Wearable tech, AI and clinical teams combine to change the face of clinical trial monitoring
23 January 2023
Publish date: 09 June 2020
UCLH is contributing to a national priority trial of the drug ruxolitinib in patients with Covid-19 pneumonia (infection of the lungs).
The trial, which at UCLH is led by consultant haematologist Dr Mallika Sekhar, is applying a treatment approach known as immunomodulation – aimed at dampening the overactive immune response seen among hospitalised Covid-19 patients – and is in line with UCLH’s interest in this approach.
Ruxolitinib is a well-established drug which inhibits the action of cytokines that are responsible for an overreaction of the immune system called cytokine release syndrome (CRS).
Many patients with severe respiratory (lung) disease due to Covid-19 have features consistent with the CRS, so it is thought that ruxolitinib might also help in Covid-19.
In the trial – sponsored by Novartis – patients diagnosed with Covid-19 pneumonia will be given the drug while they continue to receive the current standard of care. Out of every 3 patients enrolled, two will be randomly assigned to receive ruxolitinib (active) and one will be randomly assigned to receive a placebo (no active drug).
UCLH has recruited its first patient to the study, though recruitment to the study is challenging because of strict criteria around who is eligible for the trial – and due to the welcome fall in the number of Covid patients hospitalised at UCLH since the peak in cases.
After a screening period of assessments, eligible patients take a single tablet twice a day for 14 days. After that the treatment can be extended by a further 14 days if needed. Patients are in the study for a maximum of 29 days.
Dr Sekhar said: “We will be looking at the proportion of patients who go on to develop respiratory failure, whether they need to be admitted to the intensive care unit during their hospital stay and the proportion of patients who succumb to Covid-19. Based on what we know about the drug, there is good reason to believe it will be of benefit in Covid-19, and we hope to be able to demonstrate this.”
23 January 2023
10 January 2023