Royal Bolton Hospital plays crucial role in COVID drugs trial

Royal Bolton Hospital has played a vital role in developing safe and effective COVID-19 treatments by participating in a so-called mega-trial of existing drugs, looking for therapies for the coronavirus infection.

Royal Bolton was selected as one of 176 NHS hospitals as part of University of Oxford’s ‘Recovery’ trial which has been measuring the effectiveness of a number of medicines.  To date, over 12,000 patients have been recruited nationally to the trial.

The ‘Recovery’ (Randomised Evaluation of COVID-19 therapy) trial has received global recognition for its speed and effectiveness,  with the centralised NHS system providing a solid basis for a large randomised trial, compared to other health institutions across the world, which are often more fragmented, and unable to deliver conclusive evidence.

Bolton’s own role in the trial has seen the development of dexamethasone as an effective treatment for COVID-19 patients, with the relatively cheap steroid reducing deaths by one third in ventilated patients, and by one fifth in those on oxygen alone.

Speaking about Royal Bolton Hospital’s participation in the Recovery trial, Clinical Trials Pharmacist, Karen Lee said: “It’s a race against time to recruit patients to the trial during the peak of infection so that we can get results as soon as possible to provide evidence-based treatments.

“A trial like this has been unprecedented; we have had to work at an unbelievable rate to set-up the trial and recruit the first patient within two weeks of being notified, a process which usually takes months to a year to achieve.

“One arm of the trial [tocilizumab] was only made available to 80 of the 176 hospitals selected, which is testament to the hard work the Bolton team have put into getting the trial running.  During the first weeks of recruitment, our recruitment rate was higher than the national average, which put us in a good light to be considered to facilitate additional treatments, and thereby increase access of a variety of trial medications to our COVID patients.”

The Recovery trial is on-going at Royal Bolton Hospital, with a number of other drugs being trialled for safety and efficacy in the battle against COVID-19.

Dexamethasone was a success, while the trial confirmed that the use of hydroxychloroquine (an antimalarial drug) and lopinavir-ritonavir (a drug used in HIV) did not provide additional benefit.  The medications still available to patients recruited to the Recovery trial now consist of azithromycin (a commonly-used antibiotic), tocilizumab (an antibody medication used in rheumatology patients) and convalescent plasma (antibody-rich blood plasma donated by recovered COVID-19 patients).

“By confirming that prospective drugs provide no additional help in treating COVID patients, we can focus on using effective treatments and stop using medications which have no proven benefit, which is equally important in developing national guidance and conserving resources,” Karen Lee said.

Royal Bolton Hospital will continue participating in the Recovery trial, while numbers of COVID positive patients decline and in preparation for a second wave, but by combining her role as the Trust’s Clinical Trials Pharmacist with her speciality role in respiratory medicine, Karen Lee is certainly seeing first hand evidence of the benefits of the trial.

“I certainly feel very proud.  It has been a tough time, and because we are a small Clinical Trials Pharmacy team, there was a lot of work for the few of us involved.  I cover the respiratory wards so I have been able to see patients from a trials and a respiratory perspective.  By seeing and reviewing patients on the ward, I have been learning the pattern of how COVID-19 develops and have also been able to identify those who would benefit by being enrolled into a COVID trial.

“It has been a learning curve for everyone and it does give you that sense of achievement when there are positive results published to allow patients to be treated with medications proven to work.  Especially when a patient receiving one of these treatments is stepped down from critical care, and you can see them visibly get better and sent home, we can see how it is making a real difference.”

Aside from the Recovery trial, Royal Bolton is also implementing the use of Remdesivir, an anti-viral drug which was recommended by NHS England, after clinical trials showed an improvement in recovery time in patients hospitalised with coronavirus disease.

More recently, the Catalyst trial has been set up at Royal Bolton, which looks at using treatments including antibody medications.  The main aim of the trial is to gather good quality preliminary data on patient outcomes as a result of treatment so that the trial medication can be studied at a much larger scale.

Karen Lee said: “There might be a second peak and you never know what could happen in the winter time. It is still important to keep recruiting patients and participate in a lot of different trials, to see whether there is a better medication out there.”

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