COVID-19: Keep up to date with the latest pharmaceutical and healthcare news as the pandemic evolves

 

Data shows coronavirus infection rate might be slowing

1st October 2020

The R rate has fallen but prevalence of infection is at a record level

Data from over 80,000 volunteers in England tested between 18 and 26 September as part of the country’s largest study into COVID-19 indicate that the overall rate of infection could be slowing.

Interim findings from Imperial College London and Ipsos MORI show that round 1 in 200 people are infected with the virus but that the R rate has fallen to around 1.1.

The report does show that prevalence of infection increased across all age groups and regions, being highest in the 18 to 24 years age group, with 1 in 100 people infected, and a seven-fold increase in cases in those aged over 65.

The North West had the highest levels of infection and the number of infections in London increased five-fold.

“While our latest findings show some early evidence that the growth of new cases may have slowed, suggesting efforts to control the infection are working, the prevalence of infection is the highest that we have recorded to date,” said Professor Paul Elliott, director of the programme at Imperial from the School of Public Health.

“This reinforces the need for protective measures to limit the spread of the disease and the public’s adherence to these, which will be vital to minimise further significant illness and loss of life from COVID-19.”

The interim findings are from a study commissioned by the Department for Health and Social Care to examine levels of infection in the general population in England by testing over 150,000 participants each month over a two-week period.

The final report, based on data of all 150,000 volunteers to be tested between 18 September and 5 October, will be published next week.

 

AZ resumes trial of COVID-19 vaccine

14th September 2020

The move follows a green light by the UK's MHRA

AstraZeneca has confirmed that clinical trials assessing its Oxford University partnered coronavirus vaccine AZD1222 have resumed in the UK, following a green light by the Medicines Health Regulatory Authority (MHRA).

On September 6 the standard review process triggered a voluntary pause to vaccination across all global trials to allow review of safety data by independent committees, and international regulators, after one trial volunteer experienced an unexplained illness.

The UK committee has now concluded its investigations and recommended to the MHRA that trials in the UK are safe to resume.

The drug giant said that it could not disclose further medical information but that all trial investigators and participants will be updated with the relevant information.

AZD1222 was co-invented by the University of Oxford and its spin-out company, Vaccitech.

It uses a replication-deficient chimpanzee viral vector based on a weakened version of a common cold virus (adenovirus) that causes infections in chimpanzees and contains the genetic material of the SARS-CoV-2 virus spike protein.

After vaccination, the surface spike protein is produced, priming the immune system to attack the SARS-CoV-2 virus if it later infects the body.

Interim results from the ongoing Phase I/II COV001 trial published in The Lancet in July showed that AZD1222 was tolerated and generated robust immune responses against the SARS-CoV-2 virus in all evaluated participants.

 

Corticosteroids boost survival rates for COVID-19 patients

4th September 2020

Four papers have been published reinforcing evidence that steroids can significantly improve the outcomes for those critically ill with the virus

Four newly-published papers on the use of corticosteroids to treat COVID-19 back prior evidence that outcomes for patients severely affected by the virus can be significantly improved, with one suggesting the risk of death can be cut by up to 20%.

The papers – all published in the Journal of the American Medical Association (JAMA) – include findings of the REMAP-CAP study led in the UK by Professor Anthony Gordon from Imperial College London, which found that patients in intensive care treated with a regular fixed dose of the steroid hydrocortisone for seven days had a better chance of recovery.

A separate study led by researchers at the University of Bristol and the NIHR’s Bristol Biomedical Research Centre provides an evidence summary of global steroid use across seven randomly controlled trials (RCTs) in 12 different countries.

It included data drawn from REMAP-CAP and the NIHR-funded RECOVERY trial – which has already shown that the steroid dexamethasone can be successfully used to treat moderate to severe COVID-19 – and concluded that corticosteroids can slash the risk of death in the most ill patients by up to 20%.

“These findings offer further evidence that corticosteroids can be an important part of COVID-19 treatment for severe patients,” Professor Jonathan Van-Tam, deputy chief medical officer.

