Supporting RECOVERY for Covid-19

The largest randomized clinical trial for #Covid-19 treatments is making great strides in adaptively testing the treatment options for the UK and the entire world population. We are proud to support the efforts of Oxford University’s Nuffield Department of Population Health, and Nuffield Department of Medicine, with capturing the critical trial data and enabling the flexibility of the adaptive platform method.

The trial is being conducted in over 170 NHS hospital sites across the UK with over 10,000 participants to date. Patients who have been admitted to hospital with COVID-19 are invited to take part. The Chief Medical Officers of England, Wales, Scotland and Northern Ireland, and the NHS Medical Director are actively encouraging enrollment in this study and other major studies in the UK.

The trial is being coordinated by researchers at the University of Oxford, led by Peter Horby, Professor of Emerging Infectious Diseases and Global Health in the Nuffield Department of Medicine and Martin Landray, Professor of Medicine and Epidemiology at the Nuffield Department of Population Health.

Trial Treatments

  • Lopinavir-Ritonavir (commonly used to treat HIV)
  • Low-dose Dexamethasone (a type of steroid, which is used in a range of conditions typically to reduce inflammation).
  • Hydroxychloroquine (related to an anti-malarial drug)
  • Azithromycin (a commonly used antibiotic)
  • Tocilizumab (an anti-inflammatory treatment given by injection)

Trial Design

RECOVERY has an “adaptive” design, with data analyzed on a rolling basis so that any beneficial treatments can be identified as soon as possible and ineffective ones dropped from the trial.

“One of the biggest challenges with trial setup was developing the randomization capabilities, which we built in-house,” said Andrew King, Head of Trials Programming. There are several arms that are included in this study with the need for flexibility to enable quick treatment additions and modifications. There is also a second randomization for tocilizumab and standard of care. The randomization data is easily ingested into the randomization forms within OpenClinica, through the API.

“Building the study and the forms within OpenClinica was very straightforward and quick,” according to David Murray, Senior Trials Programmer. Site staff enter the trial data into the forms, primarily at the 28 day mark. “Another challenge operationally was training the over 4,000 site personnel on the randomization protocols and the EDC system. We found the training for OpenClinica’s EDC to be inconsequential in the process,” said David Murray.

For regular news, updates, and findings, be sure to visit the RECOVERY site. We continue to support many organizations in their efforts to research and ultimately discover effective and safe vaccines and therapies.

Feel free to contact us with any question on how we can help with your clinical studies.

 

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