This page is being updated as and when there are changes or developments with these trials.
Last updated 22 January 2021
On 17 April 2020, the Health Research Council and Ministry of Health announced funding for three clinical trials into potential COVID-19 treatments. These were among 13 studies funded to help combat COVID-19 and prepare New Zealand for future infectious diseases.
Initially, all three clinical trials planned to include hydroxychloroquine in their evaluation of potential treatments for COVID-19, however given the rapidly emerging evidence on potential COVID-19 treatments from other international trials, all three trials have adapted significantly and have removed hydroxychloroquine as a candidate for treatment or prevention. In addition to this, low case numbers in New Zealand has meant recruitment to the two patient trials has been limited.
Status of each trial:
- The REMAP-CAP COVID Trial is an international multi-centre trial. Its New Zealand arm is open, however recruitment has been limited given the low number of COVID-19 cases in ICUs. Hydroxychloroquine was removed from the trial, but thanks to its adaptive platform the trial has continued to evaluate other potential therapies, including convalescent plasma*, immune-modulation treatments other than steroids, anti-coagulation strategies (including anti-platelet agents), ACE2 receptor targeted therapies, vitamin C, simvastatin and ventilatory strategies.
Among the trial's findings to date:
This trial was part of the WHO-led meta-analysis, published in JAMA, whose findings into corticosteroid use in critically ill COVID-19 patients led to new WHO guidelines and changed treatment in ICUs worldwide. Then in November 2020, preliminary findings from this trial showed that treatment with the immune modulator ‘tocilizumab’ reduced time spent on organ support in intensive care among critically ill patients with severe COVID-19, compared to patients who did not receive any immune modulation treatment. In January 2021, the BMJ reported results from the trial showing tocilizumab and sarilumab reduced mortality from 35.8% to 27.3% compared with standard care - an absolute reduction of 8.5% and a relative reduction in mortality of 24%.
- The ASCOT Trial is being carried out in Australia and New Zealand. It is now open at Middlemore Hospital and Auckland City Hospital and will open in several other sites around the country soon. Under a revised study protocol (which aligns with its partnering Australian sites that have removed hydroxychloroquine and lopinavir/ritonavir from testing) the trial will be randomising eligible consenting hospitalised patients with COVID-19 to convalescent plasma or standard supportive care.
- Finally, the clinical trial of hydroxychloroquine prophylaxis in frontline healthcare workers will not proceed beyond the trial set-up phase. No New Zealand healthcare workers will be recruited. This decision is largely based on the emerging lack of evidence of efficacy for hydroxychloroquine in COVID-19 treatment. The trial will be funded to the end of the trial set-up phase only. Completing the set-up phase will put researchers in a position to re-initiate a healthcare worker prophylaxis study in the future, should this be needed. Such a study would not involve hydroxychloroquine but an alternative medication. No decision has been made on the reallocation of unused HRC funds at this time (about $300,000).
The HRC and Ministry of Health view these clinical trials as an important component of New Zealand’s preparedness and response to community transmission of COVID-19.
In the absence of a vaccine, the clinical trials provide access to the latest emerging evidence on prophylaxis and treatment. REMAP-CAP COVID uses an adaptive design, and New Zealand’s ASCOT Trial has moved towards one, which means these trials have the ability to adapt in line with emerging evidence on promising treatments. This means that patients within these trials are randomised to treatments that are more likely to be beneficial, while interventions determined to be inferior are discontinued.
*Convalescent plasma: As part of the immune response, people recovering from COVID-19 can develop antibodies targeting parts of the SARS-CoV-2 virus. These antibodies are contained in the liquid part of the blood, the plasma, and can be given to patients newly infected with COVID-19 via plasma transfusion, potentially resulting in more rapid control and clearance of the virus.
Below are links to the initial lay summaries for each trial, as submitted to the HRC during the rapid response funding call. Please note, these studies have since removed hydroxychloroquine from testing and, subsequently, this treatment has not been used in COVID-19 patients in New Zealand.
- Clinical trial of COVID-19 treatments for the critically ill (REMAP-CAP COVID)
Dr Colin McArthur, Medical Research Institute of New Zealand
- Australasian COVID-19 Trial (ASCOT)
Dr Susan Morpeth, Middlemore Clinical Trials
- Clinical trial of hydroxychloroquine prophylaxis in frontline healthcare workers
Professor Richard Beasley, Medical Research Institute of New Zealand