Tag: Clinical trials

Better, quicker and more effective treatment for patients with sepsis

Sepsis kills five people every hour and accounts for about 50,000 deaths per year in the UK alone. To mark World Sepsis Day, Professor Anthony Gordon, Chief Investigator of the SepTiC study and Head of the Division of Anaesthetics, Pain Medicine and Intensive Care (APMIC), who is also a consultant in intensive care medicine and NIHR Senior Investigator, sheds light on how the study aims to find more effective treatment for sepsis patients.

Sepsis is one of the most serious conditions medical teams deal with. It’s life threatening and always considered a medical emergency. We don’t fully understand why it effects some people at different times but we do know it is caused by the immune system having an extreme response to an infection, most commonly due to an infection caused by bacteria. This causes organs to stop working properly and the body to damage itself because of that immune response, sometimes leading to multiple organ failure.

Patients with sepsis can deteriorate rapidly and this can sometimes be difficult to spot because the symptoms, such as fever, pain and breathlessness, are common to many other diseases. Anything we can do to improve care for these patients is vital to improving outcomes.

For patients receiving critical care in the intensive care unit, this can be even more challenging because they aren’t always able to tell us how they are feeling. But these patients are also at the highest risk because they are already so unwell.

This is why research to refine and improve treatments for sepsis is so vital – so we can respond as quickly as possible, in the most effective way, to help more patients make a full recovery, without lasting side effects.

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Why not eliminate HTLV-1 while eliminating HIV-1? We need HTLV-1 PEP/PrEP clinical trials.

Dr Goedele Maertens and Dr Fabiola Martin

HTLV-1 PrEP Open Letter to Gilead & ViiV 

Human T Lymphotropic/Leukaemia Virus-1 (HTLV-1) is a sexually transmitted infection (STI) closely related to human immunodeficiency virus-1 (HIV-1). HTLV-1 causes chronic infection, can be transmitted from mother to baby and is associated with significant disease burden and mortality, preceded by years of suffering and poor quality of life for victims.   

Therefore, HTLV-1 is one of the 2030 elimination targets of the World Health Organization’s global STI elimination strategy.  

Although there is currently no drug or vaccine available to cure HTLV-1, we now know that the very same drugs that effectively treat patients with HIV or prevent people from getting HIV-1, called HIV PrEP, also prevent the transmission of HTLV-1 in our laboratory testing (Reviewed in Bradshaw and Taylor, Frontiers in Medicine 2022). We believe that these compounds are likely to block the transmission from mother to child. 

It is well known that many HIV PrEP clinical trials are conducted in countries where HTLV-1 is common. So, by adding in HTLV-1 testing to these HIV-PrEP trials we could measure if the HIV PrEP drugs also prevent HTLV-1 transmission. The beauty of such an outcome would be that these HIV-1 drugs are already licensed to be used in humans.  

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Can we save lives by deliberately infecting people?

A person's arm being injected

In the middle of the pandemic, scientists intentionally infected healthy volunteers with SARS-CoV-2, the virus that causes COVID-19. John Tregoning, Reader in Respiratory Infections at the Department of Infectious Disease, explains why these experiments, and the volunteers who take part in them, are critical to modern medicine.

In early March 2021, in the middle of the COVID-19 pandemic, a surprising-sounding set of experiments were taking place. Researchers at Imperial College London (and separately at the University of Oxford) were deliberately infecting healthy volunteers with SARS-CoV-2. This was in fact the latest in a long line of controlled human infection studies – where volunteers are deliberately infected with an infectious pathogen under extremely controlled conditions.

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Consulting and involving the public in the first human COVID-19 human challenge study

How do you engage members of the public with medical research? Dr Emma Smith, HIC-Vac Network Manager, outlines how consulting the public was crucial during the world’s first COVID-19 human challenge study.

It is important that health and social care research aims to improve the overall well-being of the population, from advancing treatments for patients to helping us live healthier lives. People are at the heart of medical research and so engaging and involving them is an integral part of the research process and one that is mandated by most funders.

When we set up the world’s first COVID-19 human challenge study, acceptability of research to participants and society more broadly was particularly relevant because of the study’s ethically complex nature.

With volunteer participants being deliberately exposed to coronavirus (COVID-19) and the associated risk (albeit very small) of serious illness or death, the public’s perspectives were an important element of assessing if the study was acceptable and ethical (and was stated by the WHO1  as one of the key criteria for the ethical acceptability of COVID-19 human challenge). (more…)

A week in the life of a Clinical Research Fellow

Dr Francesca Conway takes us through a typical week as a clinical research fellow and how her previous time at Imperial contributed to her developing an interest in a career in clinical academia.

Monday

6am. I’m awakened by the horrifically jolly alarm tone on my phone. It’s still dark, it’s still raining, and it’s still cold. Hedgehogs have the right idea hibernating over winter, I think, as I haul myself out of bed.  Must consider this hibernation proposition in my next supervisor meeting. 1 shower, 1 yoghurt and 3 smoothies later and I’m in the hospital.

Today I have a patient coming to see if she is eligible to be recruited to the clinical trial which forms part of my PhD. Mrs X has travelled from 300 miles away. She greets me with a smile and tells me how pleased she is to be here. I immediately remember why I love my job, and scrap the idea of hibernation. I offer her a coffee, she gratefully accepts and whispers, could I have an extra shot in that? I assume she means coffee. I wonder what time she woke up, but am pretty sure it was before 6am.

