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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 to the Novovax Covid-19 vaccine trial at the new Dorset Research Hub located at the Royal Bournemouth Hospital. This saw innovative collaborative working between local NHS providers, CCGs and the National Institute for Health Research (NIHR).

Effective treatments 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 11th January 2020 The Royal Bournemouth Hospital has recruited 198 patients to the trial. Overall recruitment stands at 26102 from 176 '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 hydroxychloroquine and lopinavir-ritonavir and azithromycin - treatments recommended by some due to their activity in other viral infections - do not improve survival.

Commenting on the latter Professor Fiona Watt, Executive Chair of the Medical Research Council, said 'Although it is disappointing that azithromycin isn't an effective treatment for hospitalised COVID-19 patients, negative results are important so that clinicians can focus patient care on drugs that have been shown to work. This is particularly vital for antibiotics like azithromycin, because inappropriate use of antibiotics contributes to bacteria in the body becoming resistant.'

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. Having analysed these results and those from other published studies and the data collected in the trial so far (over double the patients from the others combined), the RECOVERY trial will continue to assess its effectiveness in wider patient groups (outside of intensive care).

In addition the following treatments are still under evaluation:

• Convalescent plasma (collected from donors who have recovered from COVID-19 and contains antibodies against the SARS-CoV-2 virus)


• 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.

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 a 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 will be participating in SPRINTER (SG018) a placebo-controlled phase III trial of SNG001 who are hospitalised due to COVID-19 and require standard oxygen therapy.

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 144 participants in 6 months. Overall the trial has recruited over 40,000 participants. Public Health England has now released their first report from the study finding:
  • 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.
  
  SIREN study leaders are clear this first report provides no evidence towards the antibody or other immune responses from COVID-19 vaccines, nor should any conclusions to be drawn on their effectiveness. The SIREN study will consider vaccine responses later this year.


• 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 contributiuon to the UK total of 7938. 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.

• ISARIC/WHO-CCP UK - ISARIC/WHO Clinical Characterisation Protocol for Severe Emerging Infections in the UK. This originated in 2013, the time of the SARS-CoV pandemic. It is part of an international collaboration (ISARIC/WHO-CCP) designed to collect information on severe emerging infections. The study was activated by the CMO in January 2020 in response to COVID-19 and has been collecting data and samples since the first cases were reported in the UK. This is a vital source of information for SAGE and has seen produced a wide range of impactful publications, most recently a simple, robust and clinically useful prognostic scoring system for adult hospital patients. At RBH we are contributing to the COVID19 Clinical Information Network (CO-CIN), the data collection tier and have recruited 366 (out of a UK total 142,655) participants so far.


• PRIEST - Pandemic Respiratory Infection Emergency System Triage study - This study was designed in preparation for a potential pandemic, allowing data to be collected from the early phases of the pandemic. The baseline characteristics and outcomes of patients with suspected COVID-19 using the emergency care system (999 or ED) are being used evaluate triage methods used to determine whether a patient with suspected coronavirus should be admitted to hospital, and if so to intensive care. The study has now completed enrolment and with Bournemouth contributing 352 patients to the total of over 22,000. The team have now complete analysis evaluating the prognostic accuracy of existing emergency department triage tools for adults with suspected COVID-19, in addition to developing a new tool.

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.