Rheumatologist leads hydroxychloroquine prevention trial for healthcare workers

SVHM team: Prof John Santamaria (ICU), A/Prof Mandana (Mandy) Nikpour, Ms Jennifer Holmes [ICU], Dr Katherine Ellis [Rheumatology] and Mr Roger Smith [ICU]

Hydroxychloroquine may be officially out of favour as a treatment for severe COVID-19, but Australian rheumatologists are pressing on with a COVID-19 prevention trial to investigate the drug for protection of healthcare workers exposed to the virus.

Associate Professor Mandana (Mandy) Nikpour, a consultant rheumatologist at St Vincent’s Hospital Melbourne (SVHM) is one of the lead investigators of the COVID SHIELD clinical trial that seeks to recruit 2250 healthcare workers who are caring for COVID-positive patients

COVID SHIELD Clinical Trial is a collaborative project led by the Walter and Eliza Hall Institute of Medical Research, in partnership with human data science company IQVIA and various healthcare providers across the country, including SVHM, which is a screening site for the trial and has been heavily involved in the design of the study.

Associate Professor Nikpour says the need for an effective preventive agent is highlighted by the fact that more than 10% of COVID-19 cases in Australia are linked to healthcare workers, and more than 1000 have already infected.

“For every healthcare worker who is infected, quite a few then have to be tested, or go into self-isolation for two weeks. This has had an impact on the physical and mental health of healthcare workers, as well as an impact on the workforce we have available to undertake frontline duties,” she says.

Despite the negative results from trials as a treatment for COVID, Associate Professor Nikpour says there is still a scientific rationale for using lower doses as prophylaxis against the virus.

“In the test-tube, hydroxychloroquine reduces the replication of SARS Coronavirus 2, which is the COVID-19 virus, by about 90 percent,” she explains.

“When you are very sick or ventilated in hospital you have a lot of inflammatory molecules causing collateral damage to organs, and it is not possible at that point to intervene with a drug like hydroxychloroquine. However, hydroxychloroquine could potentially reduce the risk of COVID-19, if taken prior to exposure to the virus, that is, as ‘pre-exposure prophylaxis’ or ‘PrEP’.”

Healthcare workers who join the trial will regularly report, via an electronic data-capture platform, any COVID-19 symptoms they may be experiencing and whether they have been tested for the virus or been diagnosed with it.

“They also get smartphone alerts daily to remind them to take their medication and monitor their progress, including any side effects. The eDiary also checks whether they have had contact with anyone who has tested COVID-positive,” Associate Professor Nikpour says.

With Victoria recording the highest number of cases across the country to date,  the team will be looking to recruit about 650 participants locally, with almost 40 participants recruited from the SVHM campus to date, only three weeks into recruitment at this site. Many more are registering interest on the recruitment hub and will be enrolled in the coming weeks.

“So much of what is happening right now is out of our control, but this trial is making us feel empowered again. The people we are enrolling often tell us the trial is giving our healthcare workers some hope.”

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