(Total Views: 677)
Posted On: 06/06/2020 10:36:16 AM
Post# of 153987
Quote:It sure looks to me like they are part of the trial protocol:
I don't think the labs are considered a part of the FDA trial.
Study to Evaluate the Efficacy and Safety of Leronlimab for Mild to Moderate COVID-19
Link: https://clinicaltrials.gov/ct2/show/NCT04343651
Please see excerpt below.
I believe this is why Dr. BP has been so busy and running 3-shifts of 24/7 lab teams. And I'm not sure who would be in a better position to accurately test these metrics, since Dr. BP has an independent lab with a suite of companion assays customized for leronlimab.
The big questions are:
1. Does Dr. NP (or anyone else on the CytoDyn team) have access to up-to-date data on the clinical responses of each patient in each trial?
2. And if so, is there a consistent naming convention used to identify each patient's labs and clinical responses? In other words, is Dr. BP receiving a blood sample that is identified as being from "Patient #12" -- and is Dr. NP able to see the clinical response of "Patient #12"?
Quote:
Other Outcome Measures:
Change in size of lesion area by chest radiograph or CT [ Time Frame: Day 14 ]
Change from baseline in serum cytokine and chemokine levels [ Time Frame: Days 3, 7, and 14 ]
Change from baseline in CCR5 receptor occupancy levels for Tregs and macrophages [ Time Frame: Days 3, 7, and 14 ]
Change from baseline in CD3+, CD4+ and CD8+ T cell count [ Time Frame: Days 3, 7, and 14 ]
(2)
(0)
