Early findings show that tocilizumab, an immunosuppressive drug used to treat rheumatoid arthritis, reduces inflammation in critically ill patients with Covid-19.
The research from the REMAP-CAP trial, led by Imperial College London and the Intensive Care National Audit & Research Centre (ICNARC) in the UK and Utrecht University in Europe, evaluated the effect of treatments on a combination of survival and length of time patients need support in an intensive care unit (ICU).
Patients receiving tocilizumab were more likely to improve (measured by a combination of organ support, such as a breathing machine, in the ICU and surviving the hospital admission) compared to patients who received no immune modulator.
Due to the clinical implications for patients, the researchers released the findings before they have been peer-reviewed.
Further data are expected in the coming weeks and months such as the relative contribution of survival and reduced length of time needing organ support in ICU and the relative benefits of tocilizumab compared to the other immune modulators.
Tocilizumab could improve the outcomes of the sickest Covid-19 patients
Professor Anthony Gordon, Chair in Anaesthesia and Critical Care at Imperial College London and a Consultant in Intensive Care Medicine at Imperial College Healthcare NHS Trust, said: "These early findings show that treatment with this immune modulating drug is effective for critically ill Covid-19 patients in intensive care units. When we have the results available from all participants, we hope our findings will offer clear guidance to clinicians for improving the outcomes of the sickest Covid-19 patients."
The latest analysis was carried out by a Statistical Analysis Committee separate from the trial investigators and reviewed by an independent Data and Safety Monitoring Board (DSMB) on 17th November. The analysis included data from the first 303 patients randomised to receive immune modulation treatments: tocilizumab, sarilumab, anakinra, interferon, or no immune modulator.
The trial data yielded an estimated odds ratio of 1.87 for a better outcome with tocilizumab compared to no immune modulation, with a high degree of statistical certainty (99.75% probability that tocilizumab is superior to no immune modulation).
REMAP-CAP began investigating treatments for Covid-19 in March 2020, enrolling hospitalised patients with either moderate or severe (requiring ICU care) Covid-19 disease. The study design randomises patients to multiple combinations of treatments, enabling researchers to evaluate different treatments for COVID-19, including antivirals, drugs which modulate the immune response, and therapies that modulate or support other vital aspects of the body's response to the virus.
In total, over 2,000 patients in 15 countries have been enrolled at more than 260 hospitals worldwide and randomised to multiple treatment combinations. The effects of interventions are assessed separately for moderate and severely ill patients.
The latest findings on tocilizumab and lopinavir/ritonavir add to REMAP-CAP findings from earlier this year, which found that hydrocortisone steroid treatment improved recovery among critically ill COVID-19 patients.