“At the beginning of the year at times it felt almost hopeless, knowing that we had no specific treatments. It was a very worrying time. Yet less than six months later, we've found clear, reliable evidence in high quality clinical trials of how we can tackle this devastating disease,” added Professor Gordon, chair in Anaesthesia and Critical Care at Imperial and a consultant in Intensive Care Medicine at Imperial College Healthcare NHS Trust.

“Steroids are not a cure, but they help improve outcomes. Having a choice of different types of steroids, all of which seem to improve patient recovery, is great as it helps ease the problem of drug supply issues.”

“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,” said NHS chief executive Simon Stevens. “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.”

 

Sanofi, GSK launch early trial for COVID-19 vaccine

3rd September 2020

Over 400 participants are being enrolled in the Phase I/II study after promising preclinical safety and immunogenicity data

Sanofi and GSK have begun a Phase I/II clinical trial testing their adjuvanted COVID-19 vaccine in healthy adults.

The vaccine candidate, developed in partnership by the firms, is based on the recombinant protein-based technology used in Sanofi’s seasonal influenza vaccines and GSK’s pandemic adjuvant technology.

The randomised, double blind and placebo-controlled trial is designed to evaluate the safety, reactogenicity (tolerability) and immunogenicity (immune response) of the experimental COVID-19 vaccine candidate.

First results are expected early December and, if positive, will pave the way for initiation of a Phase III trial in the same month. If successful, the companies intend to request regulatory approval in the first half of 2021.

Preclinical data – due to be published later this year –  show an acceptable reactogenicity profile following two injections of the adjuvanted recombinant vaccine, and high levels of neutralising antibodies comparable to levels in humans who recovered from COVID-19 infection.

Sanofi and GSK are currently scaling up manufacturing of the antigen and adjuvant with the target of producing up to one billion doses in 2021.

“The initiation of our clinical study is an important step and brings us closer to a potential vaccine which could help defeat COVID-19,” said Thomas Triomphe, executive vice president and Global head of Sanofi Pasteur. “Our dedicated teams and partner continue to work around the clock as we aim to deliver the first results in early December.”

Roger Connor, President of GSK Vaccines, added: “Moving this vaccine candidate into clinical development is an important moment in the progress towards addressing the global pandemic we are all facing. This builds on the confidence shown by governments already in the potential of this protein-based adjuvanted vaccine candidate, which utilises established technology from both companies, and can be produced at scale by two of the leading vaccine manufacturers globally.”

Development of the vaccine is being supported through funding and a collaboration with the Biomedical Advanced Research and Development Authority, part of the office of the Assistant Secretary for Preparedness and Response at the US Department of Health and Human Services.

 

Kevzara fails in PhIII COVID-19 trial

1st September 2020

Sanofi and Regeneron do not anticipate carrying out further research on Kevzara in COVID-19

Sanofi and Regeneron's rheumatoid arthritis drug Kevzara (sarilumab) has failed to hit targets in a late-stage trial involving patients hospitalised with COVID-19, signalling the end of its development in this area.

The global Phase III trial assessing intravenously administered Kevzara at a dose of 200mg or 400mg in severely or critically ill patients hospitalised with COVID-19 did not meet its primary endpoint and key secondary endpoint when Kevzara was compared to placebo added to usual hospital care.

The findings follow the failure of a separate Phase III trial of Kevzara 400mg in COVID-19 patients requiring mechanical ventilation, which also did not meet primary and key secondary endpoints when the drug was added to best supportive care.

“Although this trial did not yield the results we hoped for, we are proud of the work that was achieved by the team to further our understanding of the potential use of Kevzara for the treatment of COVID-19,” said John Reed, global head of Research and Development, Sanofi.

“In times like these, commitment to properly designed, controlled clinical trials, provides the information and understanding the scientific community needs for fact-based decision making.”

The firm said that while not statistically significant, “numerical trends were observed toward a decrease in duration of hospital stay as well as an acceleration in time to improve clinical outcomes”.

Also, a trend was observed towards reduced mortality in the critical patient group which was not seen in the severe patient group, and the time to discharge was shortened by two-three days in patients treated with Kevzara within the first two weeks of treatment.

