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Contact Information:

Mrs Victoria Harris
+44 (0)116 250 2670
phosp-i@leicester.ac.uk


Dr Rachael Evans
+44 (0)116 0300 030 1573
phosp-i@leicester.ac.uk


More information about this study, what is involved and how to take part can be found on the study website.

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Be Part of Research - Trial Details - A research trial to find out if tocilizumab helps adults with Long Covid feel better
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A research trial to find out if tocilizumab helps adults with Long Covid feel better

Recruiting

Open to: All Genders

Age: Adult

Cambridge Oxford Sheffield Birmingham Glasgow London London London Leicester Manchester Salford

Medical Conditions

Long COVID

This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


To date, over 1 million adults have been admitted into UK hospitals with COVID-19. Approximately only one in three people feel fully recovered 1 year after discharge. There are an estimated 2 million people living with Long Covid. Previous research has shown 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. The aim of this study is to test whether tocilizumab can help people with ‘inflammatory’ Long Covid feel better.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

01 Feb 2024 31 Aug 2025

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 the participant’s weight. The main outcome is a questionnaire to assess how people feel related to their health. 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, and more detailed breathing tests.


People who do not feel fully recovered at least 3 months after COVID-19 and have ongoing whole-body inflammation measured by a commonly used blood marker

You can take part if:



You may not be able to take part if:


Current exclusion criteria as of 16/01/2025:

1. Other comorbidity indicating survival at one year from consent is unlikely2. Active malignancy or on treatment for malignancy3. Unable or unwilling to provide written consent4. Inability to comply with protocol-directed procedures and assessments5. Current immunosuppression therapy including oral corticosteroids6. Prior use of the trial drug within 3 months of consent (including intra-venous Tocilizumab for acute COVID). 3 months is five-half lives of tocilizumab7. Involvement in other trials involving an IMP either concurrently or within four months of consent - to allow washout. This includes medications prescribed for acute COVID studies.8. Previous adverse event to tocilizumab, either a severe allergic reaction or deranged liver function tests9. Hepatic transaminases greater than three times the upper limit of normal10. Low neutrophil (below 2 x 109/L) or low platelet levels (below 100 x 10e3/μL)11. Signs of active infection12. Receipt of live vaccine within 3 months or planning a live vaccine during the trial period. Most COVID vaccines are not live.13. Pregnancy or breastfeeding, or planning a pregnancy during the trial period or unable or unwilling to meet the contraception criteria (see below)14. Latent TB: to be excluded with IGRA testing and if positive exclude and refer for treatment as per national guidelines.15. New diagnosis or on treatment for HIV16. Past history of diverticulitis17. Significant alcohol or substance misuse18. History of clinically significant hypersensitivity reaction or significantly deranged liver function tests with other medication19. Hepatitis B20. Exclude Hepatitis C if untreated: on testing antibody positive and detectable viral load. If antibody positive, but viral load negative compatible with previous infection only participant can be included.21. Supervised exercise rehabilitation programme including exercise training, or other rehabilitation therapy for example fatigue management or breathing retraining lasting for a minimum of 4 sessions within three months of consent or planned to occur during the trial period22. New medication for Long Covid symptoms started within six weeks of consent23. No new weight management medication to start within three months of consent or during the trial period, for example glucagon-like peptide-1 receptor agonists (GLP-1 RAs) and sodium-glucose cotransporter-2 (SGLT2) inhibitors

_____

Previous exclusion criteria:

1. Other comorbidity indicating survival at one year from consent is unlikely2. Active malignancy or on treatment for malignancy3. Unable or unwilling to provide written consent4. Inability to comply with protocol-directed procedures and assessments5. Current immunosuppression therapy including oral corticosteroids6. Prior use of the trial drug within 3 months of consent (including intra-venous Tocilizumab for acute COVID). 3 months is five-half lives of tocilizumab7. Involvement in other trials involving an IMP either concurrently or within four months of consent - to allow washout. This includes medications prescribed for acute COVID studies.8. Previous adverse event to tocilizumab, either a severe allergic reaction or deranged liver function tests9. Hepatic transaminases greater than three times the upper limit of normal10. Low neutrophil (below 2 x 109/L) or low platelet levels (below 100 x 10e3/μL)11. Signs of active infection12. Receipt of live vaccine within 3 months or planning a live vaccine during the trial period. Most COVID vaccines are not live. 13. Pregnancy or breastfeeding, or planning a pregnancy during the trial period or unable or unwilling to meet the contraception criteria (see below)14. Latent TB: to be excluded with IGRA testing and if positive exclude and refer for treatment as per national guidelines. 15. New diagnosis or on treatment for HIV16. Past history of diverticulitis 17. Significant alcohol or substance misuse 18. History of clinically significant hypersensitivity reaction or significantly deranged liver function tests with other medication 19. Hepatitis B20. Exclude Hepatitis C if untreated: on testing antibody positive and detectable viral load. If antibody positive, but viral load negative compatible with previous infection only participant can be included. 21. Supervised exercise rehabilitation programme within three months of consent or planned to occur during the trial period


