A new nationwide clinical trial, funded by the National Institute for Health Research (NIHR) and the NIHR Cambridge Biomedical Research Centre and led by University of Cambridge, seeks to cut down the number of patients being readmitted to the hospital with complications as a result of having already been infected with SARS-CoV-2, the virus behind COVID-19. The study includes the Clinical Trials Centre associated with the University of Liverpool as well as British remote patient monitoring technology venture Aparito. According to one of the participating investigators, the UK’s NHS has been at the forefront of fighting the war on COVID-19 with its supported breakthrough involving dexamethasone and now leads the way in the investigation targeting treatments for the after-effects of COVID-19.
In the UK, that country’s Office for National Statistics reports that 29% of COVID-19 hospitalized patients were actually readmitted within six months. 12% of this population actually died in this same period.
Known as “Helping to Alleviate the Longer-term Consequences of COVID-19” (HEAL-COVID), the study will be executed in collaboration with the Liverpool Clinical Trials Centre at the University of Liverpool and Wrexham-based clinical trial technology venture known as Aparito.
The study team will investigate a selection of safe, existing drugs already on the market on patients across the UK to find more effective treatments.
TrialSite offers a breakdown of this National Health Service-funded clinical trial targeting patients with Long-Covid that are readmitted into the hospital after hospitalization.
What is the core problem here?
According to British statistics, 29% of those individuals hospitalized due to SARS-CoV-2 infection find themselves back in the hospital and unfortunately 12% go on to die. The study aims to inquire how to turn this around.
Is this trial the first of its kind?
Yes. According to the recent entry from University of Cambridge and a declaration from Dr. Charlotte Summers, University of Cambridge and Addenbrooke’s Hospital, this trial is “…the first of its kind to look at what drugs we could use to reduce the devastating impact on patients” associated with this readmission problem.
What drugs are involved?
Two initial drugs have been identified, and a third may be selected based on a recommendation by the UK COVID Therapeutic Advisory Panel. Apixaban is sold under the trade name Eliquis among others and is an anticoagulant medication used to treat and prevent blood clots to prevent stroke in people with nonvalvular atrial fibrillation. The other drug involved is Atorvastatin, typically prescribed alongside diet to help reduce “bad” cholesterol and fats (such as LDL, triglycerides) and increase “good” cholesterol (HDL). This belongs to a class of drugs known as statins and work to reduce the amount of cholesterol produced by the liver.
What is the UK COVID Therapeutic Advisory Panel?
The UK Therapeutic Advisory Panel also known as “UK-CTAP” is an independent group chaired by Professor Patrick Chinnery advising the government on treatments proposed for testing via the RECOVERY+, REMAP-CAP, PRINCIPLE and AGILE trials out of the UK. The claim here is that the panel is formed by a group of experts with “no vested interests.”
UK-CTAP is supported by a UK Research and Innovation (UKRI) led secretariat. For membership list, follow the link.
How will the study work?
The HEAL-COVID study team will identify patients as they are discharged rom the hospital following their first admission for COVID-19. Upon acceptance the subject will be randomized and given one of two drugs—either apixaban or atorvastatin—and then track the patients progress.
Can the study add or remove treatment options?
Yes. Designed with flexibility in mind, Professor Carrol Gamble directs the Liverpool Clinical Trials Centre and reports that the trial is designed to facilitate flexibility, that is they can “remove or add-in treatment options in response to patient outcomes.”
Is the study integrated into the clinic workflow?
Yes as much as possible, the key here is to meld clinic health care professional and patient experience to “minimize burden on NHS staff and patients” hence representing “a true team approach to science,” according to Professor Gamble.
Why is the UK’s NHS important in the war on COVID-19?
Because as Professor Stephen Powis, NHS medical director, declared in the University of Cambridge news entry, “The NHS led the world in research identifying dexamethasone as the first treatment in the world for COVID-19 and this latest trial could help discover new treatments for the after-effects of COVID-19, helping to rapidly get world-leading therapies to our patients.”
What is NHS doing about Long COVID?
Professor Powis the national British health system has invested millions into opening up “dozens of dedicated clinics to help people get back to good health.” For the American audience, the NHS (National Health Service) is the umbrella term for the publicly funded healthcare systems of the United Kingdom (UK). Set up after the devastation of World War 2 in 1948, they system was funded out of general taxation. There are actually three systems which make up the NHS including NHS England, NHS Scotland and NHS Wales. A separate system is available in Northern Ireland called Health and Social Care.
Is the NHS Social Medicine?
Yes. The founding principles of the NHS include the offer of comprehensive, universal and free health at the point of delivery, a health service based on clinical need, not the ability to pay.
What does Aparito do?
Remote patient monitoring technology vendor based in Wrexham, England south of Liverpool. Aparito was founded in 2014 by Dr. Elin Haf Davies to positively impact patient lives. Early on as a pediatric nurse, she experienced first hand the often redundant time consuming, and even painful tests carried out in order to monitor patients taking part in clinical trials. She took her years of practical experience and designed what is described as a patient-centric, remote monitoring solution with the healthcare provider in mind to support clinical research.
Dr. Charlotte Summers, University of Cambridge and Addenbrooke’s Hospital
Professor Carrol Gamble, Head of the Department of Biostatistics and the Director of the Liverpool Clinical Trials Centre
Call to Action: TrialSite will monitor this important study using anticoagulant and statin drugs to target LONG COVID patients and hospital readmission. A third drug will be selected as well.