Check out the addendum from 10/19 at the end of this post. COVID IS SOOOOO FRUSTRATING TO TREAT! Another tool taken out of the tool box with this COVACTA study looking at tocilizumab in COVID-19. Several weeks ago, I covered tocilizumab and cytokine storm in this post. Check it out for further details. I am quite familiar with tocilizumab as we are administering it to patients who are in the potentially aberrantly named “cytokine storm”. These days, we have been provided with press releases touting positive results from trials prior to actual publications. Note that this is an industry sponsored trial.
Primary Endpoint: Clinical Status
This practice of press releases is troubling to some including myself, especially when the actual studies show less than stellar outcomes (a’hem Remdesivir). This case is different, however. Unfortunately, tocilizumab “did not meet its primary endpoint of improved clinical status in hospitalized adult patients with severe COVID-19 associated pneumonia”. Poop. I could’ve sworn this was working in my patients if provided at the right time.
Secondary Endpoint: Mortality, Vent days regarding tocilizumab (COVACTA)
If the primary endpoint of clinical status didn’t get better, you can certainly count on the fact that it did not change mortality on these patients. This is also the case. By week 4, 19.7% of patients in the tocilizumab group died and 19.4% in the control group died.
Patients did not get off the vent faster, either. 22 vent-free days in the tocilizumab arm and 16.5 days in the placebo group. I know you’re asking yourself, well that’s a difference! But ultimately it wasn’t statistically significant. Sigh.
Infection rates were the same in both groups. There was a study out of Michigan that showed improved mortality but a greatly increased risk of secondary infections. This was not seen here. 21.0% in the tocilizumab arm and 25.9% in the control arm. It’s shocking to me how many of these patients developed secondary infections in the control arm.
Patients did get discharged faster from the hospital, though. 20 days versus 28 days. The very honest authors state that “the difference cannot be considered statistically significant as the primary endpoint was not met”.
What next?
There are still many things we don’t know about the trial, but if they pharmaceutical company poised to profit throws in the towel, it’s sufficient justification to do so. Another tool out of the toolbox. It’s a shame. I could have sworn that it helped certain individuals. Perhaps the timing was off? I don’t know. Currently struggling with so few treatments to provide to our patients. I am not a betting man but I would have bet that this would have potentially been a game changer. So much for Tocilizumab in the COVACTA trial.
Link to Press Release
Link to Press Release PDF
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ADDENDUM: BUT WAIT, THERE’S MORE! Is Tocilizumab not quite yet dead in the water?
This editorial published in the Lancet-Rheumatology several months ago explores what may have gone wrong with Tocilizumab in the trial and begs us to wait for the tocilizumab arm of the RECOVERY trial to be published which will have more patients enrolled.
Furlow B. COVACTA trial raises questions about tocilizumab’s benefit in COVID-19. Lancet Rheumatol. 2020 Oct;2(10):e592. doi: 10.1016/S2665-9913(20)30313-1. Epub 2020 Sep 9. PMID: 32929415; PMCID: PMC7480990.
Link to Article
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