World’s largest clinical trial for COVID-19 treatments expands internationally

The Randomised Evaluation of COVID-19 Therapy (RECOVERY) Trial, the world’s largest clinical trial for COVID-19 treatments, has now expanded internationally with Indonesia and Nepal among the first countries to join. The first patients have been recruited to RECOVERY International.

Peter Horby, Professor of Emerging Infectious Diseases and Global Health in the Nuffield Department of Medicine, University of Oxford, and Joint Chief Investigator for the trial, said, ‘The RECOVERY trial has been an enormous success, enrolling over 36,000 patients and delivering clear results on six treatments already. By building on this success through international partnership we can speed up the assessment of novel treatments, increase the global relevance of the trial results, build capacity, and reduce wasted efforts on small uninformative studies.’

‘It is particularly important to find readily available and affordable treatments for COVID-19 that can be used worldwide. RECOVERY International will help us to identify effective treatments that can be used in less well-resourced settings,’ he added.

The RECOVERY trial was launched rapidly in the UK in March 2020 to investigate whether any existing treatments were effective against COVID-19. It is open to all patients admitted to NHS hospitals with COVID-19, with over 36,000 patients recruited so far. The trial has already delivered results that have changed clinical care, including the findings that the inexpensive steroid, dexamethasone, and the anti-inflammatory treatment, tocilizumab, significantly reduce the risk of death when given to hospitalised patients with severe COVID-19.

In Indonesia and Nepal, the trial will initially focus on the treatments aspirin and colchicine, since these are readily available and affordable but, like RECOVERY in the UK, the trial is adaptive and new drugs will be added over time.

The expansion of RECOVERY internationally has been made possible thanks to the longstanding work of the Oxford University Clinical Research Unit (OUCRU), which has campuses in Kathmandu in Nepal (OUCRU Nepal) and Jakarta in Indonesia (Eijkman-Oxford Clinical Research Unit, EOCRU). OUCRU Nepal exists in partnership with Patan Academy of Health Sciences and Patan Hospital in Kathmandu and the trial is being delivered in collaboration with the Nepal Health Research Council. In Indonesia, the RECOVERY trial is being delivered through the longstanding research partnership between the University of Oxford and Faculty of Medicine University of Indonesia (FKUI), and several hospitals.

Dr Erni Nelwan, who will lead the trial in Indonesia on behalf of FKUI, said, ‘We are really excited that our investigators will have the experience of being part of a high-profile, global trial. In return, we can provide a more diverse patient population, including those more severely affected by the disease.’

‘RECOVERY has already helped Indonesia to plan its resources more effectively. For instance, because of the trial’s results, chloroquine/hydroxychloroquine is no longer recommended in Indonesia to treat COVID-19, with dexamethasone now widely used instead,’ said Professor Raph Hamers, who will co-lead the trial in Indonesia on behalf of Oxford University.

‘The Nepal team is super-excited to be aligned with Oxford University's RECOVERY, the largest COVID-19 drug trial in the world so that these ground-breaking findings also become relevant in the context of low- and middle-income countries,’ added Professor Buddha Basnyat, Director of OUCRU Nepal.

The Co-lead from Nepal, Dr Pradip Gyanwali, member secretary of the Nepal Health Research Council adds that Recovery International has excellent potential for being very useful for Nepal.

‘Launching RECOVERY internationally is a tremendous achievement’ said Emmanuelle Denis, who liaises between the main Oxford-based RECOVERY team and the overseas sites. ‘In the UK, the trial could be rolled out rapidly thanks to the joined-up nature of the NHS. It is much more challenging to replicate such a large trial in countries without this integrated infrastructure, but thanks to our longstanding relationships and the willingness of research partners in Nepal and Indonesia to be involved, we are now able to recruit in these countries.’

Dr Nick Cammack, COVID-19 Therapeutics Lead at Wellcome, said, ‘The opening of an international RECOVERY trial is an important moment in the search for effective treatments against COVID-19 that can be used across the globe. Researching treatments that are affordable and readily accessible in low- and middle-income countries means that the results can be rapidly utilised in these nations.’

‘This new research will also help us to understand how other diseases that are endemic in some countries, such as TB and HIV, can affect COVID-19 and its treatments.’

‘COVID-19 can be a preventable and treatable disease, but only if we invest in research now. A pipeline of new treatments is essential if we are to reduce further deaths and suffering, and to keep pressure off health systems. Investing in research into a wide range of treatments, alongside vaccines and testing, and ensuring all advances are fairly available globally, remains our only exit from the pandemic.’

Funding for RECOVERY International was provided by Wellcome, in collaboration with the UK Foreign, Commonwealth and Development Office (FCDO), on behalf of the COVID-19 Therapeutics Accelerator, initially for a two-year period.