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University Hospitals Dorset NHS Foundation Trust

COVID-19 Research

Working closely with our clinical colleagues the Royal Bournemouth Hospital research team is delivering high priority COVID-19 studies. In doing so we are contributing to the national and international effort to diagnose, treat and ultimately prevent the disease. This is already having an impact on patient care and other responses to the pandemic.

Vaccination is a key part of the global strategy to tackle the pandemic. Rigorous trials are essential to ensure vaccines are safe and effective. UHD played its part in this search, recruiting over 500 participants from across Wessex to the Novovax Covid-19 vaccine trial at the new Dorset Research Hub located at the Royal Bournemouth Hospital. We are delighted to hear that interim analysis of the UK Phase 3 trial has shown 89.3% efficacy, including against the UK variant strain. An innovative collaboration between local NHS providers, CCGs and the National Institute for Health Research (NIHR) was central to successfully delivering the study in the region.

We are continuing to use this model in two studies investigating AstraZeneca's long-acting antibody (LAAB) combination called AZD7442. Antibodies are protein molecules that the body produces to help fight infections. Monoclonal antibodies are artificially produced in a laboratory and designed as possible medical treatments and can be injected directly into the body, unlike vaccines which encourage the immune system to produce antibodies. The antibodies have been engineered to last for six to 12 months from one dose, and the combination of two is designed to reduce the risk of resistance developed by the SARS-CoV-2 virus.

In both studies, researchers are assessing whether the treatment reduces the risk of developing COVID-19 and/or reduces the severity of infection compared to placebo. PROVENT is enrolling adults who are either unable to take the vaccine, at increased risk of inadequate response to vaccination due to age, or increased risk of COVID-19 infection (e.g. healthcare and care home staff, students in halls). STORM CHASER focuses on the latter group where they have been in close contact with a confirmed Covid-19 case within the past eight days, a setting where vaccination would not have time to work. So far the Hub has recruited 71 participants to PROVENT and 1 to STORM CHASER.

Effective treatments once infection has developed are still vitally important, particularly during vaccine roll-out. The RECOVERY (Randomised Evaluation of COVID-19 Therapy) trial randomly allocates patients between several treatments, given in addition to the hospital's usual standard of care. As of 1st February 2021 The Royal Bournemouth Hospital has recruited 292 patients to the trial. Overall recruitment stands at 37561 from 179 'sites'.

The trial has rapidly produced results of international importance. Dexamethasone, a drug that was not initially recommended, reduces the risk of death by about one-third among patients receiving ventilation and by one-fifth in those requiring oxygen alone. In contrast neither hydroxychloroquine, lopinavir-ritonavir, azithromycin nor convalescent plasma improve survival in patients admitted to hospital with COVID-19.

Another drug under investigation in the trial is tocilzumab, an anti-inflammatory treatment usually given by injection for arthritis. This was also being evaluated in REMAP-CAP, a Randomized, Embedded, Multifactorial Adaptive Platform trial for Community-Acquired Pneumonia. This is a critical care study running in 12 countries worldwide, using an innovative trial design to efficiently evaluate multiple interventions simultaneously. On 7th January 2021, in analysis that has not yet been peer reviewed, the study published results showing tocilizumab (and likely another sarilumab) both reduce the relative risk of death by 24% (from 35.8% to 27.3%) and reduced the time spent in intensive care by 7 to 10 days for patients requiring respiratory support when given with 24 hours of admission to ICU. This is in addition to corticosteroids such as dexamethasone, and with supplies of tocilizumab already in UK hospitals both are now recommended for such patients as standard treatment. As study population of the RECOVERY trial differs (it includes patients outside of intensive care), this arm of the trial remained open until 24th January 2021 when sufficient patients were enrolled to establish whether or not tocilizumab had a meaningful benefit. Analysis yet to be peer reviewed shows there was an absolute difference of 4% in the number of deaths in the tocilizumab and usual-care groups. Meaning for every 25 patients treated with tocilizumab, one additional life would be saved. Tocilizumab also increased the probability of discharge alive within 28 days from 47% to 54%, and among patients not on invasive mechanical ventilation when entered into the trial significantly reduced the chance of progressing to invasive mechanical ventilation or death from 38% to 33%. The benefits of tocilizumab were clearly seen to be in addition to those of steroids - 82% of patients were taking a systemic steroid such as dexamethasone as standard-of-care. The data suggest that in COVID-19 patients with hypoxia (requiring oxygen) and significant inflammation, treatment with the combination of a systemic corticosteroid (such as dexamethasone) plus tocilizumab reduces mortality by about one third for patients requiring simple oxygen and nearly one half for those requiring invasive mechanical ventilation.

