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PDA Pandemic Series Update – 4 August 2020

With each edition, we will aim to bring to your attention important issues either those that we are working on or general background information that helps you with your practice.

Tue 4th August 2020 The PDA

In previous editions, we have looked at the vaccine development programme in the battle against COVID-19. However, there has been a global effort to identify suitable treatments to reduce the impact of COVID-19 on patients, especially those that need to be hospitalised. There is no certainty on the efficacy of a potential vaccine so it is vital that if patients become severely ill with COVID-19 then there are potential treatments to reduce the severity of the infection and especially the need for (and duration of) mechanical ventilation.

During the initial stages of the pandemic, many desperately ill patients were treated with medications “off-license” or those made available on a “compassionate use basis” (i.e. those that are unlicensed and in development stage) especially with many other standard treatments having little impact for these severely ill patients.

For example, Remdesivir which was an unlicensed product globally (for any treatment) but when used in open-label trials it has yielded such good initial results that it has now become the front runner in all the potential treatments for COVID-19. Further trials are ongoing.

In Italy, patients with severe COVID-19 pneumonia who were admitted to tertiary care centres were treated with a range of antivirals, azithromycin etc and a non-randomised subset were treated with tocilizumab (a monoclonal antibody used to treat rheumatoid arthritis).

A retrospective observational study of these non-randomised patients treated with tocilizumab found it to have reduced mortality and the need for mechanical ventilation. Controlled trials are now planned to determine efficacy and safety.

Thus, the initial observational information garnered has not been wasted as these observational studies have provided useful information for later clinical trials following usual protocols.

There are 3 broad strands of research focusing on treatment with anti-inflammatories, treatment with antibodies and treatment with antivirals. Some papers merge the anti-inflammatories and antibody treatments as one strand which they term “immune modulators” and the second strand as antivirals.

In excess of 4,000 trials have been registered in trails databases globally, even though many have not started recruiting patients. Given the scale of research globally, there are various databases that list trials, the stage they are at and the number of patients within the trial.

To bring some order to this global research and to expedite trials, WHO launched what is termed the “Solidarity Trial” which compares a variety of options against standard care, to assess their relative effectiveness against COVID-19. By making it simple for institutions worldwide to participate, WHO hopes to enrol large numbers of patients (in excess of 5,500 as at 1/7/2020) across over 100 countries to rapidly discover treatments that are efficacious. These phase III / IV trials will test a variety of treatments against standard care.

Similarly, the UK based “RECOVERY trial”, which has leveraged the capacity of 175 NHS hospitals with its simple design has led to rapid identification of promising treatments (such as dexamethasone). In excess of 11,000 (as at 1/7/2020) patients have been enrolled in this trial.

The RECOVERY trial also found that the initial early excitement surrounding the potential impact of hydroxychloroquine has, for hospitalised patients, proved to be of little benefit. The UK RECOVERY trial published its findings on Hydroxychloroquine in June 2020.

The COVID-19 pandemic has led to an unprecedented global effort to find effective treatments and more detailed information about the most promising treatments can be found in the following links.

  • You can read more about potential antiviral treatments for COVID-19 here.
  • You can read more about potential anti-inflammatory treatments used for COVID-19 here.
  • You can read more about antibody treatments used for COVID-19 here.
  • You can read more about the WHO Solidarity Trial here.
  • You can read more about the RECOVERY Trial here.
  • You can read more about the Hydroxychloroquine Trial here.

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