On 31 December 2019, the World Health Organisation (WHO) received the first reports of a previously unknown virus in the city of Wuhan, China. In the months since, the respiratory illness that we have come to know as coronavirus COVID-19 has become a global pandemic with the disease being detected in over 196 countries and territories, with the most widespread outbreaks outside of China being in Italy, the US and Spain. Globally, there have been 473,308 cases of coronavirus and 21,344 deaths, while in the UK there have now been 9,529 confirmed cases and 465 deaths (as at 9am on 26 March 2020).

With COVID-19, caused by the SARS-CoV-2 virus, having rapidly become a global pandemic the need to develop treatments to prevent and effectively treat the virus is extremely urgent. As confirmed cases continue to grow and national health systems strain under the pressure, researchers, funding bodies and innovators are working to repurpose existing drugs, develop vaccines, identify novel antibody approaches and develop digital health technologies.

The UK Government has called for support from businesses to help make NHS ventilators and for medically-trained academics to be released from research responsibilities to support the NHS, while providing SMEs with support to accelerate research and innovation.

Right now, MedCity’s eco-system is playing a vital role in providing the ‘solution’ to health and research in response to COVID-19 and in tackling this global pandemic.

Vaccine development

As the response to the COVID-19 outbreak unfolds, BioCentury is tracking new vaccines and therapeutics in development against the coronavirus. Key players in vaccine development include CureVac, Sanofi, GSK and Inovio, with US-based Moderna being the first to hold a Phase 1 study.

Imperial College London and University of Oxford are two UK universities driving forward development programmes in the global race for new COVID-19 vaccines. Scientists at Imperial College London state that they are on the verge of developing a vaccine, having already successfully tested the treatment on mice and may be able to start human trials by June. Meanwhile The Jenner Institute at the University of Oxford is also preparing to start clinical testing of a novel coronavirus vaccine candidate, and scaling up the vaccine ready for larger trials, and potentially, future deployment.

Open Orphan PLC’s hVIVO virology and vaccine operation has also made significant advances having started the world’s first human coronavirus challenge study. Also known as a controlled human infection model, at its simplest, it is a method of testing potential vaccines against certain illnesses in a locked-down medical facility. A spinout from Queen Mary University of London, hVIVO owns Europe’s only quarantine clinic with an onsite virology lab where the challenge model will be developed and used.

The UK is also working to develop antivirals to prevent or limit infection when given before or shortly after exposure, before illness occurs. Southampton-based biotech Synairgen is soon to begin a COVID-19 trial of lead candidate SNG001 following fast-tracked approvals from the Medicines and Healthcare products Regulatory Agency (MHRA) and Health Research Authority (HRA). The drug was developed to prevent severe lower respiratory tract illness caused by infections and was identified in a World Health Organization analysis as the only phase-two therapy that is inhaled, which means patients can self-administer it.

Gilead has developed the most promising antiviral so far, which is in phase 3 trials in China and phase 1 trials in the USA. They have temporarily stopped granting patients across the US, Europe and Japan with emergency access to remdesivir due to an “exponential increase” in requests.

Images by Thomas Angus © Imperial College London

Epidemiological research

London universities and research institutions have been studying epidemiological data to guide situational awareness and intervention strategies. Here, Imperial researchers are leading the global fight, revealing the first accurate estimates of the size of the outbreak, tracking how the virus affects the body and immune system, and spear-heading efforts to understand how this virus spreads.

Imperial College London research has played a pivotal role in informing government strategy, prompting the UK government to rethink its strategy against the COVID-19 outbreak. In the week commencing 16 March, Prime Minister Boris Johnson called on UK citizens to avoid non-essential contact and to avoid public spaces. The Imperial report used epidemiological modelling to predict outcomes of different combinations of containment strategies. The results showed the UK should supplement its self-isolation measures by school and university closures.

This week, it was a collaboration between UCL, the University of Cambridge and Health Data Research UK that provided critical insight into the implications of the latest UK government strategy, revealing that its efforts to slow the coronavirus epidemic could lead to between 35,000 and 70,000 excess deaths over the next year. The study estimates the excess number of deaths in relation to underlying medical conditions and age, using NHS health records from 3.8m adults in England. On the back of their research, the team called on the government to enforce lockdowns or social distancing in place of voluntary measures.

