RECOVERY trial, antibodies, and other news

by Last updated Jun 28, 2020 | Published on Jun 23, 2020Biomedical Communications, Drug Development & Clinical Trials, Newsletter0 comments

man reading newspaper

Hi there,

This week I bring you some of the weeks’ news that caught my attention. The first one will only be news for you if you’ve been hiding under a rock or swamped with work—in any case, I have your back 😊

Then, we revisit the antibody (or lack of) subject, try to keep politics away from health in Brexit, and check out the situation with delayed clinical trials.

recovery trial and dexamethasone graphic

DEXAMETHASONE SHOWS PROMISING RESULTS IN RECOVERY TRIAL

The RECOVERY (Randomised Evaluation of COVid-19 thERapY) trial started in March 2020 to test a series of potential treatments for COVID-19, including low-dose dexamethasone (a type of steroid drug). On June 8th, the trial Steering Committee halted recruitment to the dexamethasone arm because they thought that enough patients had been enrolled to assess the benefit of the drug (or lack of it). At that point, 2104 patients had been randomised to receive dexamethasone 6 mg once per day for ten days and compared with 4321 patients randomised to usual care.

The results showed a benefit to those who received dexamethasone, reducing 28-day mortality by one-third in ventilated patients and by one-fifth in patients who required oxygen. There was no benefit among the patients that didn’t require respiratory support. You can check out more details on the RECOVERY trial page.

These results are consistent with what we know about COVID-19 clinical course, in which the patients that develop the more serious disease show an overreactive inflammation process and thus may benefit from an anti-inflammatory such as dexamethasone. I’m curious about what the results from tocilizumab (an IL-6 inhibitor) will be.

are you immune if you have antibodies graphic

ARE YOU IMMUNE IF YOU HAVE ANTIBODIES?

Immunity is a tricky subject. Having antibodies against a specific agent doesn’t necessarily protect you from the disease, and the antibodies you produce may have a short lifespan. I’ve previously wrote about the role of antibodies in COVID-19, and a new study in Nature Medicine shows that immunity to SARS-CoV-2 may fade quickly, at least in people with light to moderate symptoms. The objective of this study was to assess the immune response in 37 individuals, divided in two groups: one asymptomatic and one with mild symptoms. The investigators also described clinical characteristics and virus levels in both groups.

The results showed that roughly 20% of people (in both groups) didn’t develop a detectable IgG response to their SARS-CoV-2 infection. For IgM, the number of people that didn’t develop an immune response was even higher, with up to 40% of infected individuals failing to produce IgM antibodies. The researchers also measured the levels of IgG neutralising antibodies and found that they significantly declined after eight weeks in most patients.

These findings, albeit in a small number of people, raise some concerns about the protective immune response, which have implications in public health and vaccination strategies.

AGAINST THE COLLAPSE OF FREE TRADE IN A POST-BREXIT WORLD

The biopharma industry is trying to persuade the European Union to separate the discussion about post-Brexit regulatory cooperation from broader political regulations. In a joint letter to EU officials, the six trade groups that comprise the European Federation of Pharmaceutical Industries and Associations (EFPIA) ask that the Brexit negotiators prioritise the signing of a mutual recognition agreement. This agreement would cover batch and import testing, good manufacturing practice (GMP) inspections and CE marking, to ensure medicines and medical devices continue to cross the UK-EU border with minimal delays. According to the letter, the COVID-19 “crisis has highlighted the need for closer international health collaboration and dialogue, and the need for governments to work together with industry to ensure a resilient health sector and medicine supply chains.”

While some people may disagree with me, I think cooperation is paramount to improve global health, despite any qualms that may happen in other fields. Science and health should be free of political constraints.

Clinical trials are getting back on track graphic

CLINICAL TRIALS ARE GETTING BACK ON TRACK

The general public may be reading and hearing more about new and ongoing clinical trials, but for those not related to COVID-19, there was a disruption caused by the pandemic in March and April. This was caused by the need to free up clinics and hospitals for other diseases and to reduce risks to patients. Many trials were suspended enrolment, and we don’t have an account of how many new trials were postponed to an indefinite future.

But now, according with a European Pharmaceutical Review report, 200 clinical trials that were delayed by COVID-19 are now continuing or have already finished. So far, the pandemic hasn’t visibly impacted new drug approvals, but we may see some delays in the future when clinical trial data is being evaluated. This is because if large numbers of participants drop out mid-study, there may be too many missing data points, which negatively impact the appraisal of trial results.

And that wraps up the highlights of the week; I hope you found them useful.

Until next week, stay curious.

Diana

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About Diana Ribeiro

About Diana Ribeiro

Diana Ribeiro is a pharmacist and freelance medical writer based in Cascais, Portugal. Before starting her career in medical writing, Diana worked 10+ years in hospital and community pharmacies, where she helped patients and healthcare professionals with drug management and information. Nowadays, she helps pharma, biotech, and meddev companies communicate with their audiences in a clear, accurate, and compelling way. Diana is an active member of the European Medical Writers Association, where she volunteers for the webinar team. You can find more about her on LinkedIn.

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