As the world attempts to deal with the COVID-19 pandemic, clinicians and scientists around the world, including our own at the Trust, are working around the clock to find effective treatments.
Research forms the backbone of the work we do to provide the best possible specialist care for our patients, and in early March over 200 studies were taking place into cardiovascular and respiratory conditions, across Royal Brompton and Harefield hospitals. The majority of these have been put on hold to ensure the safety of patients and volunteers, and to free up staff to focus on COVID-19 research activity.
Several COVID-19 research studies have been approved and are actively recruiting across both hospitals. Some will be testing existing treatments that are already in use for other diseases, others will involve determining any genetic variation between patients and how this affects the development of the disease.
They have been chosen because they hold the greatest potential for tackling the virus and are designed to gather the necessary clinical and epidemiological evidence that will inform national policy and enable new diagnostic tests and treatments to be developed and tested.
The Trust’s COVID-19 research would not be possible without the support of frontline and critical care staff as well as the existing research staff who have been redeployed to support the research activity. Patient advisory groups have also been supportive in contributing to the necessary information to help guide research staff when obtaining consent from relatives over the phone.
Lyndon Bridgewater, associate director of research at the Trust, said: “Our participation in these nationally prioritised research studies is vital, the contribution this research makes to the understanding of COVID-19 is of great importance in tackling the virus.
“We are extremely grateful for the dedication of all those involved in the delivery of this research, as well as our patients and their families who agree to participate. Without all of this support the research would simply not be possible.”
Many more projects are also in the pipeline, some awaiting funding and others seeking the necessary regulatory approvals before starting. These studies are not limited to patients who are critically ill but include a vast cohort, including survivors and staff members.
Some of the actively recruiting studies are detailed below.
RECOVERY (Randomised Evaluation of COVID-19 Therapy)
This clinical trial is testing some of the treatments which have been suggested for COVID-19. Any new information on potential or promising new drugs will be reviewed regularly and included in the trial where appropriate.
The drugs currently included in the trial are:
- Lopinavir-Ritonavir (commonly used to treat HIV)
- Low-dose Dexamethasone (a type of steroid)
- Hydroxychloroquine (related to an anti-malarial drug)
- Azithromycin (a commonly used antibiotic)
Data from the trial will be regularly reviewed so that any effective treatment can be identified quickly and made available to all patients.
The study is led by Dr Anand Shah, consultant respiratory physician at Royal Brompton Hospital, and Dr Anna Reed, consultant in respiratory and transplant medicine at Harefield Hospital, in collaboration with the University of Oxford.
DeVENT (Decision Support System to Evaluate VENTilation in ARDS)
Patients with severe symptoms of COVID-19 may develop a condition known as Acute Respiratory Distress Syndrome (ARDS) and require mechanical ventilation, which takes over breathing for the patient.
The DeVENT trial is testing a new device called the Beacon Caresystem which is connected to a ventilator to help monitor the effect that the mechanical ventilation is having on a patient’s lungs.
The device will advise the clinical team of appropriate ventilator settings and help them decide which type of ventilation is working best for the patient. The study will be looking to answer important questions such as:
- What is it that defines and drives lung damage and critical illness in COVID-19?
- What is causing a lack of oxygen reaching parts of the body and what is the best way to combat this?
- When are interventions like ECMO, prone positioning (patients placed on their front) and recruitment manoeuvres (opening up collapsed airless alveoli) most beneficial?
The study is led by Dr Brijesh Patel, honorary consultant at the Trust, in collaboration with Imperial College London.
GenOMICC (Genetics of Susceptibility and Mortality in Critical Care)
This study, also led by Dr Brijesh Patel, aims to help understand the variable responses seen in patients with COVID-19. It is believed that there may be a genetic element at play which determines an individual’s susceptibility to the virus and how it develops in the body. GenOMICC aims to find the genes that cause susceptibility, which will help prioritise treatments.
REMAP-CAP (Randomised, Embedded, Multifactorial Adaptive Platform trial for Community-Acquired Pneumonia)
This is an adaptive clinical trial which will evaluate a number of treatment options for patients who develop community acquired pneumonia (CAP) as a result of COVID-19. The design of the trial increases the likelihood that patients will receive the treatment that is most likely to be effective for them.
The potential treatments that will be tested currently include:
- Macrolide therapy as a modulator of immune function
- Different corticosteroid strategies
- An antiviral therapy (lopinavir/ritonavir)
- Immune-modulating therapies (interferon-beta-1a and interleukin-1 receptor antagonist).
The trial is led by Dr Anna Reed at Harefield Hospital and Dr Brijesh Patel at Royal Brompton Hospital.
ISARIC/WHO Clinical Characterisation Protocol (CCP) for Severe Emerging Infection
This study, led by Dr Brijesh Patel, aims to better understand the virus, its spread and behaviour. This will be done by analysing biological samples and data from patients with confirmed cases of the disease across the UK. The data will be used to help control the outbreak and improve treatment for patients by generating important evidence around:
- Who in the population is at higher risk of severe illness
- What the best way is to diagnose the disease
- What actually happens in immune systems to help or harm patients
- The effects of drugs used in patients with COVID-19
- How long people are infectious for, and from which bodily fluids
- Whether people are infected with other viruses (e.g. flu) at the same time.