The MRC Centre for Global Infectious Disease Analysis has also been a crucial information source feeding into national plans for dealing with the coronavirus. As we moved from a containment phase in the UK to a delay phase and potential mitigation, they produced detailed scenarios of what might happen to inform healthcare planning.

A systematic review and meta-analysis from University College London was also critical insight which informed public health and clinical management strategies, and prioritised those at highest-risk of severe illness with COVID-19. Their findings showed that patients presenting shortness of breath and chronic obstructive pulmonary disease (COPD) are the most likely to have severe COVID-19 and need admission into intensive care units.

Following an outbreak of COVID-19 on cruise ship Diamond Princess in which 617 of 3700 people were infected, a team at London School of Hygiene and Tropical Medicine (LSHTM) applied mathematical models to estimate the basic reproduction number under cruise ship conditions. The research estimated that if everyone had carried on as normal then 2,920 people would have been infected. However, if passengers had been evacuated when the outbreak was first detected, only 76 people would have been infected. Thus research evidenced the critical importance of evacuation happening quickly, and full quarantine being essential.

Researchers at the Crick are currently investigating how the virus interacts with and replicates within human cells, and how the virus was transmitted from animals to people. This work is seeing collaboration across virologists, geneticists, immunologists and bioinformaticians at the Crick as they pool their expertise in their mission to expose the virus’ weaknesses and guide the development of potential treatments or vaccines. In collaboration with scientists at The Roslin Institute, the lab will draw on innovation, using CRISPR technologies to discover the genes that are involved.

Public Health

Universities and research institutions in the region are supporting the fight against the outbreak by releasing employees from their duties, including University College London who are allowing medically-trained researchers to volunteer in the NHS, and over 300 scientists at The Francis Crick Institute who are carrying out essential diagnostic tests in the lab.

As well as providing public health guidelines, Public Health England scientists are also playing a critical role in international efforts to trace the source of the virus, how it has developed and interventions to help treat it. The team has been awarded $500,000 by the FDA to bolster the international response to coronavirus vaccine and treatment development.

The Wellcome Sanger Institute is collaborating with the NHS, public health agencies and academic institutions to analyse the genetic code of COVID-19 samples circulating in the UK, providing public health agencies with a unique tool to combat the virus. The Covid-19 Genomics UK Consortium project aims to track the spread of the coronavirus in the UK and watch for emerging mutations using gene sequencing to analyse the strains.

LSHTM has developed an Outbreak Tracker that allows you to scroll through a timeline for nCoV, SARS, H1N1 and Ebola. Adam Kucharski, an epidemiologist at LSHTM, has also been speaking in the media around the dangers of spreading misinformation on the coronavirus. He sought to remind of the importance of ensuring the public has the best possible health information during an outbreak because, at best, misinformation can distract from important messages, and at worst, it can lead to behaviour that amplifies disease transmission.

© Babylon

Digital Health

The outbreak has created opportunities for digital health innovators to contribute to more effective healthcare delivery, with the immediate need for secure and effective telemedicine, remote monitoring, digital therapeutics, AI analytics, and automation of clinical care pathways. There is a shift in healthcare delivery as it moves quickly to address social distancing, reduced staff capacity, support for those with mental health and chronic conditions, and facilities for testing.

Much of the innovation has centred on how the NHS can meet a surge in demand for digital services brought on by COVID-19, both for enabling doctors to continue seeing patients amid the outbreak, as well as to support those involved in the delivery of healthcare in communicating and collaborating around their responses.

Established video consultation apps are helping people to communicate with healthcare workers, such as Babylon Health who have launched a COVID-19 Care Assistant to advise people how to diagnose and manage suspected COVID-19 infections. .

A COVID Symptom Tracker designed by doctors and scientists at King’s College London and Guys and St Thomas’ Hospitals working in partnership with ZOE Global Ltd – a health science company – was recently launched to track progression of the disease in real time. This comes off the back of news that NHSX is developing a contact tracking app to monitor the spread of coronavirus. 

London-based GoodSAM platform is powering the on boarding and deployment of the Volunteers for the NHS and RVS during the Coronavirus crisis. Once someone has registered and checks are complete they will be provided a log-in to the GoodSAM Responder app where they see live and local volunteer tasks to pick from nearby.

