About the trial

The CATALYST Trial will test new therapies for patients hospitalised due to suspected or confirmed severe COVID-19. Researchers want to know treatments that could reduce the severity of COVID-19 when compared with the usual care given in the NHS.

COVID-19 is an illness caused by infection with the virus known as Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2). Infection with SARS-CoV-2 causes a spectrum of illness that ranges from mild to life-threatening disease. It is believed that our body’s overwhelming immune response to the virus may be a critical factor in the development of severe COVID-19. It is hoped that the drugs that reduce this abnormal immune response can mitigate the severity of COVID-19. This would lead to a reduction in the number of patients requiring intensive care treatment, a reduction in the severity of lung failure and, ultimately, a decrease in virus-related deaths.

Background to the trial

In late 2019 unusual cases of pneumonia were identified to be the result of a previously unknown type of coronavirus (SARS-CoV2), which causes the disease known as Coronavirus disease 2019 (COVID-19). Pneumonia is an infection of the lungs that causes the lungs' air sacs to become inflamed and fill up with fluid. These processes can make it difficult for the patients to breathe and for the oxygen they inhale to be delivered to the bloodstream effectively. COVID-19 is an infectious disease capable of person-to-person transmission and quickly spread worldwide. On January 30th 2020, the outbreak was declared a Public Health Emergency of International Concern (PHEIC). By the end of March 2020, the mortality rate for hospital admissions in the UK was 5.2%, raising up to 50% for those admitted to an Intensive Care Unit (ICU) and leading to an unprecedented challenge for our health and care services.

Given the novelty and severity of COVID-19, in early February, 2020, UK Research and Innovation (UKRI) and the National Institute of Health Research (NIHR) launched a joint strategic initiative to develop understanding, diagnosis, prevention, and treatment of COVID-19. Although rapid advances have led to treatment options, such as steroids, still the chance of critical illness and death is  high. It is imperative that more treatment options are discovered and developed as fast as possible. One source of potential treatments are drugs that are already designed and available in other disease areas.

As COVID-19 is a new illness, we are constantly learning more about how it affects the human body. We know that the virus responsible for causing COVID-19 affects several different cells in your body, including immune system cells called monocytes and macrophages. COVID-19 can cause the number of these cells to increase and to become highly activated. To fight an infection, your immune cells produce proteins called cytokines and chemokines. These proteins can cause inflammation and at high levels they can lead to damage in the tissues and organs of your body. Researchers believe this is why some people with COVID-19 infection become very ill. The current drugs used in CATALYST aim to prevent the potential damage to a patient’s tissues and organs by either:

  • Preventing the number of highly activated macrophages from increasing and causing inflammation, or
  • Blocking the effects of a key inflammatory cytokine that they produce.

Trial design

CATALYST is an exciting, new, adaptive trial designed to rapidly test promising drugs and treatment options that are currently available, and to assess their safety and potential efficacy. Patients with suspected or confirmed COVID-19 will be randomly computer-allocated to receive either their usual care or their usual care plus the addition of one of the trial drugs.

Drugs that show promising results will then be considered for larger-scale testing by one of the current national platform trials (RECOVERY or REMAP-CAP). The design of the CATALYST trial is such that new therapies can be introduced sequentially, based on secure laboratory science and clinical outcomes. In this way, CATALYST acts as both a filter and a “spring-board” for future high-quality therapies. It simultaneously discounts unsuitable agents whilst providing promising drugs with a quick and smooth transition into phase III (large scale) trials. In doing this, CATALYST helps meet the need for high-throughput screening (to identify promising COVID-19 treatments) as well as the necessity to get effective therapies to patients as quickly as possible.

Treatments currently being tested

Therapies we are testing:

A new, unlicensed drug called Namilumab that has been tested in patients with rheumatoid arthritis and other inflammatory conditions. It may reduce the numbers of highly activated inflammatory macrophages in the lungs and thereby dampen the inflammation in the body caused by the coronavirus. Our Namilumab Arm has closed and we are no longer recruiting patients to Namilumab.

A drug called Infliximab (Remsima), which is widely used to treat rheumatoid arthritis and other inflammatory conditions such as Crohn’s Disease. It blocks the action of a critical cytokine, known as TNF, which is produced by activated macrophages and drives inflammation. In doing this, Infliximab may reduce inflammation in the body caused by the coronavirus. Our Infliximab Arm has closed and we are no longer recruiting patients to Infliximab.

By reducing the excessive inflammation that occurs in patients with more severe COVID-19, it is thought the immune system will adapt to fight off the virus more effectively.

What will happen to the results of the research trial?

At the end of the trial, the findings will be published in peer-reviewed medical and scientific journals. They may also be presented at scientific meetings. These publications will be available upon request from your trial team. We will also make a lay summary of the result available here.

How to get involved

For more information on how to get involved, and for a list of which hospitals are currently recruiting patients to this trial, please visit our How to get involved page

Please note, the CATALYST trial is now closed to recruitment.