However, given the disappointing findings Sanofi and Regeneron did say they do not anticipate conducting further clinical studies for Kevzara in COVID-19, and that more detailed results would be submitted to a peer-reviewed publication later this year.

 

GSK, Vir Bio start study of COVID-19 antibody therapy

1st September 2020

The Phase II/III COMET-ICE study will assess safety and efficacy of antibody treatment in preventing hospitalisation due to COVID-19

The first patient has been dosed in a new Phase II/III study assessing the safety and efficacy of an antibody treatment for COVID-19 being developed by GlaxoSmithKline and Vir Biotechnology.

VIR-7831 (also known as GSK4182136), is a fully human anti-SARS-CoV-2 (Severe Acute Respiratory Syndrome coronavirus-2) monoclonal antibody, designed for early treatment of COVID-19 in patients at high risk of hospitalisation.

The COMET-ICE study, which will enrol around 1,300 patients worldwide who have early symptomatic infection, will assess whether VIR-7831, as a single-dose monoclonal antibody, can prevent hospitalisation due to COVID-19.

Initial read-outs may be available before the end of this year, with complete results expected in the first quarter of 2021, and potentially early access to the antibody treatment as soon as the first half of 2021, the firms noted.

“Treating those with early COVID-19 disease so that it doesn’t become worse is critical both for the patients and for society. Hospital systems are overwhelmed worldwide, with new infections continuing to strain already limited resources,” said George Scangos, Vir's chief executive.

“This study is designed to demonstrate whether VIR-7831 can significantly reduce the need for hospitalisation in high-risk individuals, such as the elderly or those with pre-existing conditions such as lung or heart disease.”

“Monoclonal antibodies directed against the SARS-CoV-2 virus could provide an effective and immediate immune response to COVID-19, bypassing the need for our body to produce its own antibodies, which is particularly important in the absence of an effective vaccine,” noted Dr Hal Barron, chief scientific officer and president R&D, GSK.

“This study will assess the ability of VIR-7831 to prevent high-risk individuals from progressing to severe disease, and in future studies we will also test the antibody’s ability to prevent infection in high-risk patients and to reduce disease severity in patients who are already hospitalised.”

GSK bought a $250-million stake in Vir earlier this year as the companies revealed a collaboration  to research and develop solutions for coronaviruses, including COVID-19.

 

NIHR, UKRI stream £8.4m into coronavirus studies

28th August 2020

The studies aim to increase understanding on immune responses to SARS-CoV-2

NIHR and UK Research and Innovation (UKRI) are streaming £8.4 million into three new UK-wide research studies aiming to understand immune responses to the novel coronavirus.

The researchers hope to develop better tests to define immunity, study the body’s immune response to SARS-CoV-2, and shed light on why some people suffer from severe life-threatening COVID-19 while others have mild or asymptomatic infections but can still transmit the virus.

Crucially, these studies are designed to determine when and how immunity persists or whether people can become re-infected.

The UK Coronavirus Immunology Consortium will receive £6.5 million to bring together leading immunologists from 17 UK universities that will investigate a series of questions, including: how long does immunity from COVID-19 last?; why are some people’s immune systems better able to fight off the virus; and how does the virus ‘hide’ from the immune system and how can this be addressed?

A better understanding of immune responses could provide targets for new therapies to treat COVID-19 and inform the efforts to develop a vaccine, the organisations noted.

“Understanding the complexities of the immune response to SARS-CoV-2 is key to successfully developing new diagnostics, treatments and vaccines against COVID-1,” said Professor Paul Moss, University of Birmingham, who leads the consortium.

“The UK Coronavirus Immunology Consortium will see the UK immunology community come together in an unprecedented way to answer questions that are crucial in helping us control this pandemic, such as how effective immunity is developed and why individuals respond differently to the disease.”

The Humoral Immune Correlates of COVID-19 (HICC) consortium is being given £1.5 million to explore the humoral immune response, focusing on NHS workers and hospitalised patients.

