University researchers and NHS staff, in Cambridge and across the UK, rally together to rapidly set up clinical trials to find new treatments for patients with COVID-19.
Researchers and technicians locked out of their labs due to restrictions to control the spread of the virus are among the army of scientists in Cambridge redirecting their knowledge and skills to fight the new disease.
They are joining forces with research nurses, clinical trial coordinators, pharmacists and doctors to launch new clinical trials for COVID-19 in record time.
The NIHR Cambridge Biomedical Research Centre, NIHR Clinical Research Facility and NIHR Clinical Research Network have worked with a diverse and large group of researchers to rapidly establish a collaborative governance infrastructure - called the Clinical Research Oversight Group - for delivery of nationally prioritised COVID-19 clinical trials for patients in Cambridge.
The group, chaired by Professor John Bradley, includes Dr Martin Knolle, consultant in respiratory medicine, Dr Mark Toshner, University Lecturer and consultant in respiratory medicine, and Professor Grant Stewart, kidney cancer surgeon and Chair of Surgical Oncology.
Dr Sarah Burge, CRUK Cambridge Centre Urological Malignancies Programme Manager, who is coordinating the operations and logistics for the group has been inundated with offers of help from across the Cambridge scientific community.
Over 80 local professionals came together to launch the first clinical trial, the RECOVERY trial, recruiting their first patients at Addenbrooke’s and Royal Papworth Hospitals last week. The meticulous processes and protocols that would usually take 6-12 months to get a clinical trial off the ground were completed safely in just 9 days.
Dr Robert Rintoul, Principal Investigator for RECOVERY at Royal Papworth Hospital said: “We are delighted to be participating in this important national research effort to try and identify new effective treatments for COVID-19 as quickly as possible.
"Research and development teams at Royal Papworth and many other hospitals in the East of England and beyond have worked around the clock to set up and open this study so quickly.”
Patients at the participating Trusts who test positive for COVID-19 will be invited to join the RECOVERY trial to test whether drugs already developed for different diseases, such as HIV and lupus, could be used to treat the coronavirus COVID-19 disease.
The trial, which is led from Oxford University, will assess and compare the effectiveness of three different combinations of drug treatment for COVID-19 patients, in addition to their usual standard care.
“It would be a game changer if we can figure out a treatment that either slows progression or ideally reduces the intensity of the disease." said Dr Toshner.
"It really is absolutely critical at this stage.”
After 28 days all patients on the trial, whether they received one of the three drug combinations, or received no additional treatment as a control sample, will then be assessed. The adaptive trial design allows promising new drugs to be included in the trial, providing great flexibility.
“It’s an adaptive trial – what that means is that as we accummulate evidence if drugs are working we can prioritise them, and they’re if not we can drop them. If new drugs come online they can just get plugged into the programme,” explained Dr Toshner.
Over 100 hospitals across the country are signed up to open the RECOVERY trial as soon as they can. The results from all trial patients will be analysed throughout the trial period to find out which treatment is most effective against COVID-19.
Dr Martin Knolle, Principal Investigator for RECOVERY at Addenbrooke's Hospital said: "This is an example of Cambridge researchers, as part of a national effort, pulling together to deliver potentially life-saving treatments in record time in the most difficult of circumstances. I am very proud of our team and research community for this response.”