In addition the following treatments are still under evaluation:

  • Regeneron's 'anti-viral antibody cocktail' REGN-COV2 (a combination of monoclonal antibodies directed against coronavirus)

  • Aspirin (commonly used to thin the blood) - Patients with COVID-19 are at higher risk of blood clots forming in their blood vessels. Platelets, small cell fragments in the blood that stop bleeding, seem to be hyperreactive in COVID-19 and may be involved in the clotting complications. Since aspirin is an antiplatelet agent, it may reduce the risk of blood clots in patients with COVID-19.

  • Colchicine (a commonly used anti-inflammatory drug) - Inflammation (caused by an over-active immune system) is a key component of severe COVID-19, and can lead to lung damage, the need for mechanical ventilation, and death. Colchicine has a wide range of anti-inflammatory effects and has been used for centuries to treat gout and, more recently, other inflammatory conditions.

  • Baricitinib (an anti-inflammatory treatment for rheumatoid arthritis) - baricitinib may block the signalling activity of cytokine molecules which contribute to the hyper-inflammatory state seen in severe COVID-19 and may also have some anti-viral activity. There is some clinical trial evidence that baricitinib may be beneficial against COVID-19. The Adaptive Covid-19 Treatment Trial (ACTT-2), involving over 1,000 patients with moderate to severe COVID-19, tested remdesivir with baricitinib or a placebo. This concluded that baricitinib with remdesivir was superior to remdesivir alone in reducing recovery time and accelerating improvement in clinical status, particularly in patients receiving oxygen or non-invasive ventilation. Although the survival rate was better in the baricitinib treated group, the numbers were too small to provide a clear answer. The ACTT-2 trial did not look at the effect of baricitinib in addition to corticosteroids (steroids), which is now standard of care for severe COVID-19 worldwide.

The team is taking part in further studies to see if existing treatments for other conditions or diseases or new drugs may be used to treat people with COVID-19.

Interferon beta ('IFN-beta') is part of the body's first line of defence against viruses. There is growing evidence that deficiency in IFN-beta production by the lung could explain 'at-risk' patient groups enhanced susceptibility to developing severe disease during respiratory viral infections such as SARS-CoV-2. Furthermore, SARS-CoV-2 seem to suppress its production as part of its strategy to evade our immune systems. Synairgen’s SNG001 is a formulation of IFN-beta-1a for direct delivery to the lungs via nebulisation. Phase I and II trial data have shown that SNG001 activates lung antiviral defences and has been well tolerated in approximately 280 asthma/COPD/COVID-19 patients to-date. The Royal Bournemouth Hospital is participating in SPRINTER (SG018) a placebo-controlled phase III trial of SNG001 who are hospitalised due to COVID-19 and require standard oxygen therapy. 12 patients have been enrolled so far.

In addition to these 'interventional' studies we are taking part in a range of other research to improve the understanding of COVID-19 and its impacts. With so much still to learn about the disease, this range of perspectives is important to help ensure that decisions are informed by robust evidence wherever possible.

  • SIREN - Sarscov2 Immunity & REinfection EvaluatioN - A Public Health England study aiming to determine if prior SARS-CoV-2 infection protects people from re-infection. The study is will now also collecting data on vaccine effectiveness in the UK to inform national policy. Up to 100,000 individuals who work in a clinical setting where patients are present will be studied for at least a year. Nose and throat swabs and blood samples will be taken regularly to determine new acute infections and measure their antibody response and participants will complete a questionnaire to collect information on exposure and symptoms. This has been a team effort working collaboratively with Poole and other hospitals have been in touch to find out how we have delivered the study. Bournemouth has recruited over its target with 147 participants in 7 months. Overall the trial has recruited over 40,000 participants. Public Health England's first report from the study found:
    • Antibodies from past COVID-19 infection provide 83% protection against reinfection for at least 5 months;

    • Reinfections in people with antibodies were rare – experts identified 44 potential reinfections among 6,614 participants who showed evidence of previous infection;

    • However, early evidence also suggests a small number of people with antibodies may still be able to carry and transmit COVID-19.

    • Public Health England continues to stress the importance of following the stay at home rules and remembering hands, face, space - whether you have had the virus or not.

    A second report has now been released with early data showing a 'promising impact on infection in healthcare workers aged under 65' from the Pfizer-BioNTech vaccine. These preliminary results found one dose reduces the risk of catching infection by more than 70%, rising to 85% after the second dose.

