Researchers from the University of Oxford have launched a new clinical trial to test the effects of potential drug treatments for patients admitted to hospital with COVID-19. The first patients have now been recruited.
There are currently no specific treatments for COVID-19. It is possible that some existing drugs usually used for other conditions may have some benefits, but they may not.
The trial will provide doctors and the health service with information they need to determine which treatments should be used.
The treatments initially included in the study have been recommended by an expert panel that advises the Chief Medical Officer in England.
These are Lopinavir-Ritonavir, normally used to treat HIV, and the steroid dexamethasone, which is used in a wide range of conditions to reduce inflammation. The safety and side effects of both drugs are well known. In the future, the trial will be expanded to assess the impact of other potential treatments as they become available.
The chance to join the trial will be offered to adult inpatients who have tested positive for COVID-19 in NHS hospitals, and who have not been excluded for medical reasons. All patients will receive the usual standard of care. Patients joining the trial will be allocated at random by computer to receive one of the two drugs being studied or no additional medication. This will enable researchers to see whether any of the possible new treatments are more or less effective than those currently used for patients with COVID-19.
Peter Horby, Professor of Emerging Infectious Diseases and Global Health in the Nuffield Department of Medicine, University of Oxford, and Chief Investigator for the trial, said ‘There is an urgent need for reliable evidence on the best care for patients with COVID-19. Providing possible new treatments through a well-designed clinical trial is the best way to get that evidence. Adults admitted to hospital with COVID-19 should be offered the opportunity to participate in this trial and contribute to improving care for everyone. All patients will receive the standard full medical care, regardless of which treatment group they are placed in.’
Martin Landray, Professor of Medicine and Epidemiology at the Nuffield Department of Population Health, University of Oxford, and Deputy Chief Investigator added: ‘The streamlined design of this clinical trial allows consenting patients to be enrolled in large numbers easily and without compromising patient safety or adding significantly to the workload of busy hospitals and their staff. In this way we can rapidly assess the value of potential treatments for COVID-19 and provide reliable information on the best ways to treat patients with this disease.’
The new trial has been classed as an Urgent Public Health Research Study. It is one of a round of projects to receive £10.5 million as part of the £20 million rapid research response funded by UK Research and Innovation, and by the Department of Health and Social Care through the National Institute for Health Research.
Chief Medical Officer Professor Chris Whitty and NHS England Medical Director Professor Stephen Powis have written to NHS trusts in England asking them to fully support the new trial.