I am researching a potential new treatment for Chronic Cbstructive Pulmonary Disease (COPD) for my PhD. Mrs X suffers with COPD, a disease affecting the lungs most commonly caused by smoking. More than 3 million people die from it each year. Targeted Lung Denervation or “TLD”, is a non-surgical procedure where we deliver energy to the airways using a system made by Nuvaira, a US-based company. The idea is that the energy disrupts the nerve supply to the lungs, so the airways relax and open. With initial data looking promising, we hope that this will lead to improvements in health for patients like Mrs X. More information on the Airflow website. (more…)

COVID-19 vaccine diaries: part two, safety first

Justine is a participant in Imperial’s COVID-19 vaccine clinical trial – here she discusses how the trial is progressing. 

“Am I immune?” “Could I be immune?”

These are questions that have been unavoidably circling in my head ever since I received an experimental coronavirus vaccine as part of a clinical trial led by Imperial College London. 

Every time I exercise, take public transport, do my weekly food shop, socialise with those close to me, I’ve been trying to quash this invisible shield that part of my brain believes might be there, shrugging off any potential encounters with the SARS-CoV-2 virus. 

I didn’t enter this trial so that I’d get a free pass to behave irresponsibly in the midst of a pandemic, which is frighteningly rearing its ugly head again in my home country. I always knew that immunity was never a certainty, having never been tested in human beings before. I was more confident that it wasn’t a dangerous thing for me to do, and certain that it was a good thing to do. 

And by participating, I have certainly helped to prove both of these latter points. I’ve had two shots of the vaccine, which works by instructing my cells to make fragments of the coronavirus, thereby prompting my immune system to react and, hopefully, keep a protective memory of the threat. I’ve had no side effects at all; not even a sore arm. The devil on my shoulder sort of wished for even a little redness where the needle went in, that I could wear proudly as a mark of my contribution to research.  (more…)

COVID-19 vaccine diaries: part one, my first dose

Justine is taking part in Imperial’s COVID-19 vaccine clinical trial – here she shares her experience of receiving the first dose.

It’s a strange feeling that as I write this, the cells in my arm are reading a message that scientists planted there just hours ago. 

That message – a strip of genetic code – contains the recipe for making part of the virus that causes COVID-19, SARS-CoV-2. This is the ‘spike’ protein that the virus uses to lock on to cells and invade them. The hope is that by telling my cells to churn out this molecule, my immune system will launch an effective and lasting response that could make me immune to the coronavirus. 

That’s the theory, anyway; we won’t know whether this experimental vaccine works until scientists have carried out rigorous clinical studies and gathered enough data to be confident of how safe and effective it is. And today I was part of that clinical research. 

I’m one of 120 people who have so far been selected to take part in one of the earliest phases of a clinical trial that’s testing Imperial’s newly-developed coronavirus vaccine. As soon as I spotted that the trial was recruiting participants, I immediately slotted my details into the online form to express my interest in joining, and eagerly awaited a response. (more…)

Is mycoprotein an ideal food for managing blood sugar levels in Type 2 Diabetes?

For Diabetes Awareness Week, Anna Cherta-Murillo explains how mycoprotein, a food made of fungus, may hold the promise for managing blood sugar levels in Type 2 Diabetes.

If I were to ask you the first thing that comes to mind when you think of fungi, you would probably say mouldy walls, gone-off food, or athlete’s foot. The Fungi kingdom is often not viewed in a positive light. However, we owe a lot to fungi; they produce life-saving antibiotics, have allowed organ transplantations in humans and can recycle many types of waste. In the area of nutrition, some fungi also have the potential to affect human health in a beneficial way, although little research has been devoted to it compared to other foods. In the Nutrition Section of the Department of Medicine at Imperial, we are putting fungi into the limelight and studying the impact of a particular type of fungus on blood sugar levels and appetite in South Asian and European people with Type 2 Diabetes (T2D).

The problem

1 out of 20 people worldwide has T2D, with South Asians being more prone to the disease compared to Europeans (Figure 1). People with T2D have higher blood sugar levels than normal, which over time can increase the chances of developing long-term complications such as blindness, kidney disease and heart failure. It is therefore important to manage blood sugar levels in people with T2D in order to keep blood sugar in the normal range. The first-line strategy to achieve this is by improving dietary intake. Healthy, balanced diets are generally characterised as being high in dietary fibre and protein, which decrease both blood sugar levels and appetite. If blood sugar levels are reduced toward normal levels, the chances of having T2D-related complications are reduced. Likewise, if appetite is decreased, intake of energy-rich foods will likely also decrease, helping to reduce body weight, which is a key risk factor for T2D. However, an ongoing problem with healthy diets is that they are not suitable for all cultures and most of the research around them has been conducted in people of European origin, therefore not being applicable to South Asians. Furthermore, people often find it difficult to stick to these diets. (more…)

Could the EndoBarrier be the next weapon of mass reduction?

Endobarrier

In this post, Dr Aruchuna Mohanaruban tackles the most asked questions about the EndoBarrier – a medical device for the treatment of type 2 diabetes and obesity.

UK obesity rates have continued to rise at an alarming rate, with figures higher than any other developed nation. Strongly associated with obesity is the increased susceptibility to developing type 2 diabetes (T2DM) which currently affects 3.2 million of the UK population. Bariatric surgery – a type of surgery aimed at inducing weight loss – usually by altering the stomach and/or intestines has revolutionised the treatment of these conditions and can lead to a 60% remission in diabetes. However, with demand for this type of surgery outstripping supply, there is a greater need to develop non-surgical alternatives to combat the ever-rising obesity and diabetes epidemic. (more…)