Tag Archive for: COVID-19

New research shows steroid improves survival of critically ill Covid-19 patients

September 2, 2020

New research published today (02 September) has been able to show that using the steroid hydrocortisone on patients with severe COVID-19 symptoms improves their recovery.

Patients, NHS trusts and local research teams at hospitals across the Eastern region including Cambridge University Hospitals, have contributed important data to new global research which shows that corticosteroids can significantly improve outcomes for severely ill patients with COVID-19.

The research papers published in the Journal of the American Medical Association (JAMA) reinforce evidence that these inexpensive and widely available drugs improve outcomes for the most critically ill patients with the disease. One paper suggests the risk of death can be reduced by up to 20%.

The papers include findings from the National Institute for Health Research (NIHR) supported REMAP-CAP study, which is being conducted across 15 countries around the world and led in the UK from the NIHR Imperial Biomedical Research Centre.

Working closely together to help deliver rapid recruitment, NHS trusts and the NIHR’s Clinical Research Network (NIHR CRN), and research institutes from the devolved nations helped recruit 71% of all global study participants from right across the UK.

The results from the REMAP-CAP trial show a high probability that among critically ill patients with COVID-19, treatment with a seven-day course of hydrocortisone improved outcomes such as survival and more rapid recovery, compared with no hydrocortisone treatment.

An additional paper, co-ordinated by the World Health Organisation (WHO) and led by researchers at the University of Bristol and the NIHR’s Bristol Biomedical Research Centre, provides a meta-analysis (evidence summary) of global steroid use across seven randomised controlled trials (RCTs) in 12 countries spanning five continents. It also included data drawn from REMAP-CAP and the NIHR-funded RECOVERY trial, which has already shown that the steroid dexamethasone can be successfully used in treatment of moderate to severe Covid-19. It concludes that corticosteroids can reduce the risk of death in the most ill patients by up to 20%.

Dr Charlotte Summers, Principal Investigator for the REMAP-CAP trial at Cambridge University Hospitals (one of the region’s sites delivering the trial) and Critical Care Lead for the NIHR Clinical Research Network Eastern, said:

“This result from REMAP-CAP provides further support for the finding from the RECOVERY trial, suggesting that steroids improve survival for critically ill people with COVID-19. The breakthroughs we have made so far are testament to NHS teams unwavering determination to improve the outcomes of our patients by offering them the opportunity to participate in research.

“There are still more questions to be answered in relation to COVID-19, but with our country’s unique NIHR community, along with those who participate in research, we’re in the best possible position to succeed.”

NHS chief executive, Sir Simon Stevens said: “One of the distinctive benefits of having our NHS is that we’ve been able to mobilise quickly and at scale to help researchers test and develop proven coronavirus treatments. Just as we did with dexamethasone, the NHS will now take immediate action to ensure that patients who could benefit from treatment with hydrocortisone do so, adding a further weapon in the armoury in the worldwide fight against Covid-19.”

Dr Charlotte Summers, Principal Investigator for the REMAP-CAP trial at Cambridge University Hospitals explains the importance of the study.

Combining PCR and antibody tests at point of care dramatically increases COVID-19 detection in hospitalised patients

September 2, 2020

Cambridge University Hospitals has piloted the use of combined rapid point-of-care nucleic acid and antibody testing for SARS-CoV-2 infection after researchers at the University of Cambridge showed that this approach was superior to virus detection alone for diagnosing COVID-19 disease.

Point-of-care testing – in other words, testing patients as soon as they arrive at the hospital – is essential for enabling healthcare workers to rapidly diagnose patients and direct those who test positive for infection to dedicated wards. A recent study showed that SAMBA II, a new point-of-care PCR test for SARS-CoV-2 developed by Cambridge researchers, was able to dramatically reduce time spent on COVID-19 ‘holding’ wards – allowing patients to be treated or discharged far quicker than with current lab testing set-ups.

PCR tests involve extracting a miniscule amount of RNA from the virus and copying it millions of times, creating an amount large enough to confirm presence of the virus. The virus is captured through a swab inside the nostrils and at the back of the throat. However, it can take as long as 14 days for an individual to show symptoms of COVID-19, by which time the virus may have moved away from the nose and throat and into the lungs and other tissues and organs, making it harder to detect via a swab test. As a result, studies have shown that PCR tests can miss as many as a half of infected patients five days after infection.

Antibody tests provide an alternative way of identifying infected individuals, but antibodies – molecules produced by our immune system in response to infection – generally do not appear until at least six days after infection.

Professor Ravi Gupta from the Cambridge Institute of Therapeutic Immunology and Infectious Disease at the University of Cambridge said: “We still do not have a gold standard test for diagnosing COVID-19. This poses a challenge to healthcare workers who need to make quick and safe decisions about how and where to treat patients.

