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Gilead Science have announced the beginning of phase 3 randomised studies of remdesivir in the UK, in patients with moderate or severe COVID-19.
Prof Sir Munir Pirmohamed, President of the British Pharmacological Society, said:
“It is great to see these trials will go ahead in the UK. I am delighted that MHRA, the Health Research Authority and other regulators have been able to turn this around and approve the trials in such a short period of time.
“Remdesivir is one of a number of promising agents that have been proposed for the treatment of COVID-19. However, it is an investigational agent. As Gilead’s press release highlights, whilst it has demonstrated activity in vitro and in animal models, clinical trials will be crucial in demonstrating whether it is safe and effective for use in patients with COVID-19.
“We know our healthcare system is under intense pressure at the moment, but nevertheless, it is crucial that our hospitals and the associated healthcare staff, are allowed to recruit patients to such trials in a timely manner, reducing bureaucracy whilst ensuring Good Clinical Practice standards are upheld.”
Prof Stephen Evans, Professor of Pharmacoepidemiology, London School of Hygiene & Tropical Medicine, said:
“It is really good that possible innovative treatments for patients with moderate or severe Covid-19 are having properly randomised trials. It is vital that such trails are conducted so that evidence on efficacy and safety is obtained in a valid way.
“This drug, remdesivir, is not yet a licensed medicine in any indication, so experience is limited in its widespread use. It is vital that its safety is very carefully monitored in the trials.
“There is limited experience with the drug in treating other viruses, notably Ebola, but its efficacy was not dramatic, and caution requires that it should not be encouraged to be used widely before convincing evidence is found on its safety as well as efficacy.”
Prof Adam Finn, Professor of Paediatrics, University of Bristol, said:
“Paediatricians are pleased that Gilead have included children from the age of 12 years in these two studies.
“Although children are less badly affected by this infection than adults, we are already beginning to see severe cases and it will be important to gather information about this and other potential therapies in this age group.
“We believe that it is very important that unproven therapies should not be used except in the context of properly designed controlled studies like this for the benefit of our patients now and in the future and to ensure our efforts and resources will be directed towards treatments that are effective and safe.”
Dr Andrew Freedman, Reader in Infectious Diseases, Cardiff University, said:
“There is, as yet, no proven effective drug treatment for COVID-19, although a number of different agents have been used and are continuing to undergo evaluation in clinical trials. Remdesivir is one such drug; it is known to have activity against a number of different viruses, including the coronaviruses that cause SARS and MERS, although it is not currently licensed for use in any infection. The announcement today that the manufacturer, Gilead, has initiated multi-centre international trials of this drug, including at several UK centres, is very welcome news. There is an urgent need to identify effective treatment for COVID-19 that could reduce the morbidity and mortality, using rigorous clinical trials.”
Prof Graham Cooke, NIHR Research Professor, Imperial College London, said:
“Remdesivir is one of the most promising treatments for COVID-19. Although it looks promising in the test tube, we need clinical studies to test whether it meaningfully improves the outcomes of illness for patients. Several NHS sites will be taking part in these two international trials, giving patients early access to treatment, alongside other studies comparing the performance of different potential treatments. The next few weeks will see a huge amount of trial data emerging which will hopefully help to improve patient outcomes during this current peak in the pandemic.”
Dr Stephen Griffin, Associate Professor, Leeds Institute of Medical Research, University of Leeds, and Chair, Virus Division, Microbiology Society, said:
“The news that Gilead is supporting phase three UK COVID19 trials for remdesivir is most welcome. This broad-spectrum antiviral agent is well accepted to hold promise for the treatment of COVID19, based upon efficacy in SARS-CoV2 and related coronavirus model systems. Critically, the proposed clinical studies will allow the true efficacy of this agent to be determined in the human scenario, plus the numbers of patients involved should highlight any potential safety concerns in COVID patients that may not be evident from its previous use on a compassionate basis. However, remdesivir trials did take place during the Ebola outbreak in western Africa, and others are ongoing for the treatment of patients with ongoing Ebola infections.
“Given that a SARS-CoV2 vaccine may require several months to develop and scale up, an effective antiviral therapy has tremendous potential to lessen the severity of COVID19 in the short to medium term. Thus, despite the need for intravenous administration, use of this agent in a hospital setting could have a profound impact upon the ability of healthcare systems to cope with this extraordinary pandemic.”
All our previous output on this subject can be seen at this weblink:
www.sciencemediacentre.org/tag/covid-19/
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