This study will look at the role of antibodies in immunity to SARS-CoV-2 and characterise the antibody response in people who have mild or asymptomatic infection versus those who develop moderate or severe COVID-19 disease.

The researchers are striving to increase understanding on the differences between protective antibody responses versus harmful ones, which will help determine why people with stronger responses may have had more life-threatening disease, and develop better tests to diagnose protective immunity.

“Understanding the role of antibody responses to SARS-CoV-2 and the critical role that overshooting immune system activation plays in driving the disease processes associated with COVID-19 is critical to optimising management of severe acute COVID-19 disease and developing the most effective vaccination strategies,” said Dr Helen Baxendale, Royal Papworth Hospital NHS Trust, one of the consortium's leaders.

“In critical care, we know most patients have high levels of antibodies to SARS-CoV-2; however, we don’t know whether these antibodies are helpful. Pilot data has shown that many of our NHS staff have been exposed to SARS-CoV-2, but we don’t know whether this means they are protected from further infection either in the short or the long term, or may be at risk of disease in the future. Understanding the types of antibody responses will allow us to determine beneficial antibodies from bad ones.”

The third study – Inflammation in COVID-19: Exploration of Critical Aspects of Pathogenesis, or ICECAP – will receive funding of £394,000 to focus on the key features of fatal COVID-19 and the impact the virus has upon the lungs and other vital organs.

Using hospital post-mortem examinations of patients who have died from COVID-19, the study will assess the effect of the disease on the whole body, analysing tissue samples collected during these examinations to collect crucial information on the presence of COVID-19 in multiple organs across the body.

The study is led by Dr Christopher Lucas at the University of Edinburgh, who said: “We have learned so much from COVID-19 patients during the past six months. However, there is only so much that we can learn from clinical examinations and blood tests.

“By having a deeper look at those who have died from COVID-19 through post-mortem examination, we will increase our understanding of what is happening to the body in the most severe cases of this disease. Critically, this will allow us to rapidly answer key clinical questions and help inform the care of patients and the development of new treatments.”

 

Scancell receives funding for COVID-19 vaccine development

27th August 2020

It is hoped that the vaccine will generate protection not only against SARS-CoV-2, but also against new strains of coronavirus that may arise in the future

Scancell Holdings has secured funding of around £2 million from Innovate UK to initiate a Phase I clinical trial of an experimental SARS-CoV-2 vaccine.

Scancell’s DNA vaccines target dendritic cells to stimulate high avidity T cells that identify and destroy diseased cells.

This technology has been successfully applied with Scancell’s lead ImmunoBody cancer vaccine, SCIB1, which was safely administered to patients with malignant melanoma in a Phase I/II clinical trial with “outstanding five-year survival,” according to the firm.

Scancell aims to use this technology platform to produce a simple, safe, cost-effective and scalable vaccine that induces both durable T cell responses and virus neutralising antibodies (VNAbs) to provide long-lasting immunity against COVID-19.

The vaccine will target the SARS-CoV-2 nucleocapsid (N) protein in addition to the key receptor-binding domain of the spike (S) protein, in order to generate both T cell responses and VNAbs against the SARS-CoV-2 virus.

As the N protein is highly conserved amongst coronaviruses, this new vaccine has the potential to generate protection not only against SARS-CoV-2, but also against new strains of coronavirus that may arise in the future.

“T cells, and particularly high avidity T cells, are becoming increasingly recognised as an important factor in vaccine design for inducing long-term immunity against SARS CoV-2,” noted Professor Lindy Durrant, Scancell's chief scientific officer.

“Patients who had recovered from the original 2003 SARS infection have measurable T cell responses many years following recovery. We have been able to translate our ability to stimulate high avidity T cells to treat melanoma into a vaccine that can potentially provide an effective and durable immune response to COVID-19.”

“Although other vaccines are already in clinical trials, we believe that our approach could result in a second generation vaccine with more potent and long-lasting responses, particularly in the elderly, leading to better protection against COVID-19,” added Dr Cliff Holloway, the firm's chief executive.