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Cambridge University Hospitals NHS Foundation Trust
    Addenbrookes Hospital Hills Road
    Cambridge
    CB2 0QQ
  • Oxford University Hospitals NHS Foundation Trust
    John Radcliffe Hospital Headley Way Headington
    Oxford
    OX3 9DU
  • Sheffield Teaching Hospitals NHS Foundation Trust
    Northern General Hospital Herries Road
    Sheffield
    S5 7AU
  • University Hospitals Birmingham NHS Foundation Trust
    Queen Elizabeth Hospital Mindelsohn Way Edgbaston
    Birmingham
    B15 2GW
  • Glasgow Royal Infirmary
    84 Castle Street
    Glasgow
    G4 0SF
  • Kings College Hospital
    Denmark Hill
    London
    SE5 9RS
  • Guy's & St Thomas Hospital
    Westminster Bridge Road
    London
    SE1 7EH
  • NIHR University College London Hospitals Clinical Research Facility
    University College London Hospitals NHS Foundation Trust 4th Floor 170 Tottenham Court Road
    London
    W1T 7HA
  • University Hospitals of Leicester NHS Trust
    Glenfield Hospital Groby Road
    Leicester
    LE1 5WW
  • Manchester University Hospitals NHS Foundation Trust
    Wythenshawe Hospital Southmoor Road Wythenshawe
    Manchester
    M23 9LT
  • Northern Care Alliance NHS Foundation Trust
    Salford Royal Hospital Stott Lane Eccles
    Salford
    M6 8HD

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. This trial is categorised as Type B = somewhat higher than the risk of standard medical care. The study is using tocilizumab out of current clinical indications and licensing. However, tocilizumab at the dose we are proposing is currently used safely in other long-term conditions where IL6 is raised and part of the underlying inflammatory pathway causing disease.
Current standard practice for Long COVID involves no medication specifically for the Long COVID disease process and specifically no anti-interleukin (IL) 6 agents. Therefore, any side effects of the medication are above the risk of standard medical care for Long COVID. There is no indication that patients with Long COVID would have a higher risk of side effects than other patient populations.
A comprehensive compilation of clinical and nonclinical data on tocilizumab is available in the Investigators Brochure. The main side effects are:
Very common (>10%): upper respiratory tract infections, injection site reaction
Common (10%-1%): cellulitis, oral herpes simplex, Herpes zoster, abdominal pain, mouth ulceration, gastritis, rash, pruritus, urticaria, headache, dizziness, increased hepatic transaminases, increased weight, hypertension, leucopenia, neutropenia, hypercholesterolemia, peripheral oedema, hypersensitivity reaction, cough, dyspnoea, conjunctivitis
Uncommon (<1%): diverticulitis, stomatitis, gastric ulcer, increased total bilirubin, hypertriglyceridemia, nephrolithiasis, hypothyroidism
The researchers will mitigate these as far as possible by excluding participants that would be high risk of side effects and by careful monitoring of potential side effects which can be measured through serial blood tests. The main side effects are neutropenia (a low type of white cell count), thrombocytopenia (low platelet count) and hepatitis (liver inflammation), therefore blood tests of neutrophils, platelets and liver function tests will be monitored every 4 weeks. Specific and clear dose adjustments are provided in the protocol based on the tocilizumab investigator brochure (IB).
There is no data to support the safety of tocilizumab during pregnancy to date and therefore for this trial the assumption is Tocilizumab is not safe during pregnancy and therefore any participant or participant’s spouse who is either pregnant or planning a pregnancy in the same timeframe would be excluded. Pregnancy tests (urine) will be performed at each visit. A serum pregnancy test will be performed at screening.

Dr Rachael Evans
+44 (0)116 0300 030 1573
phosp-i@leicester.ac.uk


Mrs Victoria Harris
+44 (0)116 250 2670
phosp-i@leicester.ac.uk



More information about this study, what is involved and how to take part can be found on the study website.


The study is sponsored by University of Leicester and funded by Genentech Roche.



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Read full details for Trial ID: ISRCTN46454974

Or CPMS 60222

Last updated 16 January 2025

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