With regard to mortality rate, Seth posted the mes
Post# of 154102
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Posted On: 01/12/2021 4:28:07 PM
With regard to mortality rate, Seth posted the message below on YMB. The point is that mortality may be worse than average at the 18 hospitals in this trial because their ICUs are so full. You can see ICU occupancy at the link below at the NY Times (updated yesterday per date at link). I spot-checked 2 of Seth's figures and they were accurate. While this does not offer anything concrete in mortality analysis, perhaps the actual mortality numbers at these hospitals are higher than national averages in spite of SOC improvements. Seth made this statement: "we know that high ICU occupancy significantly increases mortality rates in severe and critical COVID-19 patients". If that is accurate, his point is a good one.
https://www.nytimes.com/interactive/2020/us/c...r-you.html
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With regards to the mortality rate of the control arm of the trial, I think it's vital to look at the study locations we are currently using for CD12. Many of these trial sites have been at or near full ICU capacity since November. The importance of this is critical given that it may explain why the morality rate trend at our 50% interim analysis (45 total deaths) hasn't changed despite the SOC improving and the trial reaching full enrollment months after the interim analysis (at least 87 total deaths, likely ~90 deaths may end up being the final count). This is where our trial sites currently stand: Montefiore Medical Center, Bronx, NY (85% ICU occupancy, 20 beds left), New York Community Hospital of Brooklyn (85% ICU occupancy, 3 beds left), Advanced Cardiovascular LLC, Alexander City, Alabama (No ICU data reported, based in Alexander City, Alabama which has a population of ~14,875 so likely not a large trial site in terms of enrollment. However, Russell Medical Center which is in the same city reported ICU occupancy at 122% with 0 beds left), St. Jude Medical Center, Fullerton, CA (97% ICU occupancy, 2 beds left), UCLA Medical Center, Los Angeles, CA (94% ICU occupancy, 7 beds left), James A Haley Veterans' Hospital, Tampa, FL (No ICU data however, other hospitals in Tampa have between 75-95% ICU occupancy rates), Center for Advanced Research & Education, Gainesville, GA (No ICU data however, the only other hospital in the same town of Gainesville, GA has an ICU occupancy rate of 100% with 0 beds left), Beth Israel Deaconess Medical Center, Boston, MA (91% ICU occupancy, 7 beds left), Novant Health, Winston-Salem, NC (95% ICU occupancy, 6 beds left), Ohio Health Riverside Methodist, Columbus, OH (98% ICU occupancy, 3 beds left), Good Samaritan Hospital Corvallis, Corvallis, OR (74% ICU occupancy, 3 beds left), OHSU, Portland, OR (75% ICU occupancy, 19 beds left), Baylor Scott & White Research Institute, Dallas, TX (100% ICU occupancy, 0 beds left), Baylor College of Medicine, Houston, TX (99% ICU occupancy, 1 bed left), University of Texas, Houston, TX (Couldn't find ICU data but they are located in Houston where our other trial site at that location is at 99% ICU occupancy). What all this data indicates is that our enrollment sites are mostly in the hardest hit areas with respect to ICU space and likely overall cases as well. Furthermore, the sites with the highest ICU occupancy are in areas with the most population such as LA, Dallas, Houston, Columbus, Brooklyn, Winston-Salem, and the Bronx which one would suspect these locations made up the vast majority of CD12 enrollment given that they are in much more densely populated/harder hit areas than our other trial sites. More importantly, this has been the trend in these locations since November and we know high ICU occupancy significantly increases mortality rates in severe and critical COVID-19 patients. It also seems to indicate that there is an extreme abundance of critically ill COVID patients at the vast majority of our trial sites. I believe this bodes extremely well for CD12 trial results and strongly indicates that enrollment since November may be comprised of more critically ill patients than many of us on this board suspected.
https://www.nytimes.com/interactive/2020/us/c...r-you.html
___________________________________________________
With regards to the mortality rate of the control arm of the trial, I think it's vital to look at the study locations we are currently using for CD12. Many of these trial sites have been at or near full ICU capacity since November. The importance of this is critical given that it may explain why the morality rate trend at our 50% interim analysis (45 total deaths) hasn't changed despite the SOC improving and the trial reaching full enrollment months after the interim analysis (at least 87 total deaths, likely ~90 deaths may end up being the final count). This is where our trial sites currently stand: Montefiore Medical Center, Bronx, NY (85% ICU occupancy, 20 beds left), New York Community Hospital of Brooklyn (85% ICU occupancy, 3 beds left), Advanced Cardiovascular LLC, Alexander City, Alabama (No ICU data reported, based in Alexander City, Alabama which has a population of ~14,875 so likely not a large trial site in terms of enrollment. However, Russell Medical Center which is in the same city reported ICU occupancy at 122% with 0 beds left), St. Jude Medical Center, Fullerton, CA (97% ICU occupancy, 2 beds left), UCLA Medical Center, Los Angeles, CA (94% ICU occupancy, 7 beds left), James A Haley Veterans' Hospital, Tampa, FL (No ICU data however, other hospitals in Tampa have between 75-95% ICU occupancy rates), Center for Advanced Research & Education, Gainesville, GA (No ICU data however, the only other hospital in the same town of Gainesville, GA has an ICU occupancy rate of 100% with 0 beds left), Beth Israel Deaconess Medical Center, Boston, MA (91% ICU occupancy, 7 beds left), Novant Health, Winston-Salem, NC (95% ICU occupancy, 6 beds left), Ohio Health Riverside Methodist, Columbus, OH (98% ICU occupancy, 3 beds left), Good Samaritan Hospital Corvallis, Corvallis, OR (74% ICU occupancy, 3 beds left), OHSU, Portland, OR (75% ICU occupancy, 19 beds left), Baylor Scott & White Research Institute, Dallas, TX (100% ICU occupancy, 0 beds left), Baylor College of Medicine, Houston, TX (99% ICU occupancy, 1 bed left), University of Texas, Houston, TX (Couldn't find ICU data but they are located in Houston where our other trial site at that location is at 99% ICU occupancy). What all this data indicates is that our enrollment sites are mostly in the hardest hit areas with respect to ICU space and likely overall cases as well. Furthermore, the sites with the highest ICU occupancy are in areas with the most population such as LA, Dallas, Houston, Columbus, Brooklyn, Winston-Salem, and the Bronx which one would suspect these locations made up the vast majority of CD12 enrollment given that they are in much more densely populated/harder hit areas than our other trial sites. More importantly, this has been the trend in these locations since November and we know high ICU occupancy significantly increases mortality rates in severe and critical COVID-19 patients. It also seems to indicate that there is an extreme abundance of critically ill COVID patients at the vast majority of our trial sites. I believe this bodes extremely well for CD12 trial results and strongly indicates that enrollment since November may be comprised of more critically ill patients than many of us on this board suspected.
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