Safety, tolerability and clinical effects of... BC007 on fatigue and quality of life in patients with Post-COVID syndrome, 2025, Hohberger+

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EndME

Senior Member (Voting Rights)

Safety, tolerability and clinical effects of rovunaptabin, also known as BC007 on fatigue and quality of life in patients with Post-COVID syndrome (reCOVer): a prospective, exploratory, placebo-controlled, double-blind, randomised phase IIa clinical trial (RCT)​


Background​

Rovunaptabin neutralises functional autoantibodies targeting G-Protein coupled receptors (GPCR-fAAbs), observed in patients with Post-COVID syndrome. As we hypothesise an improvement of PCS by rovunaptabin, the aim of reCOVer was to investigate safety, tolerability, and clinical effects of rovunaptabin in PCS patients.

Methods​

reCOVer is a prospective, exploratory, placebo-controlled, double-blind, randomised phase IIa clinical investigator initiated trial with 1350 mg rovunaptabin with additional cross-over at the Universitätsklinikum Erlangen, Germany. The trial was registered in EudraCT, 2022-001781-35. Screening was done between 21·11·2023 and 25·06·2024. Eligible participants (18–80 years) showed GPCR-fAAbs, at least 3/8 defined PCS symptoms persisting ≥3 months after COVID-19 and fatigue as major symptom. Participants were randomly assigned (1:1) to either receive rovunaptabin or placebo at day 0 (d0) and d48 with a follow-up of 28 days, respectively. Primary endpoint was the number of treatment emergent adverse events (TEAE) at d28 (co-primary endpoint: TEAE at d70); secondary endpoint focused on fatigue and quality of life.

Findings​

Thirty PCS patients were randomised and analysed. RCT analysis showed nine (rovunaptabin) and five TEAEs (placebo), yet without statistically significance (p = 0·1299; CI −14·80%; 63·02%); one serious adverse event, not related to treatment, was recorded. Rovunaptabin showed a neutralisation of GPCR-fAAb and a significant improvement of FACIT Fatigue Scale (effect size = 2·10, p = 0·0378), Bell score (effect size = 3·64, p = 0·0004), Fatigue Severity Scale (effect size = −2·66, p = 0·0088), and quality of life (4/8 items).

Interpretation​

As this proof-of-concept study showed effects on the patient-centred endpoint PCS and a good safety profil, subsequent studies are needed to confirm these results in a larger cohort.

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FACIT is 0 to 52, bell is 0 to 100, these effect sizes are tiny and well within the normal variance of the disease and I suspect quite likely below the usual threshold for a detectable change from the questionaries themselves. I saw the same thing being done on some studies with Chalder fatigue studies as well where they hoped we didn't know what the threshold of the questionaires was, they were P hacking to find significance and that was how they did it, this looks to be the case here as well.

The other much larger BC007 study failed. I see no reason to think another BC007 will succeed, they are depleting the GCPR antibodies and its not helping.
 
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The improvement of fatigue was apparent by the FACIT fatigue scale, Bell scale, FSS, and CCC, yet not by the Chalder fatigue scale, DSQ-PEM, and Borg scales. This data demonstrates clear differences between the different fatigue questionnaires. In addition, patients did not show a significant increase of their walking distance, as measured by the 6MWT.
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So they got some minor improvement on some of the scales, but nothing in the only objective outcome measure related to functioning.
 
Utsikt said:
View attachment 27263

So they got some minor improvement on some of the scales, but nothing in the only objective outcome measure related to functioning.
Click to expand...
None of these graphs look impressive and are surely all clinically irrelevant, despite the section bias of only showing those things that even had a positive result.

Berlin Cures has to be the happiest pharmaceutical company of all time. Not a dime invested into drug development, patients are happy to finance your studies and patients and researchers will do all the marketing for you despite trials not showing anything meaningful.
 
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