“The two main types of test – PCR and antibody tests – both have limitations because of the nature of coronavirus infection and how our body responds. But we’ve shown that if you combine them and carry out both at point of care, their reliability can be hugely increased.”

Professor Gupta led a team that used the approach of combining rapid point-of-care PCR and antibody tests to diagnose 45 patients at Addenbrooke’s Hospital, Cambridge University Hospitals NHS Foundation Trust. The results of this peer-reviewed study are published in Cell Reports Medicine.

The patients, each of whom had suspected moderate to severe COVID-19 disease, provided nose/throat swabs for the tests detecting nucleic acid (virus genetic material) and blood serum for antibody testing an average (median) of seven days after the onset of illness.

The authors designed a gold standard reference test made of two parts, either of which could be positive to confirm COVID-19. The first part was an in vitro test where artificial SARS-CoV-2 viruses were made and mixed with serum from patients to see whether the serum contained neutralising antibodies. The second part of the gold standard was the standard Public Health England laboratory test looking for genetic viral material in nose/throat swabs. Using this gold standard, 24 of the patients had COVID-19.

Professor Gupta’s team used SAMBA II machines, developed by Cambridge spinout company Diagnostics for the Real World, for the nucleic acid tests, and a combination of two finger prick antibody tests, both of which test for antibodies against the spike protein on the surface of the SARS-CoV-2 virus.

Overall, the nucleic acid tests could identify eight out of ten patients with COVID-19, but when combined with the rapid antibody tests, 100% of the COVID-19 patients were correctly identified. Among the 21 patients who did not have COVID-19, there were four false positive results with one antibody test and only one false positive with the second antibody test, demonstrating that one performed better than the other.

“Combining point-of-care PCR and antibody testing could be a game-changer for rapidly identifying those patients with moderate to severe COVID-19 infection,” said Professor Gupta. “This could prove extremely useful, particularly in the event of a second wave arising during flu season, when it will not be immediately clear whether the patients had COVID-19 or seasonal flu.”

Professor Gupta envisages that hospitals deploying this approach would carry out a finger prick blood test and nose/throat swab at the same time on admission to hospital. The antibody test result is available within 15 minutes, but might benefit from confirmation with a second point-of-care antibody test. Importantly the study showed that the antibody tests can detect antibodies against a mutated form of SARS-CoV-2, D614G in spike protein, that has now become the dominant strain worldwide.

This approach could be particularly beneficial in low resource settings where centralised virology laboratories are scarce and the pandemic is expanding, said Professor Gupta. In addition, it removes the need for repeated nose/throat swabbing when the first test is negative and suspicion of COVID-19 is high, which may generate aerosols and lead to transmission.

The research was mainly funded by Wellcome and supported by the National Institute for Health Research Cambridge Biomedical Research Centre and the Cambridge Clinical Trials Unit.

TACTIC-E trial to test whether a simple microbe could be an effective treatment for COVID-19

June 23, 2020

As part of a new trial led by Cambridge University Hospitals and supported by NIHR Cambridge Biomedical Research Centre, a microbe will be used to treat severe COVID-19 in an experimental drug known as EDP1815. Developed by Evelo Biosciences, EDP1815 is a naturally occurring microbe that has been isolated from the small intestine of a human donor.

EDP1815 works by communicating with immune cells in the small intestine, which in turn communicate with other immune cells around the rest of the body. Via the gut immune cells, EDP1815 can broadcast a message to the immune cells in other organs to reduce production of the chemical messengers, known as cytokines, that cause inflammation (and damage to organs), while encouraging anti-inflammatory messages instead. Most importantly, EDP1815 does not affect cytokines known as type-1 interferons, which are essential allowing people to recover from infection. In this manner, the drug may support an immune response that is ‘just right’ – reducing harmful immune responses while supporting the immune system to clear the virus.

One of the key reasons for selecting EDP1815 for this study is its safety profile, which means it will be safer to use in many of the vulnerable groups that are at greater risk of COVID-19 complications. It is not absorbed into the body, and only persists while the patient continues on the drug.

EDP1815 is being tested as part of a newly launched trial, known as TACTIC-E, which has been designed to test experimental drugs that may treat COVID-19, as well as investigating whether combinations of drugs that are already in use for other conditions can be effective. As with similar trials, such as TACTIC-R and RECOVERY, further treatments can be added as they are identified. Each of the treatments will target as yet unexplored aspects of COVID-19, offering the chance to quickly test new treatments as well as shedding new light on how SARS-CoV2 causes such severe disease in some people.

