Looked back at PR Aug 25 for Severe/Critical phase
Post# of 153822
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Posted On: 09/22/2020 4:34:07 PM
Looked back at PR Aug 25 for Severe/Critical phase 3, CD12.
Reached enrollment required for interim analysis. I was wondering though I know it’s been discussed here what date the interim analysis might occur. Could start Friday or Monday, I guess, but I was struck by an ‘secondary outcome’ today that didn’t smack me in the face a month ago.
“and (4) change from baseline in Sequential Organ Failure Assessment (SOFA) score at Day 14.”
I bet we crush this one compared to ‘baseline’ based on reduction in coagulopathies (sp?) alone, I’m thinking kidneys, brain, pulmonary generally. In my own layman’s terms.
The quote below from Aug 25th PR. I was also reminded that (compared to various HIV dosages) CD12 was straight to 700mg. I like that number.
“This Phase 3 trial is a two-arm, randomized, double blind, placebo controlled, adaptive design multicenter study to evaluate the safety and efficacy of leronlimab in patients with severe-to-critical symptoms of respiratory illness caused by COVID-19. Patients are randomized to receive weekly doses of 700 mg leronlimab or placebo, administered via weekly subcutaneous injection for two weeks. The study has three phases lasting 28 days: Screening Period, Treatment Period, and Follow-Up Period. The primary outcome measured in this study is: all-cause mortality at Day 28. Secondary outcomes measured are: (1) all-cause mortality at Day 14, (2) change in clinical status of subject at Day 14, (3) change in clinical status of subject at Day 28, and (4) change from baseline in Sequential Organ Failure Assessment (SOFA) score at Day 14. Recently, the Data Safety Monitoring Committee (“DSMC”) completed its first safety review of patients in the Phase 3 trial and reported it saw no cause to modify the study. The DSMC reviewed safety data from 149 of the 169 patients enrolled at the time of their review. The DSMC did not raise any concerns regarding safety and recommended the trial continue as planned.”
Reached enrollment required for interim analysis. I was wondering though I know it’s been discussed here what date the interim analysis might occur. Could start Friday or Monday, I guess, but I was struck by an ‘secondary outcome’ today that didn’t smack me in the face a month ago.
“and (4) change from baseline in Sequential Organ Failure Assessment (SOFA) score at Day 14.”
I bet we crush this one compared to ‘baseline’ based on reduction in coagulopathies (sp?) alone, I’m thinking kidneys, brain, pulmonary generally. In my own layman’s terms.
The quote below from Aug 25th PR. I was also reminded that (compared to various HIV dosages) CD12 was straight to 700mg. I like that number.
“This Phase 3 trial is a two-arm, randomized, double blind, placebo controlled, adaptive design multicenter study to evaluate the safety and efficacy of leronlimab in patients with severe-to-critical symptoms of respiratory illness caused by COVID-19. Patients are randomized to receive weekly doses of 700 mg leronlimab or placebo, administered via weekly subcutaneous injection for two weeks. The study has three phases lasting 28 days: Screening Period, Treatment Period, and Follow-Up Period. The primary outcome measured in this study is: all-cause mortality at Day 28. Secondary outcomes measured are: (1) all-cause mortality at Day 14, (2) change in clinical status of subject at Day 14, (3) change in clinical status of subject at Day 28, and (4) change from baseline in Sequential Organ Failure Assessment (SOFA) score at Day 14. Recently, the Data Safety Monitoring Committee (“DSMC”) completed its first safety review of patients in the Phase 3 trial and reported it saw no cause to modify the study. The DSMC reviewed safety data from 149 of the 169 patients enrolled at the time of their review. The DSMC did not raise any concerns regarding safety and recommended the trial continue as planned.”
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