Clinical trial “Methylprednisolone in Patients With Cognitive Deficits in Post-COVID-19 Syndrome (PCS)”

[kushami]

I didn’t see this one posted yet.

Clinical trial in Germany:

This clinical trial aims to learn about the therapeutic value of methylprednisolone, a well-known immunosuppressant, on cognitive deficits in patients with post-COVID-19 syndrome (PCS).

The main questions it aims to answer are:
1) Does methylprednisolone improve memory function in PCS patients compared to placebo?
2) Does methylprednisolone improve other patient centered outcomes in PCS patients such as fatigue, mood and quality of life compared to placebo?
3) What are the side effects of methylprednisolone in this patient population, and how common are they?

Participants in this study will be patients with PCS and cognitive deficits, who will be asked to participate for 52 weeks. They will be randomly assigned to one of two groups: One group will receive methylprednisolone once daily for six weeks, with a dosage reduction after week 4. The other group will receive a matching placebo once daily for six weeks, following the same titration regimen to ensure blinding. Participants will attend outpatient follow-up visits in weeks 8 and 20, with a final telephone follow-up after 52 weeks. Clinical examinations and safety monitoring will be conducted during the treatment phase.

This study's results may help develop more effective therapies for this condition.

I was surprised to see this one, as doctors are usually so loath to prescribe steroids beyond a very short course without quite some justification.

In fact I have asked my rheumatologist to do a burst like this for me, as we know my symptoms resolved completely on a five-day course that I happened to take for a rash a while ago. And I had a three-month remission after the five days. But he said no.

If this study is successful and there aren’t too many side effects reported, I will try to get him to change his mind.

 

[kushami]

Forgot to mention that Dr Carmen Scheibenbogen is working on this. List of people involved is here:

https://pubmed.ncbi.nlm.nih.gov/38509608/

 

[kushami]

And here is a link to the study on the organisation’s website that explains the protocol a bit better:
https://cfc.charite.de/en/clinical_research/nksg/trial_pocovit/

Participants will be randomized to receive a moderate oral dose of methylprednisolone (~1mg/kg body weight) or placebo for 4 weeks, followed by tapering off over 2 weeks. Two weeks after the completion of the study medication, the effect on cognitive functions will be measured using a specific scale for subjective satisfaction with memory functions.

To provide an active treatment to patients who received the placebo during the first study phase and to potentially evaluate additive effects through a second treatment interval, all patients will receive a methylprednisolone therapy with the same dosage in a second study phase—final outcome assessment again taking place 2 weeks after the end of treatment.

 

[heapsreal]

I didn’t see this one posted yet.









I was surprised to see this one, as doctors are usually so loth to prescribe steroids beyond a very short course without quite some justification.

In fact I have asked my rheumatologist to do a burst like this for me, as we know my symptoms resolved completely on a five-day course that I happened to take for a rash a while ago. And I had a three-month remission after the five days. But he said no.

If this study is successful and there aren’t too many side effects reported, I will try to get him to change his mind.

What was the dose they were on? If it's a physiological dose ie keeping cortisol within the normal range, there can be less chances of any side effects.

Recently watched a video on different blood test markers showing up on LC, and low cortisol was one of them. So a replacement dose might be working by treating their low cortisol levels??

 

[kushami]

What was the dose they were on? If it's a physiological dose ie keeping cortisol within the normal range, there can be less chances of any side effects.

Recently watched a video on different blood test markers showing up on LC, and low cortisol was one of them. So a replacement dose might be working by treating their low cortisol levels??

The dosing schedule is descibed in the quote in my third post above.

There is no mention in the study design of checking the participants’ cortisol levels. However, the study design does say:

”Exploratory outcomes involve molecular biomarkers variations in serum and cerebrospinal fluid, as well as structural and functional brain magnetic resonance imaging (MRI) parameters changes related to cognition.”

The biomarkers seem to be autoimmune related:

”Our data indicates that off-label administration of methylprednisolone resulted in subjective improvements and enhanced performance on neuropsychological tests in a high proportion of PCS patients with CSF autoantibodies (data in preparation).“

So it is an immune-suppression approach, not a replacement one. Will be interesting to see the data they refer to.

 

[kushami]

Also, replacement doses would continue indefinitely, no? The medication is only given for six weeks, with the rest of the year consisting of follow-up, presumably to see whether study participants can be said to have had lasting remission or not at the one-year mark.

And, I forgot to say: 400 participants! Nice big cohort!

 

[kushami]

Reading this again, the dose seems rather high. For instance, if I were in the study, I would be taking 80mg of methylprednisone a day for six weeks. And they call this a moderate dose.

Am I missing something?