A second arm of TACTIC-E aims to reduce the damage seen in the lungs of patients with severe COVID-19, using a combination of ambrisentan and dapagliflozin (both manufactured by Astra Zeneca), which are licensed for pulmonary hypertension (elevated pressure in the lungs) and type 2 diabetes respectively. People with cardio-metabolic diseases (such as obesity, type 2 diabetes, heart failure or kidney disease) are known to be at higher risk of serious complications from COVID-19.

Ambrisentan helps to relax the arteries within the lungs, improving blood flow and oxygen pick up as well as having an anti-inflammatory effect. Dapagliflozin, when used together with ambrisentan could help counteract changes in fluid distribution that ambrisentan can cause. Researchers also believe that dapagliflozin may have further beneficial effects for COVID-19 treatment, due to its ability to support heart and lung function by balancing glucose and sodium in the blood.

The TACTIC-E trial will recruit patients admitted to hospital with COVID-19 who are at risk of entering the second stage of COVID-19 disease, which occurs around the second week following infection. It is during this phase that immune damage and severe respiratory symptoms begin to develop, and researchers believe that the treatments being tested in the trial will be most effective during this period.

It is anticipated that fewer than 500 patients per arm will be needed to assess the effectiveness of each treatment, but as the number of people with COVID-19 continues to decline across the United Kingdom, there are plans to open the TACTIC-E trial in nations where infections remain high. This will ensure that researchers can quickly understand whether or not these treatments are effective.

TACTIC-E Principal Investigator and Consultant Clinical Pharmacologist at Cambridge University Hospitals NHS Foundation Trust (CUH) Dr Joseph Cheriyan, said “COVID-19 is a complex disease that affects people in different ways and we are going to need a range of treatments in our armoury to be able to beat it.

“On the Cambridge Biomedical Campus, we are uniquely placed to work in the NHS alongside academia and industry to bring early phase drugs into circulation, potentially making a massive difference to the lives of many, many people.

“We have brought all this experience to bear with TACTIC-E. We will be trialling treatments that a panel of independent experts consider most likely to work, which are either already licensed, or known to have excellent safety, and observe them very closely to see what happens in order to identify successful drugs early on.”

Professor Ian Wilkinson, Director of the Cambridge Clinical Trials Unit, and Professor of Therapeutics at the University of Cambridge said “As we enter the next phase of the COVID-19 pandemic, Cambridge is proud to play a role in the rapid evaluation of potential treatments.

“The TACTIC-E trial has been carefully designed to swiftly detect effectiveness of potential treatments using small numbers of patients. It has a strong focus on collecting high quality data to confirm safety and effectiveness, enabling our manufacturing partners to gain the necessary approvals for widespread international use.”

The trial is led by the Cambridge University Hospitals NHS Trust and is supported by the NIHR Cambridge Biomedical Research Centre. Funding and drug supply for the trial has been provided by Astra Zeneca and Evelo Biosciences.

Phased re-start of non-COVID-19 research

June 15, 2020

15 June 2020

In line with NIHR guidance, we are beginning the process of phased re-opening of some non-COVID-19 research studies, while maintaining our contribution to local and nationally prioritised urgent public health studies for COVID-19.

As COVID-19 related admissions continue to fall across our hospital trusts, local research studies will be prioritised as detailed below. However, as and when this situation changes, this process may need to be further adjusted or paused. Delivery of front-line care and COVID-19 research remains our priority, and all research delivery teams working within CUH will be allocated studies on this basis.

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Prioritisation of Studies

Level 1

Existing COVID-19 related research – nationally prioritised COVID-19 Urgent Public Health Research studies and CUH COVID-19 related research trials.

Level 2

Existing clinical trials and studies that are currently suspended, which offer potential therapeutic benefit to patients via improved diagnosis and/or a treatment/intervention improving or extending life.

Longitudinal follow-up studies of previous interventions; online staff research studies and studies where ALL participant study visits can be integrated with routine clinical management or conducted remotely without imposing major, immediate demand on research workforce and facilities.

Level 3

All other existing and new clinical research studies.

We anticipate that Level 3 studies will not be able to re-open until the national lockdown has been fully eased. When this occurs, we will provide further information and advice to this effect.

Urgent applications may be considered on a case by case basis.

Application for re-start

All studies must have Capacity and Capability (C&C) formally re-confirmed by R&D prior to recommencement. R&D sign off is in addition to other approvals required (for example, from the CRF or CCTU).

Principal investigators and study teams wanting to have their studies assessed for re-start need to complete the risk assessment form here.

R&D will assess the information provided in the risk assessment form to establish which studies are eligible for Level 1 or 2 prioritisation, and can therefore re-start/start all research activities. The availability of necessary supporting services (Pharmacy, Radiology, Labs, CRF, etc) and research staff will also contribute to the assessment.

