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Posted On: 06/12/2020 1:28:40 PM
Post# of 148870
One of the most interesting (and possibly concerning) relaxed eligibility changes granted by the FDA on June 10 for the P3 S/C trial is the INCLUSION of intubated subjects:
Side-by-Side Comparison
https://clinicaltrials.gov/ct2/history/NCT043...udyPageTop
June 1 Version
June 10 Version
Our first 51 interim subjects were not intubated, so I'm guessing the leronlimab arm maybe had a better chance of avoiding mortality -- not sure of the potential impact to the placebo arm.
Going forward, I assume that may change as we are now allowing patients in greater distress to receive the medication -- but of course, the same holds true for the placebo arm.
Side-by-Side Comparison
https://clinicaltrials.gov/ct2/history/NCT043...udyPageTop
June 1 Version
Quote:
Subject is not intubated (or intubated within 72 hours of the screening). If intubated, positive endexpiratory pressure (PEEP) <15 cmH2O with PaO2/FiO2 >150 mmHg.
June 10 Version
Quote:
Subject, if intubated , positive endexpiratory pressure (PEEP) <15 cmH2O with PaO2/FiO2 >150 mmHg.
Our first 51 interim subjects were not intubated, so I'm guessing the leronlimab arm maybe had a better chance of avoiding mortality -- not sure of the potential impact to the placebo arm.
Going forward, I assume that may change as we are now allowing patients in greater distress to receive the medication -- but of course, the same holds true for the placebo arm.
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