According to current British government data, there have been nearly 300,000 confirmed cases of Covid-19 and more than 45,000 people have died.
The scale of this tragedy is therefore enormous. And while a vaccine such as that tested by the University of Oxford (hopefully) will prevent or reduce the impact of the virus, it will not eliminate the need for therapies to treat people who fall ill as a result of the infection. Even when we have an effective vaccine, it will take many months and even years before we increase production and develop logistics to deliver it worldwide. And dealing with only a subsection of the world’s population is neither ethics nor good science.
Sars-CoV-2 infection causes a number of health problems, the most common of which is lung inflammation, resulting in difficulty in transferring oxygen from the air pockets into the lung (alveoli) to the blood, sometimes referred to as respiratory failure.
On Monday, Synairgen (a spin-out company from the University of Southampton) announced that a small clinical study of inhaled interferon beta-1a showed that this treatment can be effective in hospital patients with Covid-19. But there have been many similar announcements about disease therapies that have subsequently proven to be disappointing: is it different?
Interferon beta-1a is a substance that the body naturally produces as part of its immune response to viral infections. Laboratory data suggesting that interferon beta may help protect cells, such as those in the lungs, from other coronavirus infections (such as Mers and Sars) has led to concern if it could be an effective therapy for Sars infection. -CoV-2. Synairgen had previously developed an inhaled form of interferon beta-1a as a therapy for patients with asthma and chronic obstructive airway disease (COPD), so it was well positioned to undertake a clinical trial in patients with Covid-19.
The results announced Monday came from a study that recruited around 100 patients from nine hospitals in the UK and aimed to determine whether the therapy was well tolerated and whether it could prevent or accelerate recovery from respiratory infection caused by Sars-CoV-2. All patients enrolled in the study tested positive for Sars-CoV-2 and were in the hospital. The press release states that the chances of patients deteriorating clinically to the extent that they required mechanical ventilation or died were reduced by 79%. Synairgen also states that patients who received therapy were more likely to recover in the 14-day treatment period than those who did not.
Did we really find the therapy we were looking for? Could be. Maybe not. This clinical trial is small in size (~ 50 patients received therapy and ~ 50 patients received placebo). It was designed to see if the therapy was tolerated by patients and if it could be effective. So far, we only have one press release suggesting that these things may have happened – what we need to see is real research data. The claim of a 79% reduction in the risk of needing mechanical ventilation or dying seems bright. I am an ICU specialist who knows all too well how great the need for therapy like this is; according to the latest data from the Intensive Care National Audit & Research Center, over 7,000 people hospitalized in the intensive care units of the United Kingdom have needed mechanical ventilation and over 4,000 people have died. However, we must remember that only about 50 people received this therapy and while the press release tells us that three people (6%) who received the placebo died, it does not tell us the number of people who required mechanical ventilation. So we can’t say how significant the effect of this drug is, but the reality is likely to be less surprising than the impression given by that “79%”.
If the entire research dataset, when published, looks good, interferon beta-1a therapy should subsequently be tested in large randomized controlled trials. I’m sure there will be people who suggest that therapy should be immediately brought to routine clinical practice without further testing, but we must be cautious. There are many examples of therapies that looked promising in early clinical trials which, when tested in larger studies, showed no benefit or harm.
While I am playing a note of caution, there is also reason to celebrate. This research trial was yet another result obtained through the clinical trial infrastructure developed by the National Institute for Health Research that was so successful during the pandemic. The NIHR has enabled the United Kingdom to make world-leading progress in treatments for Covid-19. For example, the recovery study has already shown that dexamethasone works for hospital patients who need oxygen or mechanical ventilation and that hydroxychloroquine and lopinavir / ritonavir do not. In addition, NIHR is supporting a series of early and late clinical trials that test other therapies, all together to provide multiple vaccine studies.
Covid-19 has led the NIHR to demonstrate that it is capable of delivering health research on a scale and speed unmatched anywhere else in the world, and that’s definitely something to be happy about.
• Dr. Charlotte Summers is a professor of intensive medicine at the University of Cambridge