NIHR centrally will monitor restart across England to identify and help to resolve any cross-cutting issues that may arise. To this end, a cross-Centre ‘NIHR Restart Implementation Group’ has been established, which will be chaired by Dr William van’t Hoff, CEO of the NIHR Clinical Research Network and Senior Responsible Officer for the NIHR Restart Programme.

Rapid COVID-19 test halves patient waiting times

June 5, 2020

A new diagnostic test that can diagnose COVID-19 in a hospital setting faster than standard testing methods has been able to halve patients waiting times.

Originally used for diagnosing HIV across Africa, SAMBA II machines were deployed in the ED and holding wards at Addenbrooke’s hospital to help detect COVID-19 in patients as part of a research trial called COVIDx.

Researchers investigated whether using the new machines could accurately provide a faster diagnosis than standard testing practices and review how it would affect patient waiting times.

After collecting nose and throat swabs from over 140 patients, the samples were processed using the SAMBA II machine. Researchers found they were able to provide an accurate diagnostic result within 90 minutes, compared to the standard 24-48-hour lab waiting time.

Researchers also reviewed the length of time patients spent in on the ‘holding’ ward before they were admitted to the hospital or discharged. They compared the electronic patents records of all those who had in-hospital tests done in the 10 days before and then after the switch to diagnosis by SAMBA II machines at the hospital.

They found waiting times halved from 58.5 hours to 30 hours and saw a fall in the use of single-occupancy ‘isolation’ rooms in which COVID-19 patients are ideally treated, freeing up hospital beds.

With this new evidence, the hospital has switched most of their testing methods to the SAMBA II machines to diagnose patients with suspected COVID-19.

Professor Ravi Gupta from the Cambridge Institute for Therapeutic Immunology and Infectious Disease, who led the COVIDx study said: “Rapidly testing admissions for SARS-CoV-2 at the point of care is essential for reducing COVID-19 transmission in hospitals, speeding up access to urgent care and allowing safe discharge to care homes. Keeping surgical bays open means fewer cancelled operations and speeding up access to life-saving clinical intervention.”

Researcher, Dr Dami Collier said: “Our research demonstrates that point-of-care testing with SAMBA II machines is not only reliable, accurate and much faster, but that the diagnostic speed leads to significant real-world improvements for patient care and safety.”

CUH Medical Director, Dr Ashley Shaw, said: “Point of Care testing has been hugely beneficial in enabling our clinical teams to make well-informed and timely decisions, keeping patients and staff as safe as possible throughout this difficult period.”

The COVIDx study was supported by the NIHR Cambridge Biomedical Research Centre and NIHR Cambridge Clinical Research Facility.

Cambridgeshire Trusts join COVID-19 vaccine trial

June 3, 2020

Three leading NHS Trusts in Cambridgeshire are collaborating on a COVID-19 vaccine trial which has been developed by the University of Oxford.

The COV002 trial aims to assess how well people across a broad range of ages could be protected from COVID-19 using a new vaccine called ChAdOx1 nCoV-19. It will also provide valuable information on safety of the vaccine and its ability to generate good immune responses against the virus.

Cambridgeshire and Peterborough NHS Foundation Trust (CPFT), Cambridge University Hospitals NHS Foundation Trust and Royal Papworth Hospital NHS Foundation Trust are offering an opportunity for healthy staff who aged between 18-55 years old, who have not been infected with coronavirus but have regular face to face contact with COVID-19 patients, to take part in the trial. CPFT is the only integrated physical, mental health and social care NHS Trust in the UK offering the trial to staff across the region.

If they are eligible to take part in the study, participants will be randomised to receive one dose of either the trial vaccine (ChAdOx1 nCoV-19) or a licensed meningitis vaccine (MenACWY) that will be used as a ‘control’ for comparison. Screening of participants began on 29 May 2020 and following vaccination, participants will be followed up over 12 months.

Dr Estée Török, Honorary Consultant in Infectious Diseases and Microbiology and Principal Investigator at Cambridge University Hospitals NHS Foundation Trust, said: “Developing an effective vaccine is key to controlling the COVID-19 pandemic. We are delighted to be working with CPFT and RPH on this UK national priority vaccine trial. We are looking for healthy volunteers at high risk of COVID-19 infection at CUH to participate in this study and are most grateful to them for doing so.”

Dr Ben Underwood, Deputy Medical Director and Principal Investigator (study lead) at CPFT said: “We are grateful to all our staff for their brilliant response to the coronavirus pandemic. Our research teams are playing a vital role in international efforts to secure a vaccine, which we hope will protect those most at risk, save more lives and minimise the disruption caused by the virus. Thank you to all volunteers who take part and make clinical trials possible.”