Rakesh Uppal, Director of Barts Life Sciences and Professor of Cardiovascular Surgery

“This outbreak has prompted us to make moves towards video-consultations quicker than expected. This is the most important use for health technology in my eyes, as humans we want to be able to see a real person to discuss our concerns.

“We are about to see a fundamental change in how the NHS interacts with patients and the digital health agenda will really accelerate. In certain specialisms, we are seeing a move to more smart devices to monitor blood pressure, remote managing of conditions such as diabetes and heart disease, and automation of clinical pathways.

“Unfortunately, I don’t think tech infrastructure is up to scratch yet, but this has been the impetus for us to look at what we can achieve in all aspects of digital health, drug discovery, material science, and public health, to prepare for the future.”

To ensure that digital health technologies can be reviewed and commissioned by the NHS as quickly as possible, NHSX is consulting on a draft Digital Health Technologies Standard. This consolidates existing standards and aims to help developers understand what’s expected of them. You can take a look at the draft standard and complete a short survey to ensure a robust, proportionate and attainable standard. Due to the outbreak and a shift in NHS priorities, this consultation will remain open past the initial deadline of 22 April.

Funding Opportunities

Opportunities are arising for researchers and innovators to accelerate and evaluate new drugs, vaccines and biologics in the short term, and viral pathogens in the long-term, including:

  • LifeArc opened a £10m fund on COVID-19 for the development and testing of therapeutics that can be rapidly deployed to treat COVID-19.
  • European Commission has secured €47.5 million for urgently needed research on COVID-19 vaccine development, treatment and diagnostics.
  • Wellcome joined the Bill & Melinda Gates Foundation, Novartis and Mastercard in launching a new initiative to speed the development of and access to therapies for COVID-19. Together they are committing up to $125 million in seed funding.
  • Horizon 2020 Open Call: Development of therapeutics & diagnostics combating coronavirus infections
  • NHSX call for innovators who can support the elderly, vulnerable and self-isolating

You can find more details here

Support

Alongside MedCity, advice and support for researchers and innovators is available from national life sciences and healthcare bodies.

ABHI is guiding the HealthTech community to support the national effort to provide life-saving health technologies to patients

https://www.abhi.org.uk/resource-hub/file/9623

ABPI is working closely with the Department of Health and the NHS on how its members can best support the Government as plans evolve

https://www.abpi.org.uk/medicine-discovery/covid-19/

BioIndustry Association, the trade association for innovative life sciences in the UK, has set up a dedicated page of advice

https://www.biacovid19.org/

Innovate UK , on the support available to businesses due to COVID-19 and advice for award holders

https://www.gov.uk/government/news/innovate-uk-covid-19-business-support

KTN is working with Innovate UK and other organisations to connect those able to respond or adapt to the UK’s new challenges

https://ktn-uk.co.uk/perspectives/covid-19-response-from-ktn

MHRA is prioritising work supporting and authorising the development of vaccines, clinical trials of new medicines and managing the supply of medicines and healthcare products.

MHRA Clinical trials helpline: Clintrialhelpline@mhra.gov.uk

https://www.gov.uk/government/collections/mhra-guidance-on-coronavirus-covid-19

NHS Health Research Authority is providing CV-19 guidance for sponsors, sites and researchers

https://www.hra.nhs.uk/planning-and-improving-research/policies-standards-legislation/covid-19-guidance-sponsors-sites-and-researchers/

NICE has developed rapid guidelines and evidence reviews

https://www.nice.org.uk/covid-19

Public Health England has a list of guidance for health professionals and industry, including the evaluation of commercially available diagnostic products

https://www.gov.uk/government/publications/covid-19-evaluation-of-commercially-available-diagnostic-products

UKRI is providing information and guidance on the impact of coronavirus on UKRI-supported research

https://www.ukri.org/news/coronavirus-impact-on-ukri-supported-research/

Hotlines:

Vaccines: nervtag@phe.gov.uk

Ventilators: ventilator.support@beis.gov.uk

Innovation/Tech: DNHS@nhsx.nhs.uk

Increasing testing and diagnostic capacity: Coviddiagnostics@phe.gov.uk