A study to evaluate TCZ in patients with severe COVID-19 Pneumonia [COVID-19] [UPH]
Research type
Research Study
Full title
A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE SAFETY AND EFFICACY OF TOCILIZUMAB IN PATIENTS WITH SEVERE COVID-19 PNEUMONIA
IRAS ID
282099
Contact name
Andrew Ustianowski
Contact email
Sponsor organisation
F. Hoffmann-La Roche Ltd
Eudract number
2020-001154-22
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 9 months, 17 days
Research summary
This study aims to see whether treatment with Tocilizumab helps patients with COVID-19. Toclizumab is a medicine that blocks the action of a protein (interleukin-6) involved with the immune system. \n The study will look at how effective and how safe Tocilizumab is compared with placebo (no active ingredient) in patients with COVID-19 pneumonia. The study will enrol 330 patients from 9 countries. In the UK, about 60 patients will take part, from 8 different hospitals. All patients will receive normal hospital treatment as well as one of the following treatments, chosen by chance: Group 1 will receive Toclizumab, given as one or two infusions (into a vein) -there is a 2 in 3 chance of being in this group; Group 2 will receive placebo, given as one or two infusions (into a vein) - there is a 1 in 3 chance of being in this group. Patient information, including blood pressure, pulse rate, temperature, blood oxygen levels, level of consciousness (awareness) and breathing status will be collected daily for 28 days. Weekly Laboratory tests, and swabs from the upper throat, behind the nose (nasopharyngeal) will be collected daily for the first week and then weekly for 28 days. Heart and lungs will be assessed by ECG (electrocardiogram) at screening, Chest X-ray and CT (computerised tomography) scan weekly for 28 days. There will be further assessments on Day 35, Day 45 and when the study finishes on Day 60. The study will also monitor other effects on the body such as C-reactive protein (which is an indicator of the level of inflammation), and how the drug is changed in the body (pharmacokinetics). The study is paid for by F. Hoffmann-La Roche Ltd.
REC name
Yorkshire & The Humber - Leeds East Research Ethics Committee
REC reference
20/YH/0222
Date of REC Opinion
1 Apr 2020
REC opinion
Favourable Opinion