Dr Robert Rintoul, Director, Papworth Trials Unit Collaboration, said: “We at Royal Papworth Hospital are proud to be supporting research into possible vaccines and treatments for COVID-19. I would like to thank our staff members who have chosen to participate in this important public health project.”

This study is funded and supported by the National Institute for Health Research and UK Research Innovation.

For further information on the trial visit the University of Oxford website.

Cambridge study to trial widely used drug to protect healthcare staff from COVID-19.

May 22, 2020

The PROLIFIC study (ChemoPROphyLaxIs For covId-19 infeCtious disease) aims to determine whether hydroxychloroquine (HCQ), a widely used anti-malarial drug, is effective at preventing or reducing COVID-19 infection in frontline healthcare workers.

Until a safe and effective vaccine is available to prevent SARS-CoV-2 infection and the development of COVID-19 symptoms, NHS and other frontline healthcare staff, including paramedics, will continue to remain vulnerable even with the best personal protective equipment (PPE) available. Chemoprophylaxis (drugs taken to prevent infection) may be an effective strategy for reducing infection in NHS staff until a successful vaccine can be produced.

Although HCQ and the related drug, chloroquine, have been suggested as potentially effective treatments for COVID-19 from early on in the pandemic, there have not yet been any well-designed, sufficiently large studies that can provide the evidence required for their use as preventative therapies. PROLIFIC is a randomised, double-blinded and placebo-controlled study that will determine whether daily or weekly doses of HCQ are effective at reducing COVID-19 infection among front-line health care workers.

HCQ, a medication already widely and safely used to prevent malaria in high risk countries has shown promise at preventing SARS-CoV-2 infection in vitro (in cells grown in a lab). Compared with chloroquine, HCQ causes fewer side effects, and has shown greater potential at preventing coronavirus infection in early studies, even when used at lower concentrations. How HCQ works to prevent infection is not fully understood, but researchers believe that it may block the virus from entering cells by influencing the pH in the part of the cell that would normally fuse with the virus to allow it to get inside the cell and replicate.

Dr Joseph Cheriyan, Consultant in Clinical Pharmacology at Cambridge University Hospitals, and Chief Investigator of the study said: “It is important that we quickly determine via a randomised controlled trial if HCQ provides a means to provide additional protection to frontline workers, this in turn will also protect the public. The PROLIFIC trial should provide answers shortly to address these issues.”

If this trial is successful, it will help to protect and maintain our skilled healthcare workforce, as well as reducing the burden of infection on an already strained healthcare system.

Professor Ian Wilkinson (Professor of Therapeutics and Director of the Cambridge Clinical Trials Unit) said: “Front-line heath care workers are like the spitfire pilots of the Battle of Britain. I am delighted that Cambridge is leading the way in testing hydroxychloroquine to protect health care workers from a disease that has already claimed the lives of too many people. PROLIFIC will be based exclusively in the UK and thus provide an answer directly relevant to the NHS and UK social care setting.”

PROLIFIC will be recruiting healthcare participants from hospitals and care homes across the country.

Find out more about the PROLIFIC trial and read the patient information sheet, or for further information visit the CCTU website.

Cambridge trial targets immune response to treat COVID-19 patients

May 16, 2020

A new national study, supported by the NIHR Cambridge Biomedical Research Centre and the Cambridge Clinical Trials Unit will test whether two drugs that are already in use to treat other immune-related conditions can prevent the development of severe COVID-19 infection.

The TACTIC-R trial (mulTiArm therapeutiC sTudy in pre-Icu patients admitted with Covid-19 – Repurposed drugs) will target patients as they are admitted to hospital, and test whether drugs that suppress the immune system can prevent the so-called ‘cytokine storm’ that is thought to lead to severe COVID-19 disease.

For the majority of people who have COVID-19, the infection causes only mild symptoms including a fever and cough. However, around 15% of patients develop severe disease, which includes serious damage to the lungs and multiple organ failure. This lung and organ damage appears to be mostly caused by the body’s own immune system responding to the presence of infected cells and ‘over-reacting’, destroying healthy cells as well as virus-infected ones. Researchers hope that preventing the immune ‘over-reaction’ using drugs that stop or ‘suppress’ the immune response will stop patients developing the severest form of COVID-19, preventing the need for intensive care.

Repurposing medicines to treat COVID-19

The immune system has several ways to attack viruses and other infections, and TACTIC will initially test two drugs that target different aspects of the immune response and are already in use to treat other conditions caused by an overactive immune system.

