PHOSP-I
Research type
Research Study
Full title
A phase IIa double blind, randomised placebo-controlled trial of Tocilizumab to investigate the effect on health-related quality of life in adults with Long COVID and persistent inflammation.
IRAS ID
1006298
Contact name
Rachael Evans
Contact email
Sponsor organisation
University of Leicester
Eudract number
2022-003211-29
ISRCTN Number
ISRCTN46454974
Research summary
To date, over 800,000 adults have been admitted into UK hospitals with COVID-19. Only one in three people feel fully recovered one year after discharge. We found that proteins involved in inflammation are higher in adults who have the worst health outcomes. One of these proteins is called ‘interleukin-6’ (IL-6). Tocilizumab is a drug which lowers the levels of IL-6. We are therefore going to test in a research trial whether Tocilizumab can help people with ongoing symptoms (Long COVID) feel better.
People who do not feel fully recovered at recruitment after COVID-19 and have ongoing whole-body inflammation measured by a commonly used blood marker will be invited to take part.
Tocilizumab is used across the world to treat other inflammatory conditions such as rheumatoid arthritis. It is given by an injection under the skin. Side effects from the medication include lowering the immune system and liver problems. Participants at high risk of these problems will be excluded.
152 participants will be put into two groups at random. One group will receive Tocilizumab injections for 12 weeks and the other group will receive placebo injections (sterile solution without the drug). Injections will be weekly or fortnightly depending upon participant’s weight.
The main outcome is a questionnaire to assess how people feel. Other outcomes involve questionnaires to assess symptoms, physical and mental health, an assessment of brain fog, tests of physical performance and activity, and a breathing test. Blood and urine samples will be collected for detailed assessment. After consent and eligibility, there are three main research visits: at the start and end of the treatment period, and 12 weeks after the end of the treatment period. Any adverse events will be reported. Two optional sub-studies involve taking images/scans of the lungs and body organs.
REC name
West Midlands - Edgbaston Research Ethics Committee
REC reference
23/WM/0234
Date of REC Opinion
21 Dec 2023
REC opinion
Further Information Favourable Opinion