The RECOVERY Trial – A Randomised Evaluation of COVID-19 Therapy

Funders:

This trial is supported by grants to the University of Oxford from the National Institute for Health Research (NIHR), UK Research and Innovation, and Wellcome, and by core funding provided by the Bill and Melinda Gates Foundation, the Foreign, Commonwealth & Development Office, Health Data Research UK, the Medical Research Council Population Health Research Unit, the NIHR Oxford Biomedical Research Centre, NIHR Clinical Trials Unit Support Funding, and Wellcome Trust.

Principal Investigators

OUCRU: Jeremy Day

EOCRU: Raph Hamers

OUCRU Nepal: Buddha Basnyat

Locations of the study: Nepal, Indonesia, Viet Nam (HCMc and Hanoi)

More information: https://www.recoverytrial.net/

Aims:

This international clinical trial aims to identify treatments that reduce the risk of death in patients hospitalized with suspected or confirmed COVID-19. It is a large multicenter trial recruiting in hospitals in the United Kingdom, Indonesia, Nepal, Viet Nam and Ghana.

 

Study Design:

Well-designed, pragmatic, and easy to implement clinical trials are key to generating the evidence needed to best manage pandemic diseases, which occur essentially in emergency situations. The RECOVERY trial sets this paradigm. It is a large open-label factorial designed platform trial that enables the simultaneous testing of multiple different treatments. As particular treatments are found to be effective or ineffective, they are dropped from the trial and should form part of the standard of care.

The study is designed to have high power to deliver precise estimates of the effect of particular treatments on the risk of death. New treatment interventions are added to the trial as evidence emerges from small scale studies of their possible value. While originally based in the UK, the extension of the RECOVERY trial to international sites, building upon well-established clinical research networks and collaborations, will ensure that the results of the trial have global relevance.

 

Outputs to date:

Having enrolled more than 41,500 patients to date,  RECOVERY has provided precise data demonstrating the efficacy of dexamethasone, tocilizumab, and a cocktail of CoV antibodies (Regeneron) in reducing the risk of death in hospitalized patients, and that hydroxychloroquine, azithromycin, lopinavir-ritonavir, aspirin, colchicine, and convalescent plasma are ineffective. These results have influenced World Health Organisation and national guidelines for the treatment of COVID19. Current treatments undergoing evaluation include high dose corticosteroids and empagliflozin.

 

Publications:

  • RECOVERY Collaborative Group. Aspirin in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial. medRxiv [Internet] 2021; Available from: https://doi.org/10.1101/2021.06.08.21258132
  • RECOVERY Collaborative Group. Azithromycin in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial. The Lancet [Internet] 2021;397(10274):605-612. Available from: https://doi.org/10.1016/S0140-6736(21)00149-5
  • RECOVERY Collaborative Group. Casirivimab and imdevimab in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial. [Internet] 2021; Available from: https://doi.org/10.1101/2021.06.15.21258542
  • RECOVERY Collaborative Group. Colchicine in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial. medRxiv [Internet] 2021; Available from: https://doi.org/10.1101/2021.05.18.21257267
  • RECOVERY Collaborative Group. Convalescent plasma in patients admitted to hospital with COVID-19 (RECOVERY): a randomised controlled, open-label, platform trial. The Lancet [Internet] 2021; 397(10289):2049-2059. Available from: https://doi.org/10.1016/S0140-6736(21)00897-7
  • RECOVERY Collaborative Group. Dexamethasone in Hospitalized Patients with Covid-19. New England Journal of Medicine [Internet] 2021; 384(8):693-704. Available from: https://www.nejm.org/doi/10.1056/NEJMoa2021436
  • RECOVERY Collaborative Group. Effect of Hydroxychloroquine in Hospitalized Patients with Covid-19. New England Journal of Medicine [Internet] 2020; 383(21):2030-2040. Available from: https://www.nejm.org/doi/10.1056/NEJMoa2022926
  • RECOVERY Collaborative Group. Lopinavir–ritonavir in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial. The Lancet [Internet] 2020;396(10259):1345-1352. Available from: https://doi.org/10.1016/S0140-6736(20)32013-4
  • RECOVERY Collaborative Group. Tocilizumab in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial. The Lancet [Internet] 2021;397(10285):1637-1645. Available from: https://doi.org/10.1016/S0140-6736(21)00676-0

 

RECOVERY in Nepal

Description of the team:

RECOVERY in Nepal is being led by the Nepal Health Research Council (NHRC) in collaboration with OUCRU-Nepal. There are currently three active sites in Nepal: Sukraraj Tropical and Infectious Disease Hospital (STIDH),  Armed Police Force (APF) hospital and Nepal Police Hospital (NPH).

The site Principal Investigator for STIDH, APF Hospital and NPH are Dr Anup Bastola, chief consultant of tropical medicine, Dr Roshan Kumar Jha, consultant physician and Dr. Damodar Paudel, head of internal medicine department respectively. .

Prof Buddha Basnyat from OUCRU-Nepal and Dr Pradip Gyanwali from NHRC are the country investigators for this trial.

 

About the Nepal site:

Sukraraj Tropical and Infectious Disease Hospital (STIDH) is the only Infectious & Tropical Disease Hospital established in 1933 in Kathmandu, Nepal. This is the national referral hospital with a capacity of 100 beds inpatient service. It receives patients from all over the country and referred patients from the Valley hospitals. This is one of the main hospitals in Kathmandu valley where patients with COVID-19 are being treated.

Armed Police Force (APF) hospital is a 200-bed government hospital that was dedicated as an anti-coronavirus dedicated facility by the Ministry of Health, Nepal.  Recently another police hospital ( Nepal Police Hospital) has also been added for enrollment of patients. This is also a government hospital which has a capacity of 200 beds.

RECOVERY in Indonesia

This trial will be hosted and led by the Faculty of Medicine, University of Indonesia and supported by the Universities of Indonesia and Oxford Clinical Research laboratory (IOCRL), a joint facility established in 2017 on the faculty’s campus in Central Jakarta, that serves as a hub to support clinical trials, education and public engagement.

The study is being managed by Dr Erni Nelwan (Faculty of Medicine University of Indonesia, FKUI) as the country Principal Investigator, Prof. Raph Hamers (Oxford University, based at FKUI) as the country’s responsible investigator of the trial, and Dr Mutia Radharjani, as the head of the Clinical Research Support Unit at the Eijkman-Oxford Clinical Research Unit (EOCRU).

The trial is recruiting at Martha Friska Hospital, Medan; Metropolitan Medical Centre, Jakarta; Hasan Sadikin Hospital, Bandung; UNAIR hospital, Surabaya; Kandou Hospital, Manado; and other potential sites.

Collaborators: Atika Rimainar, Nunung Nuraeni, Winahyu Handayani 

RECOVERY in Viet Nam

About the Viet Nam sites:

The National Hospital for Tropical Diseases (NHTD), Ha Noi, is a tertiary care centre for infectious diseases in northern Viet Nam. Unlike most hospitals, NHTD is a specialist hospital under the direct supervision of the Ministry of Health.

The Hospital for Tropical Diseases (HTD), Ho Chi Minh City, is the referral hospital for infectious diseases for all of southern Viet Nam.