One of the first systems triggered when the immune system spots a pathogen (a bacteria or virus) is known as the complement system. Parts of the complement system are constantly circulating in the blood, ready to spot infections. When activated, it acts as a ‘first responder’ setting off a rapid chain of events that alerts the rest of the immune system and can label infected cells for destruction. Excessive activity by the complement system is thought to be responsible for the organ damage seen in COVID-19, and this trial will test a drug called ravulizumab that is usually used to treat a condition where the complement system destroys red blood cells.

The cells in the body that fight infection ‘talk’ to each other using tiny chemical messages known as cytokines. Different cytokines give different instructions to other immune cells, telling them to make more cytokines, multiply themselves to make more immune cells or to destroy other cells showing signs of infection. The right amount of the right cytokines gives the best immune response – but too much of the wrong cytokines causes inflammation that can damage healthy cells and tissues. This is known as a ‘cytokine storm’ and is thought to be another contributor to severe COVID-19 responses. The TACTIC trial aims to test whether baricitinib, a drug that is regularly used to ‘dial down’ excessive cytokines in people with rheumatoid arthritis, can effectively reduce the cytokine storm experienced by patients with severe COVID-19 symptoms.

Dr Frances Hall, Consultant Rheumatologist, Cambridge University Hospitals NHS Foundation Trust (CUH) and TACTIC Chief Investigator, explained: “With no proven treatments for Covid-19, the quickest route to a cure is through trying drugs already used for other illnesses that affect the body in a similar way. There is good reason to believe that these two drugs could help prevent severe organ failure and even death. I want to thank all of the patients taking part in this important trial – you have made a vital contribution to finding the solution to Covid-19.”

The two drugs that will be tested in TACTIC have been carefully selected by a consortium of doctors and scientists with expertise in treating immune-mediated diseases, and are thought to have a high chance of reducing the immune ‘over-reactions’ seen in very sick patients with COVID-19. However, the TACTIC trial has been designed so that if further drugs are identified that calm the immune response seen in these patients, they can easily and safely be tested in the study.

Similarly, if the trial shows evidence that a drug is not effective, it can quickly be removed so that other options can be tested. This is known as a ‘platform’ study, and will ensure that the knowledge that is gained through this study (whether the drugs are effective or not) is quickly adopted into medical care to improve outcomes for patients.

This trial will be delivered with support from our partners in the life sciences industry. This will enable drugs that treat COVID-19 to quickly and safely be tested through this study, so that any drugs that are shown to be effective can rapidly be licenced for use internationally. Partnering with Alexion for ravulizumab and Lilly for baricitinib will ensure that, if either is successful, production is ready to be scaled up to ensure that there is a suitable supply available to treat those who need it.

“We look forward to working with Cambridge University Hospitals NHS Foundation Trust to explore whether inhibiting complement with ravulizumab (Ultomiris) can help to reduce the progression to severe COVID-19 in high-risk hospitalised patients who do not yet require ventilatory support”, said John Orloff, M.D., Executive Vice-President and Head of Research and Development at Alexion. “This study will provide important controlled clinical data to determine whether earlier-stage treatment can reduce the severe organ damage associated with COVID-19 as well as the need for admission to the intensive care unit and use of ventilation.”

Dr Arash Tahbaz, Lilly Senior Medical Director for Northern Europe, said: “During this challenging time, Lilly is focused on ensuring a reliable supply of medicines, keeping our employees safe and pushing scientific efforts at top speed to defeat COVID-19. Supporting the TACTIC-R trial is one of the ways we are doing this and we are very pleased to be able to support the Cambridge team in their work to find effective treatments for COVID-19.”

Professor Ian Wilkinson, Director of the Cambridge Clinical Trials Unit, said: “This is a time of huge national effort in the fight against Coronavirus and I am delighted that Cambridge is playing a key role in this. TACTIC will test the effectiveness of a number of existing and new drugs in patients admitted to hospital with COVID-19, in a similar way to the RECOVERY trial, but with a strong focus on modulating the immune response and collecting high quality data that can be used by our partner pharmaceutical companies to seek the necessary approvals for widespread international use.”

Support

This study is one of a number of COVID-19 studies that have been given urgent public health research status by the Department of Health and Social Care.

This trial is being supported by the NIHR Cambridge BRC and NIHR Guy’s and St. Thomas’ BRC.

Over 150 participants recruited to new COVID-19 research programme

May 13, 2020

A “library” of valuable biological samples from people with COVID-19, which will help scientists globally fight the virus, has recruited its 150th participant.

The National Institute for Health Research (NIHR) BioResource began collecting samples at the end of March from patients admitted to Addenbrooke’s hospital with suspected COVID-19. Samples included blood, nasal and throat swabs, plus a mental and physical health questionnaire.

