March 2021 • PharmaTimes Magazine • 12-13

// COVID-19 //


£18.5m for long COVID research

The UK government is streaming funds of £18.5 million into four research projects striving to improve understanding of the longer-term effects of COVID-19, known as long COVID.

Around one in ten people with COVID-19 will continue to experience symptoms and impaired quality of life after 12 weeks. A systemic review has identified 55 individual long-term effects of long COVID, although common symptoms include breathlessness, headaches, cough, fatigue and cognitive impairment.

The studies to receive government backing, chosen by an independent panel of experts and long COVID patients, seek to identify the causes of long COVID and effective therapies for the treatment of people who experience chronic symptoms following infection with the SARS-CoV-2 virus.

The REACT long COVID (REACT-LC) study will look at people in the community who took part in the REACT study to find common factors to determine why some develop long COVID and others do not.

The Therapies for long COVID in non-hospitalised individuals: from symptoms, patient-reported outcomes and immunology to targeted therapies, or TLC study, aims to identify the most beneficial treatments for people with particular symptoms of long COVID.

Another study, Characterisation, determinants, mechanisms and consequences of the long-term effects of COVID-19: providing the evidence base for healthcare services, will use data from over 60,000 people to help define long COVID and improve diagnosis, while the Non-hospitalised children and young people with long COVID, or CLoCk study, aims to help improve understanding of long COVID among children, as well as how it can be diagnosed and treated.

“Good research is absolutely pivotal in understanding, diagnosing and then treating any illness, to ease symptoms and ultimately improve lives,” said Chris Whitty, chief medical officer of England and head of the National Institute for Health Research (NIHR). “This research, jointly funded through the NIHR and UKRI, will increase our knowledge of how and why the virus causes some people to suffer long-term effects following a COVID-19 infection – and will be an important tool in developing more effective treatments for patients.”


LifeArc provides £5m for COVID-19 genomics study

Medical research charity LifeArc is providing funds of £5 million to support the GenOMICC COVID-19 study, which aims to understand the role of genetic risk factors in patient responses to COVID-19.

The study, which has already received £4.6 million from the UK Department of Health and Social Care (DHSC), is being led by the GenOMICC consortium in partnership with Genomics England to evaluate why some people are affected more severely by COVID-19 than others.

“It is hoped that this programme will provide rapid insights that can inform accurate diagnostics, and potential targets for drug development,” said Melanie Lee, chief executive officer of LifeArc. “We hope this work will also help inform the 15 clinical studies that we have funded into investigating existing drugs for efficacy in COVID patients, as part of the £27 million LifeArc has now allocated to research projects to tackle the COVID-19 pandemic.”

“Genomics is already giving us critical insights, as the partnership’s recent Nature paper and many others have shown. LifeArc’s support will allow us to accelerate and scale these insights and continue to feed them into clinical trials, clinical practice and fundamental research,” noted Chris Wigley, chief executive officer at Genomics England.


Rolling review for CureVac’s vaccine

German biopharma CureVac has initiated a rolling review with the European Medicines Agency (EMA) for its mRNA-based COVID-19 vaccine, CVnCoV.

The rolling review is a ‘time-optimised’ pathway which aims to provide and review all data needed for a potential market authorisation during a public health emergency.
CureVac’s CVnCoV is currently being investigated in a randomised, placebo-controlled Phase IIb/III clinical trial – HERALD – in healthy adults at sites in Europe and Latin America.

In Phase I, the vaccine was found to be generally well-tolerated across all tested doses and induced strong antibody responses as well as the first indication of T cell activation, while the quality of the immune response seen in CVnCoV-vaccinated participants was comparable to recovered COVID-19 patients.

“We are confident in the potential of our mRNA technology to contribute to the fight against the global public health emergency that is COVID-19,” said Dr Lidia Oostvogels, vice president area head infectious diseases at CureVac. “Working together with the EMA to initiate a rolling regulatory process is a critical step in enabling potential access to our vaccine by the many people who still need protection from this deadly disease,” she added.


NHS to roll out tocilizumab for COVID-19

The UK government has announced that the arthritis medicine tocilizumab will be offered to thousands more NHS patients after the drug was found to reduce the risk of death in people with COVID-19.

In the RECOVERY trial, tocilizumab significantly reduced deaths, with 29% of the patients in the tocilizumab-treated group having died within 28 days compared to 33% in the placebo group – an absolute difference of 4%.

The anti-inflammatory treatment also increased the probability of discharge alive within 28 days from 47% to 54%, with benefits observed in all patients subgroups – including patients requiring oxygen via a face mask and those requiring mechanical ventilators in an intensive care unit.

When administered with the corticosteroid dexamethasone, tocilizumab reduced the relative risk of death by 14% and reduced the time spent in hospital by five days when used for patients on oxygen.

Tocilizumab is marketed as Actemra/RoActemra by Swiss pharma company Roche, and is approved in a number of inflammatory conditions such as rheumatoid arthritis, paediatric juvenile idiopathic arthritis (pJIA) and more.


Study to investigate vaccine mixing

A UK-based clinical study is investigating whether alternating COVID-19 vaccines can safely be used for two-dose vaccination regimens.

The Com-Cov study will be the first in the world to evaluate the effects of using different vaccines for the first and second dose within a two-dose vaccination regimen, such as AstraZeneca/Oxford University’s vaccine for the first dose and Pfizer/BioNTech’s for the second.

The study will be run by the National Immunisation Schedule Evaluation Consortium (NISEC) across eight National Institute for Health Research (NIHR) supported sites for 13 months, monitoring the impact of different dosing regimens on immune responses.

Initial findings are expected to be published in the summer.