A phase IIa double blind, [RCT] of Tocilizumab to investigate the effect on [HRQOL] in adults with Long COVID and persistent inflammation (PHOSP-I)

[Yann04]

Edit:
Full title of trial, led by Leicester University, UK:
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 (PHOSP-I)
_____________

UK BBC: Long Covid study could give Leicester sufferer 'life back'

https://www.bbc.com/news/uk-england-leicestershire-68929633.amp

Clare Elliott, 33, contracted Covid-19 in February 2020 and has suffered symptoms ever since.

She has joined a study launched by the University of Leicester testing the effectiveness of drug tocilizumab.

Associate professor Dr Rachael Evans said the drug could improve the quality of life for those who have long Covid.


Long Covid - symptoms lasting at least 12 weeks after a Covid infection - is thought to have affected millions of people around the world.

Tocilizumab may be effective in treating patients by reducing inflammation, thereby improving symptoms such as fatigue, breathlessness, brain fog and pain.

Ms Elliott, from Glenfield, said she hopes the study will help alleviate some of her symptoms. The research will involve 152 patients at 15 different sites across the UK, including Nottingham University Hospitals NHS Trust.

"It's now impacted every part of my life - even being able to leave the house," said Ms Elliott.

"I've got breathing issues, heart rate issues, cognitive issues, fatigue. Every part of my body is impacted.

"I just hope the study will help ease some of the symptoms so that I can get some of my life back and that it might help lead to other discoveries to help people with long Covid.

"There are so many of us out here suffering, and we need some help."
​

 

[Yann04]

I know they took it from a patient’s quote but the “life back” headline bothers me a little, atleast seems to me to make the assumption people with long covid don’t have a life. Of course I’m typing this while bedridden and socially isolated, but I would find it insulting if I was told I “didn’t have a life”.

 

[Jonathan Edwards]

I wonder who is running this?
152 patients sounds like a serious controlled trial, presumably double blind.
I suspect nothing much will be found in the way of effect but it will be interesting even if not.

 

[Nightsong]

I wonder who is running this?
152 patients sounds like a serious controlled trial, presumably double blind.
I suspect nothing much will be found in the way of effect but it will be interesting even if not.

Looks like the PHOSP-I trial:

https://www.phosp.org/phosp-i/
https://leicesterbrc.nihr.ac.uk/first-participant-phosp-i/
https://bepartofresearch.nihr.ac.uk/trial-details/trial-detail?trialId=49777&location=the UK&distance=
https://www.isrctn.com/ISRCTN46454974

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.
...
1. Age ≥18 years old and ≤80 years old
2. Clinical diagnosis of COVID-19 at least 3 months prior to consent. Patient-reported positive test is acceptable
3. Patient does not feel fully recovered at recruitment after COVID-19 (response no or unsure to “do you feel fully recovered from your COVID-19”)
4. CRP >5 mg/L persistently raised after contracting COVID-19 and prior to randomisation
5. Euroqol EQ5D-5L utility index ≤0.90 units prior to randomisation
6. Reasonable understanding of the English language assessed by the research team (i.e. able to understand the risks of taking part in the trial and complete the measurements including the patient-reported outcome measures)

 

[Jonathan Edwards]

Hang on that looks problematic.
It says CRP>5. In other words this treatment will only be given to people with ongoing inflammatory disease. Long Covid doesn't have a raised CRP as far as I know. This is likely to pick out people who have some other problem as well - and treating ill people with a raised CRP without knowing why they have a raised CRP is likely to be dangerous. They might have TB or some other infection.

 

[Nightsong]

Yeah, I was curious about that too. There's a longer list of exclusion criteria on this page:

https://www.isrctn.com/ISRCTN46454974

They're doing IGRA for TB (criterion 14) and excluding patients with "signs of active infection" (11), abnormal liver function (9), neutropenic & thrombocytopenic patients (10), and also excluding HIV, Hep B & C so they'll screen out a lot of other potential causes but, nonetheless, why only include patients with CRP >0.5mg/dL? It won't tell us whether the drug works for a clinically defined "Long COVID" patient population.