Innovative COVID-19 cell therapy trial – in the researcher’s words

illustration of coronavirus cells

Research nurse Samantha Caddick and clinical trials coordinator Salma Kadiri, both working at UHB’s Heartlands Hospital in Birmingham, relive the moment they recruited the first patient on an innovative cell therapy trial for COVID-19. Their blog is part of the NIHR’s COVID-19 Research Voices series.

We will never forget our first time entering the intensive care unit on the day we recruited our first patient to the REALIST trial.

Both of us got changed into our PPE in the theatres corridor area at Heartlands Hospital – normally a busy place with the hustle of theatre staff. But that day it was eerily quiet.

We were both nervous as it was our first time in full PPE in the Intensive Therapy Unit (ITU) since the crisis began and because we wanted to do well for the patient and for the study.

The first patient was recruited on a bank holiday, so every team on the trial had forfeited their day off to come in and deliver the study. This showed our passion for this remarkable trial.

Rising to the challenge

Prior to COVID-19 we both worked in Thoracic Surgery research, but were then thrust into the world of COVID research while others in our team were redeployed to other areas such as ITU and Bereavement.

We were given the task of working out the logistics of running the REALIST trial. Originally REALIST involved studying the effectiveness of allogenic Mesenchymal Stromal Cells (MSCs) in treating patients with Acute Respiratory Distress Syndrome (ARDS) in ITU. But it was adapted due to the pandemic to include patients diagnosed with COVID-19. The team were excited to rise to the logistical challenge of setting up the study. The main challenges included the timing of  infusion delivery to ensure we did not miss the 72 hour deadline from diagnosis of ARDS.

The secret to our success in recruiting the first patient was effective communication between our multi-disciplinary team. We informed the pharmacy team in advance of any potential cases, and had to ensure that the Advanced Therapies NHS Blood and Transplant (NHSBT) team were able to deliver the product for transfusion on the date of randomisation. We screened the ITU list, however it was just our luck that the day of the first recruit landed on a Bank Holiday! We checked their eligibility, re-checked eligibility with ITU consultants, and then got consent from the patient’s family to allow the patient to take part – then it was all systems go! The patient was randomised to either receiving MSCs or the placebo. We were all blinded apart from the pharmacy team, and therefore didn’t know what the patient had received. 

Working together

While delivering the transfusion, the ITU team were very accommodating and supportive of the trial, collecting observation data at set time points for the research team. We also witnessed the ITU team proning our patient which was a remarkable thing to see – with the steady, calm hands of the nurses and doctors working together to move the patient, interacting through gestures and facial expressions through the layers of PPE, swiftly, in synch. Once the transfusion was delivered we had our fingers crossed that the patient would start showing signs of recovering during that week.

The patient we recruited during the peak of the crisis was the first successful Advanced Therapy Investigational Medicinal Product (ATIMP) research recruit.

In times of need to help our patients, we put our best foot forward – it was a collaborative effort between teams that have never met before, ensuring we delivered the best possible care.

Lubna Khan, a clinical trials pharmacist at Heartlands, continues:

Our pharmacy procedures were especially put to the test during the pandemic with most of our team redeployed. There were also logistical challenges of this study that needed to be considered. In order to help us initially identify and overcome these, we took part in a dummy run – akin to rehearsals before a play! This ensured when we recruited our first patient everyone was able to play their role in achieving a successful delivery.

Visiting NHSBT and understanding stem cell production and delivery of the ATIMP certainly benefited us. The input of the ITU Research nurses into how the ATIMP would be received into ITU by the Pharmacy trials team was invaluable.

A huge acknowledgement and thanks goes to NHSBT and the ITU research team for the initial preparation of this trial. The newly put together COVID Research team were also superb at working with us to adapt the procedures while we delivered this study at the height of the pandemic.

The foundations to convert this study successfully to a COVID research study in a small space of time were down to having good rapport, team work and communication. This was truly a shining example of how a multi-disciplinary team can work collaboratively in helping patients receive the best possible care.

The REALIST trial is led by researchers at Queen’s University Belfast. It is one of a number of COVID-19 studies that have been given urgent public health research status by the Department of Health and Social Care. It is supported by the NIHR Clinical Research Network (CRN), funded by the Health and Social Care Research & Development Division Northern Ireland and the Wellcome Trust, and sponsored by the Belfast Health and Social Care Trust.

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