The biological samples are carefully separated, analysed and stored as part of a resource for scientists to draw upon when researching treatments, vaccinations or a deeper understanding of COVID-19.

The NIHR BioResource will now seek further participants to join the new NIHR COVID-19 BioResource cohort. All hospital patients in Addenbrooke’s and The Royal Papworth Hospital with suspected or confirmed COVID-19 are invited to take part in this essential research. NHS staff undergoing routine screening for the COVID-19 infection will also be invited to participate in the study.

Up until now, local samples have mainly been collected in Cambridge, and processed in a specialist lab in the Jeffrey Cheah Biomedical Centre. Over the next few weeks, local NIHR BioResource centres across England will be able to begin recruiting from other hospitals.

Sample collection

Since the initiative launched in March, the NIHR COVID-19 BioResource has collected samples from more than 150 participants, including patients with COVID-19 and NHS staff who are either asymptomatic or with mild symptoms who had been self-isolating at home as a precaution. Collection of samples from NHS staff in addition to patients allows the NIHR COVID-19 BioResource to safely collect samples from participants with the full range of symptoms experienced from COVID-19, while contributing to the essential COVID-19 screening of NHS staff.

Dr Nathalie Kingston, Director of the NIHR BioResource said: “Since the outbreak, leading experts across the world are coming together to collaborate in joint research projects to help slow down and halt the disease, the NIHR BioResource is no exception.

“Working with our current infrastructure, we have created a new resource where we can easily recruit patients who have been diagnosed with COVID-19 and clinical staff working in the NHS. We can then track the disease progression during the participant’s recovery as well as understand any changes to their mental health. We will then be able to harness and use the information for future research trials and improve our knowledge of the disease.

“We have a special interest in enrolling patients under 40 who are admitted to hospital, to better understand their immune response. We will also be working alongside paediatrics intensive care units across the country to enrol patients under the age of 16 and their parents.

“The NIHR COVID-19 BioResource doesn’t prevent anyone from taking part in other research studies for COVID-19. There are many national research studies taking place and we need as much information as possible if we are going to tackle this disease.”

How the NIHR BioResource helps research

The NIHR BioResource is a nationwide platform that supports research in a number of health conditions. It brings patients, as well as healthy volunteers, who want to take part in research together with researchers who need volunteers to take part in studies. Currently, there are over 150,000 people with or without conditions who have consented to be approached to participate in research.

The NIHR COVID-19 BioResource offers patients diagnosed with COVID-19 and clinical staff an opportunity to provide their biological samples for the purposes of research. Healthy volunteers are currently able to sign up without providing a sample but can consent to take part and will complete a health questionnaire. They will then be invited to provide their sample at a later date when restrictions are lifted and when it is safe to do so.

Researchers will use the information to support current and future research into understanding the disease, including finding new treatments and why some people experience mild symptoms but others are more serious.

Principle Investigator Professor Ken Smith from the Cambridge Institute of Therapeutic Immunology and Infectious Disease will be analysing the samples collected from Cambridge to understand how the immune responds to the virus.

Professor Smith said: “By understanding more about participants’ immune response to the virus, we hope to find out why some people get severe, and indeed life-threatening, COVID-19 while others have very mild symptoms or no symptoms at all.

“This information will help in the development of effective vaccines and may help doctors to identify people who are more at risk of severe symptoms before they are infected.”

Dr Michael Weekes, Honorary Consultant in infectious diseases, whose primary research focuses on how our cells defend themselves from viruses, is trying to identify people most at risk of severe COVID-19. Dr Weekes said: “We have been studying blood samples from participants of the NIHR COVID-19 BioResource for use with a technique called ‘proteomics’.

“This is where we analyse which proteins are present on the surface of white blood cells from patients with severe or milder forms of COVID-19. This will help us determine when a patient is admitted to hospital with COVID-19 if it is likely they will need to be treated in the intensive care unit.

“We are also looking at healthcare workers who have experienced mild symptoms of COVID-19, or even who have had the virus without any symptoms at all. Staff who have signed up to the NIHR COVID-19 BioResource have provided a small sample of blood to be analysed. This research will help us understand how our body defends itself against the virus, and identify who is most at risk of developing severe COVID-19.”

Take part without being an inpatient

People who have had mild COVID-19 symptoms or have not been affected with the virus can still get involved in research. Currently, there is no way of safely collecting biological samples from a non-hospital setting. However, people can still contact the NIHR BioResource to volunteer for research in other ways, such as taking surveys.

