I have a feeling this is in response to my posts over the last couple of days asking what happened to BP's paper, and where are the "control" group data showing leronlimab is responsible for decreases in plasma viral load and IL-6 in severe Covid subjects:
Of course the control group for the Montefiore EIND cohort is an observational control group with the same panels run as published in Int J Inf Dis yesterday.
In BP's own words from Dr. Drew show on 8/20/20, starting at around 23 minutes in:
https://www.youtube.com/watch?v=3PsSH0Hlas4
Dr. Drew: "Is that the publication that I saw?"
BP: "If the control group is in there, you've seen the revised version. ... The initial one didn't have the control group."
I went and found the above just to convince myself I wasn't going crazy.
First, around 8/11 on Dr. Yo BP said original submission was in final decision stage.
8/20 he says they added the historical cohort of Covid controls who didn't receive leronlimab, with the same panel of IL-6 and presumably plasma viral load. The paper published yesterday (submitted in October) mentions these cohorts in the methods section:
However, I don't see any data at all in the paper published yesterday showing any of these observational control subjects' IL-6, pVL, or CD-8 T-cell counts numbers. Reading the paper again more closely tonight, this is the only reference to the Covid control data in the paper, in the caption for Figure 2:
"Critically ill COVID-19 patients not treated with leronlimab are shown in panel A (right, open symbols, n = 5)."
However, Figure 2 A is the same as the original 5/5/20 paper, and there are no open symbols on the right in the figure, just the healthy controls as black triangles.
So, either they never updated the figure, or both the authors and reviewers and editors at Int J Inf Dis let a lot slip through the cracks.
Sorry to be an "armchair scientist," but it's just odd to me. Not a big deal in the grand scheme of things, but I think having the critical Covid controls cohort (N=5) is important science, to show that the reduction of pVL and IL-6 plus increase of CD8+ T-cells happens only with leronlimab treatment, and not with similar subjects not treated with leronlimab.
Maybe the final version of the paper will fix this apparent error. or maybe I am missing something?
Quote:He wanted me to remind everyone his paper is a "mechanistic study" by no means a clinical trial, there are no such things as a "placebo" group in a mechanistic study. Control "group" is simply a historical group. The study will never try to purport data points for ANY approval process.
Of course the control group for the Montefiore EIND cohort is an observational control group with the same panels run as published in Int J Inf Dis yesterday.
In BP's own words from Dr. Drew show on 8/20/20, starting at around 23 minutes in:
https://www.youtube.com/watch?v=3PsSH0Hlas4
Quote:.. reviewers asking, 'Where are the controls?' ... [discussion about trial design and ethics] We went to our other colleagues who didn't have access to leronlimab. We found control patients. We did the exact same panels of sophisticated assays on that group, and finally came up with a control group that was acceptable and things are moving forward now. We're very excited about that. Yes that was a huge challenge for us, finding a control group, for patients that were beyond the severe coronavirus [cut-off].
Dr. Drew: "Is that the publication that I saw?"
BP: "If the control group is in there, you've seen the revised version. ... The initial one didn't have the control group."
I went and found the above just to convince myself I wasn't going crazy.
First, around 8/11 on Dr. Yo BP said original submission was in final decision stage.
8/20 he says they added the historical cohort of Covid controls who didn't receive leronlimab, with the same panel of IL-6 and presumably plasma viral load. The paper published yesterday (submitted in October) mentions these cohorts in the methods section:
Quote:The five COVID observational control patients are part of a prospective observational cohort of subjects with viral respiratory illness symptoms who presented to Barnes Jewish Hospital, St. Louis Children’s Hospital or affiliated Barnes Jewish Hospital testing sites located in Saint Louis, Missouri, USA. Inclusion criteria required that subjects were symptomatic and had a physician-ordered SARS-CoV-2 test performed in the course of their normal clinical care. All samples were collected at the time of enrollment, which was during or immediately following evaluation in a medical facility. The study was reviewed and approved by the Washington University in Saint Louis Institutional Review Board (WU-350 study approval # 202003085).
However, I don't see any data at all in the paper published yesterday showing any of these observational control subjects' IL-6, pVL, or CD-8 T-cell counts numbers. Reading the paper again more closely tonight, this is the only reference to the Covid control data in the paper, in the caption for Figure 2:
"Critically ill COVID-19 patients not treated with leronlimab are shown in panel A (right, open symbols, n = 5)."
However, Figure 2 A is the same as the original 5/5/20 paper, and there are no open symbols on the right in the figure, just the healthy controls as black triangles.
So, either they never updated the figure, or both the authors and reviewers and editors at Int J Inf Dis let a lot slip through the cracks.
Sorry to be an "armchair scientist," but it's just odd to me. Not a big deal in the grand scheme of things, but I think having the critical Covid controls cohort (N=5) is important science, to show that the reduction of pVL and IL-6 plus increase of CD8+ T-cells happens only with leronlimab treatment, and not with similar subjects not treated with leronlimab.
Maybe the final version of the paper will fix this apparent error. or maybe I am missing something?
6
