As COVID-19 continues to grip the world, there are hundreds of programs trying to find out more about the disease and hopefully beat it.

Most prominently there are over a hundred potential vaccine candidates, but there are also studies into non-vaccine treatments as well as studies trying to find out more about the disease and the body’s response to it.

Monash University is currently undertaking a study to try and understand how the immune system responds to the infection through the analysis of blood and respiratory samples.

Stockhead spoke with Dr James McMahon, the head of clinical research at the Alfred Hospital and Monash University, for some insights into the study and the battle against COVID generally.

 

Monash has described the study as “cracking the immunity code”, can you tell us a bit more about clinical trials to treat COVID-19?

“We’re very interested in why some people with COVID-19 don’t get sick but others get unwell and die.

“We are working with scientists, and immunologists to understand how the immune system is responding and whether it is being overwhelmed by the virus – potentially responding in a way that is harming the body.

“We’re testing people in hospitals but also people who didn’t come to hospital. We’re getting blood samples from those who have done well in the way they’ve responded and comparing these to samples in patients with alternative outcomes.”

 

What can you tell us about clinical trials to treat COVID-19?

“We know there are dozens of clinical trials going on around the world, many of them studying medications that are used for other conditions but thought to have some activity against COVID infection.

“These clinical trials will recruit thousands – these large trials will be the ones that can answer the question

“The data we’ve got now is from a small number of individuals and it doesn’t provide answers.

“What you need is large randomised controlled trials – where someone enters with infection and they get the drug of interest or nothing. Then you follow for two to three weeks and identify the difference in the outcomes. Randomised, controlled trials make the difference.

“You need to see which group really got the benefit, the people who got it soon after being unwell or for a long time? Did it have other effects — maybe was it harmful? All of those are important.”

 

Generally speaking, how does a clinician determine treatment candidates?

“In general there’s two broad types of treatment candidates being investigated.

“One is an anti-viral, hindering COVID’s ability to make new versions of itself. The most common organ it infects is the lungs, so there’s anti-viral drugs being repurposed that have been used in other diseases.

“The other big group of drugs is trying to suppress or modulate the response to the virus. It’s recognised some people get a maladaptive immune response where their body goes overactive to fight it to the point of damaging the patient.

“For instance severe immune responses referred to as cytokine storms have occurred in some patients causing organ failure.

“We’re lucky because we haven’t had as much of the disease, we haven’t done as many trials. But trials of immune modulating drugs are being performed in the US and Europe and will be interesting to see, but later down the track.”

 

When can we declare “we have a vaccine”? When it passes a phase three trial?

“Typically, what a vaccine would need to be licensed for use to prevent the infection is trials of hundreds or thousands of people showing it prevents it in a large portion of individuals.

“Phase one shows people tolerate the vaccine and don’t get sick. The second is where people show the immune system is responding, which is what the vaccine is meant to do. It’s meant to mimic the infection and wake up the immune system, so when you get it your system can fight it.

“Then they do a larger study — phase three which recruits hundreds or thousands of people to understand whether the vaccine protects against the infection.

“It’s one thing to show an immune response but you need to show that it is effective – that it stops people getting the virus.

“Often vaccines take several years, it doesn’t take one or two. I suppose the difference here is that there are so many things running in parallel.”

 

With the SARS epidemic, which was also a coronavirus, I understand there were vaccine trials but they were abandoned when the disease faded out. What can we learn from the early stages of those trials?

“You’re right. While I am more involved in the [COVID-19] treatment trials, I do know some groups working on vaccines are people that’ve already been working on coronaviruses and extended COVID-19 into the field.

“SARS was an epidemic that burnt out and there was discussion as to why. It’s not as infectious as COVID-19, one catalyst was warmer months coming in the Asian countries.

“There was speculation it would happen with COVID-19 but it hasn’t. I think COVID-19 is a different virus, more infectious and transmissible and creates disease.”

 

Let’s say a trial overseas comes up with a vaccine, do you forsee Australia dropping everything and trying to manufacture it?

“Ultimately it will be the government determining that, but if there was a successful vaccine I think they’ll do all they can to get access to it or if they can manufacture it, do it.

“If you look at a disease there’s lots of weapons in the tool kit to fight them. A vaccine is one thing, but there are antiviral medicines and infection prevention measures, where we stop sick people going to work, coughing into their arms, not going onto transport if they have it.

“It is same thing with COVID, it’s unlikely there’ll be one intervention. At the moment it’s the latter – preventative measures. These are effective but we cannot go on living like this forever.

“It’s lucky we have control of the situation and the brakes will come off but a lot of measures will stay in place, particularly those stopping cases being imported.”

 

Could this pandemic see the government become more involved in medical research into infectious diseases in the future?

“I’m biased but I’d like the answer to be yes … ongoing investment, you would think, in infections that have potential to cause pandemic.

“Because of the huge impact it has on health, suffering, dislocation and the financial hit society suffers. If we are better prepared for pandemics in the future, all governments would see a benefit to that.

“We’re thinking more about the present than the future but pandemics occur intermittently.  Hopefully the government sees it as an ongoing requirement for public health and have the critical elements required to respond to this.”

This article has been updated to correct certain factual inaccuracies.

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