The NIHR COVID-19 BioResource is encouraging more participants who have been hospitalised with COVID-19 to sign up to the research programme. The more samples collected, the more chance researchers can understand the disease and discover new treatments. www.bioresource.nihr.ac.uk

NIHR Cambridge BRC and CRF begin working on new COVID-19 study

April 17, 2020

Research staff from NIHR Cambridge Clinical Research Facility (CRF) are being deployed onto the wards at Cambridge University Hospitals (CUH) to start using a new test for a research trial into COVID-19.

COVIDx, a study supported by the NIHR Cambridge BRC, aims to investigate the impact of two new tests for COVID-19 on delivering faster diagnoses and understanding the development of immunity following infection. The first part of the study will evaluate the accuracy of the new SAMBA II-based test and whether it speeds up the diagnosis of COVID-19 in a ‘real-time’ hospital setting at the point of care.

The second part will investigate a point of care finger prick ‘antibody’ test of the blood, to determine how quickly markers of immunity appear following infection and a positive SAMBA test. These antibody tests will be important for understanding which patients and staff have already had the infection, and may be safe to return to work following recovery.

Research nurses detecting COVID-19

Research nurses working with the SAMBA II machines

Research nurses from the NIHR Cambridge CRF are collecting samples from patients with suspected COVID-19 to support the COVIDx study. Vivien Mendoza, NIHR Cambridge CRF lead research nurse said: “Our research nurses are working on a triage ward at CUH dedicated for patients who may have COVID-19.

“We are using the SAMBA II machine to test nasal and throat swabs to determine if a patient has COVID-19 and if the new device is an improved source of testing. The new test only takes 90 minutes and we will be matching these swabs against the results of standard practices.”

Currently, swabs taken from patients are sent off to the lab to be analysed, which can take a few days to return a result. The SAMBA II test can provide extremely reliable results in less than two hours, meaning decisions about clinical care or self-isolation can be made much more rapidly. The antibody tests require serum from blood samples, which will be tested in specialised facilities at the Cambridge Institute for Therapeutic Immunology and Infectious Diseases (CITIID).

Vivien added: “SAMBA II produces a summary of the test and the results are sent to a tablet and can be forwarded on to the clinician. When the clinicians receive the results they are able to start the correct care pathway for the patient a lot faster. We will also be testing NHS staff members who are working in COVID-19 wards and ITUs.”

The new test will help those who may have been infected and those who are displaying non-specific symptoms (such as from hay fever or the common cold) return to work. This will avoid healthy staff going into self-isolation, supporting the delivery of front-line care.

Caroline Saunders, Director of Clinical Operations for NIHR Cambridge CRF said: “Research is vital in finding new treatments and testing new devices, COVID-19 shows exactly what our staff are trained for. Our nurses have tremendous experience and expertise in trialling new devices and treatments across a wide range of specialties and age ranges and have the skills to adapt to these new challenges.”

Testing patients and staff

Patients who are admitted to Cambridge University Hospitals and have suspected COVID-19 will be given the opportunity to take part in the COVIDx research trial, providing swabs and blood samples. They will also be given the opportunity to enrol in other COVID-19 related trials such as the RECOVERY study, currently on going at the hospital.

Once the two diagnostic tests have been validated in patients with confirmed COVID-19, the study will enrol a second group of participants – healthcare workers. The SAMBA II test will be able to quickly identify staff who are positive for COVID-19, even if they have no symptoms, allowing them to self-isolate or access treatment if required. The antibody test will be able to identify staff who have already had the infection, which will support frontline NHS staff over the epidemic.

Professor Ravi Gupta from the Cambridge Institute for Therapeutic Immunology and Infectious Disease, who is leading the COVIDx study said: “Like all new medicines, new tests and devices need to be assessed for their strengths and weaknesses. COVIDx is a month-long trial at CUH which will give us an opportunity to evaluate two new forms of point of care testing for COVID-19 in ‘real life’.

“By comparing 200 patient samples to the new screening tool, we will be looking at whether the new tests are faster and are more reliable than the existing practices. If we can prove the new test can provide a diagnosis in a fraction of the current waiting time, then we are able to triage patients to the right part of the hospital earlier and start their care a lot sooner.

“We are beginning to test staff in high-risk areas to help reduce the risk of infection and stop staff having to go into self-isolation unnecessarily. It is really important we can ramp up tests for everyone to make sure we can minimise the risk of infection and have better patient outcomes.”

Further information on SAMBA II

The technology behind SAMBA II was developed while Dr Helen Lee was at Cambridge’s Department of Haematology. The development of the technology has been supported by Wellcome, the Children’s Investment Fund Foundation, the US National Institutes of Health and Cambridge Enterprise, among others. For more information see the University of Cambridge press release

The SAMBA II has been initially rolled out at CUH before being launched in hospitals nationwide to test patients, and staff working in high-risk areas or intensive care units.

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