 

No increased risk from COVID-19 for healthy pregnant women

26th August 2020

Pregnant women were no more likely to suffer severe symptoms of COVID-19 or be ill for longer than those who weren’t pregnant, if otherwise healthy

Healthy pregnant women are not at higher risk of falling seriously ill from COVID-19 than healthy women not pregnant, suggests a study from King's College London.

The observational study focused on two groups of pregnant women – the first taken from 4 million UK and 50,000 Swedish users of the COVID Symptom Study app, and the second from around 1.9 million women aged 18-44 who responded to the US-based Facebook COVID-19 Symptom Survey.

Researchers analysed self-reported health data from around 14,000 pregnant women using the app, of whom 629 were likely to have COVID-19 based on their symptoms and 21 were hospitalised. They compared this with data from 387,000 non-pregnant female app users, where just over 25,000 were suspected to have the disease and nearly 600 ended up in hospital.

For the second group, they looked at around 1.3 million survey responses from women, including nearly 42,000 from those who said they were pregnant. Just 2.9% of the pregnant respondents were suspected to have COVID-19 versus 4% of the non-pregnant women.

The most common symptoms experienced by pregnant women were found to be similar to non-pregnant people, including persistent cough, headache, loss of taste or smell (anosmia), chest pain, sore throat and fatigue.

However, there was an increased incidence of gastrointestinal symptoms such as nausea and vomiting in the subset of pregnant women who became most severely ill with COVID-19, which the researchers note could be confused with similar symptoms due to pregnancy itself.

The researchers found that although pregnant women reported being tested more frequently for coronavirus, they were no more likely to suffer severe symptoms of COVID-19 or be ill for longer than those who weren’t pregnant, if otherwise healthy.

Pregnant women with underlying health conditions were more likely to end up in hospital with COVID-19, but this was found to be at a similar rate to what has been observed for comparable groups in the general population, the researchers note.

“Although our findings should be reassuring for healthy women who are pregnant at this time, it highlights the importance of protecting those with underlying health conditions and keeping a close eye on them during their pregnancy, particularly if they start showing symptoms of COVID-19,” said MRC Research Fellow, Dr Erika Molteni from the School of Biomedical Engineering & Imaging Sciences.

“It’s vital that we all keep taking steps to protect the health of everyone in our communities by sticking to social distancing guidelines, wearing face coverings in public and following good hand hygiene practices.”

 

Clinical research cut 87% at peak of pandemic

25th August 2020

The model suggests that just 13% of full-time academics would have been available to carry out research during the height of the pandemic

At the peak of the COVID-19 pandemic, clinical research capacity may have been slashed by up to 87% in England, according to a new study led by UCL academics.

The research, published on PLOS One, estimated that at a population infection rate of 10% – at the peak in April, for over a month – less than 400 of the 3,200 (13%) full-time clinical academics in England would be available to carry out any research.

“The urgent need for clinicians to be on the frontline at the height of the COVID-19 pandemic is likely to have resulted in major shortages of clinical academics (doctors with combined roles in medical care and research),” said lead author, Dr Amitava Banerjee (UCL Institute of Health Informatics).

“A major part of the global response to COVID-19 continues to be the research response, whether clinical trials of new treatments and vaccines, or epidemiologic studies of at-risk populations in intensive care units. Clinical academics are vital to this research effort and “translating” discoveries to patient care.”

The team of researchers from UCL, University College London Hospitals, Health Data Research UK (HDR UK), Ospedale Papa Giovanni XXIII Hospital (Bergamo, Italy) and Minneapolis Heart Institute (USA), based their model on the infection rate in England’s population, strain on the healthcare system and availability of clinical academic staff.

At a 10% infection rate, the model showed that it would have taken until early July to recover to 80% of usual clinical academic capacity, and potentially until October or November if the population infection rate was allowed to rise to 40%, the researchers said.

“Even though it seems that there is a lot of COVID-19 research happening in the UK and worldwide, academic capacity has been affected and needs to be planned and preserved, not just for COVID-19 studies, but also work relating to non-COVID-19 diseases,” said Dr Banerjee. “This is highly relevant to ongoing efforts to keep infection rates down and potential second waves of infection.”

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