  • GENOMICC - Genetics Of Mortality In Critical Care - This global study collects DNA samples from the critically ill patients to understand how our genes influence susceptibility to severe infections. In partnership Genomics England, Illumina and the NHS, the study is now sequencing the genomes of thousands of patients severely ill with coronavirus. This data, from the person's own genome, is linked to virus genome data provided by the COVID-19 Genomics UK (COG-UK) Consortium. In 2020 Bournemouth was one of the top 20 recruiting hospitals and so far has recruited 31 patients to the study, a significant contribution to the UK total of 11100. Initial analysis of samples and data from coronavirus patients has identified 'new and highly plausible genetic associations with critical illness in Covid-19' which can be targeted using existing treatments. This analysis used genomes collected in national studies prior to the pandemic as comparison. The study are now looking for 15,000 volunteers from across the UK who have tested positive for coronavirus but were not hospitalised to better understand the differences. Individuals will be matched based on other factors that are known to affect COVID-19 severity, and are particularly looking for older (68+) people or those from minority ethnic background.

  • CLARITY IBD - ImpaCt of BioLogic and Immunomodulatory TherApy on SARS-CoV-2 Infection and ImmuniTY in Patients with Inflammatory Bowel Disease - Patients with inflammatory bowel disease (IBD) are usually treated with immunosuppressive drugs. By inhibiting the immune system, these drugs increase the risk of serious infections and prevent vaccines fully working. We don’t yet know if these drugs increase the risk of COVID-19 infection, its severity or reduce immunity that usually follows infection or vaccination. As a precaution the UK Government advised patients taking these medicines to shield during the 12-week lockdown. This study is investigating the impact of specific drugs and shielding on COVID-19 infection and subsequent immunity. Participants are asked to complete a questionnaire and give a blood sample to be tested for evidence of past SARS-CoV-2 infection. The questionnaire asks about past or current symptoms of possible coronavirus infection and whether the patient has been shielding. If the test is positive the patient is asked will be asked to repeat the blood sample and questionnaire up to 5 times over the next 40 weeks. The results of this study will help inform public health policy decisions for patients with IBD as well as millions of other UK patients treated with immunosuppressive drugs. The team at Royal Bournemouth Hospital recruited 106 out of a total 7224 participants, the 23rd highest in the UK.

The following observational studies collect information from the hospital records of patients admitted with COVID-19 to answer the urgent questions. In order to obtain as much information as possible, and ensure the whole patient population is represented, data is collected for all patients unless they choose to opt out.

The Trust is also taking part in these following research projects asking valuable questions about how COVID-19 affects and interacts with other conditions, and how delivery of care has been affected.

Psychological impact of the Coronavirus (COVID-19) pandemic and experience: An international survey - Researchers from a collaboration group asked people to complete a short questionnaire to help better understand how the coronavirus is affecting us all and its impact on our day to day lifestyle. They hope to find out what is helpful for people during this time and also what may be causing some people to be affected more than others in terms of their wellbeing.

In the first phase of the study 28,000 responses were received, of which Bournemouth contributed 491! The second phase of the study, exploring how people have adapted or changed, is now open. Follow the link above or click here, you do not need to have participated in the first phase.

UK Coronavirus Cancer Monitoring Project. Patients with cancer potentially have greater susceptibility to COVID-19 and more serious complications of the disease. This could be both due to the cancer itself and treatment, with differences between different cancer type. Doctors and patients are having to make difficult decisions regarding their condition including whether or not to treat and if so what treatment and how it is given. It is important that these are informed by the best available evidence. UKCCMP aims 'to collect identify and learn from every case of COVID-19' and provide 'live' updates.

COVER Study - COvid-19 Vascular sERvice Study - The COVER study is a three-tiered project aiming to understand and evaluate the evolving impact of the COVID-19 pandemic on vascular surgery service provision, condition management and the effect on outcomes for those patients presenting and managed during the pandemic.

PACE - The impact of COVID-19 on patients with AML undergoing chemotherapy: an epidemiological study - It is known that patients with underlying health conditions are more likely to develop severe COVID-19 but many patients, including patients with Acute Myeloid Leukaemia (AML), cannot wait for treatment for their disease. Unfortunately both AML and the standard intensive or non-intensive chemotherapy options make these patients more likely to pick up infections. This observational study will recruit 100 patients with AML who are receiving, or due to receive, treatment with chemotherapy, at Bournemouth we have recruited 1 so far. The main aims of this study are to record how many of these patients have had COVID-19 previously, have an active infection or go on to develop COVID-19 whilst receiving treatment for their AML.

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