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Long Covid drug BC-007 research news
- Thread starter RedFox
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A rare drug trial for long Covid failed, yielding lessons on study design
BC 007, a German infusion that had lifted hope of patients, is heading for new study
A rare drug trial for long Covid failed, yielding lessons on study design
One of the few drug trials for a possible long Covid ended in disappointment. But lessons are leading to a second chance.
www.statnews.com
No suprising that if you just take a lot of different outcomes some can be claimed to be positive just by chance (as seen in the Erlangen study)...A rare drug trial for long Covid failed, yielding lessons on study design
BC 007, a German infusion that had lifted hope of patients, is heading for new study
A rare drug trial for long Covid failed, yielding lessons on study design
One of the few drug trials for a possible long Covid ended in disappointment. But lessons are leading to a second chance.
ME/CFS Science Blog
Senior Member (Voting Rights)
Not really convinced by the arguments in this article.
Reinfections and PEM from travelling to the site would affect both the placebo and treatment arm, so wouldn't explain the lack of difference between them.
Participants were required to have GPCR autoantibodies, similar to the Erlangen study. The article criticises this test, saying patients could try different recruiting sites until the test was positive "which means that the [autoantibodies] are either not always present in the blood, or the test is flawed and can’t always measure them". But this test was the reason to trial BC007 in the first place. The Erlangen study excluded patients with organ damage but it remains to be seen if there were many patients with organ damage in the Berlin cures.
They criticise the outcome measure FACIT Fatigue (which I agree is quite limited) but then happily refer to Erlangens study which used the same FACIT Fatigue scale. The article also claims that "ME researchers have identified surveys and tests that accurately track PEM" which is false. The only questionnaire for PEM is currently the problematic DSQ-PEM and I wouldn't recommend this as a primary outcome measure. There is not a single study that reported a relationship between PEM and 2-day exercise testing.
Then there are some general comments about randomised trials not being adequate, the problematic arguments made by Turner-Stokes on rehabilitation.
Not sure where this is coming from. Randomized controlled trial were not just made for a well-delineated disorder or well-established protocol. If you don't have this, randomized trials are still the way to go, you'll simply need a larger sample size. One can test different protocols and check for dose-response relationships.
hotblack
Senior Member (Voting Rights)
Indeed. I’d be very interested in what sort of trial design they think would be appropriate.
If you don’t think you understand or have a clearly defined treatment group, okay, you need to do a better job there. Just hoping ‘some people get better’ when you give them something but you don’t really understand why or who will or the changes are so small it’s difficult to measure doesn’t sound particularly robust to me.
BrightCandle
Senior Member (Voting Rights)
If BC007 helps some people and not others then they need to go back to pretrial and work out what they think that is. Like the group that found the Natural Killer cell levels impacting on the performance of the drug. I don't doubt some of the mistakes they made are clangers but they aren't why it failed, it failed because it didn't work.