alone or in combination, compared to full standard supportive care, in patients hospitalised with COVID-19.
The HRC says itself and the Health Ministry received unprecedented interest in it’s COVID-19 rapid research call.
“These clinically focussed MRINZ studies are an important group among those we were able to fund” says HRC Chief Executive Professor Sunny Collings. “The MRINZ receives $566,000 a year from the HRC over and above specific grant funding, so it’s great to see the extra value created through the combination of funding.”
“We are extremely fortunate to live in a country where the government recognises the importance of scientific medical research.” says Professor Richard Beasley. ”Rather than take a gamble on a medication without evidence of its efficacy or safety, the HRC has funded randomised, controlled trials of potential treatments across the spectrum of disease severity and clinical situations, and will thereby gain knowledge of their benefits and risks, to guide clinical practice in New Zealand and internationally”.