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The world’s largest clinical trial investigating treatments for COVID-19 has now launched in South Africa, with the first patient recruited today. This is the fifth country to take part in RECOVERY, joining Nepal, Indonesia, Vietnam, and the United Kingdom.
Since March 2020, the RECOVERY Trial has discovered three effective treatments for COVID-19: the inexpensive steroid dexamethasone; the arthritis drug tocilizumab; and a monoclonal antibody treatment, now known as Ronapreve. As the pandemic continues to affect both high and lower income countries, treatments are needed that are suitable for a wide range of patients and healthcare systems.
Sir Peter Horby, Professor of Emerging Infectious Diseases in the Nuffield Department of Medicine, University of Oxford, and Joint Chief Investigator of RECOVERY, said: ‘I am absolutely delighted that South Africa has joined RECOVERY. South African scientists, medical professionals and patients have already made an enormous contribution in the fight against COVID. By working together on RECOVERY we hope to further accelerate progress towards finding globally relevant solutions to this terrible disease.’
Emmanuelle Denis, who liaises between the Oxford-based RECOVERY team and investigators outside the UK, said: ‘We are very excited to be expanding RECOVERY into South Africa in collaboration with Wits Health Consortium and the University of Cape Town. Expanding RECOVERY recruitment to Africa will help to further the continent’s capacity to conduct adaptive streamlined clinical trials and will provide important insights into the effectiveness of study treatments in a different patient population.’
In South Africa, RECOVERY will initially focus on whether using a higher dose of the anti-inflammatory treatment dexamethasone (compared to standard doses of the drug previously shown to save lives in the RECOVERY trial) has an even greater effect. The hospital sites taking part include major academic hospitals in Johannesburg, Cape Town, Bloemfontein and Durban, ensuring that a good mix of COVID-19 patients will have the opportunity to enrol in the trial. All participants will receive the usual care in the participating hospitals.
Dr Jeremy Nel, co-national Principal Investigator (PI) for RECOVERY along with Professor Helen Rees, said: ‘We are proud to be able to contribute to such an important endeavour. Results from RECOVERY have informed national guidelines across the world, and saved a great many lives as a result. If we’re able to contribute in some small way to the success of the platform, then it’ll be an honour.’
Professor Marc Mendelson (site Principal Investigator for Groote Schuur Hospital in Cape Town) added: ‘We are delighted to take part in the RECOVERY Trial, whose platform has been so successful in defining the clinical management of COVID-19. But for RECOVERY to have true global relevance, it is critical to include people living in different geographic regions and socioeconomic circumstances. For instance, countries such as South Africa are focal areas for comorbid infections not commonly encountered in the UK, principally HIV and tuberculosis, both of which affect COVID-19.’
RECOVERY and other randomised trials have demonstrated the benefit of corticosteroids such as dexamethasone for patients with inadequate levels of oxygen (hypoxia), whilst other randomised clinical trials in critically ill COVID-19 patients have used higher doses of dexamethasone and reported clinical benefit. However, the higher doses have not been compared with the lower dose used in RECOVERY, and so there is uncertainty regarding the best dose for hospitalised patients.
Higher doses of corticosteroids are used to control inflammatory processes in other illnesses, including bacterial meningitis, tuberculous meningitis, and community acquired pneumonia; they may be beneficial for COVID-19 patients and could offer an alternative treatment option for clinicians.
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. This has already supported the expansion of the trial into Vietnam, Nepal and Indonesia.
About the Covid-19 Therapeutics Accelerator
The Therapeutics Accelerator is an initiative launched by the Bill & Melinda Gates Foundation, Wellcome, and Mastercard with support from public and philanthropic donors to speed up the response to the COVID-19 pandemic by identifying, assessing, developing, and scaling up treatments. Its partners are committed to equitable access, including making products available and affordable in low-resource settings.