<It is essential, as this is the only thing that proves the treatment is working (or not). >
In Ebola trial there was no placebo, 4 different treatment arm. Background mortality (and other factors) were known, so it was not hard to observe medical benefit, IF any and compare arm.
In COVID19, Kevzara is for SEVERE subjects, where mortality is ~ 10%, and other factor like time to recovery, severity of duration, chronic outcome, is not that hard to calculate from current cases.
Inclusion criteria: Hospitalized with illness of any duration with evidence of pneumonia and severe disease, critical disease, or multi-system organ dysfunction at baseline
Outcome: 6-point Ordinal Scale:
DeathHospitalized, on invasive mechanical ventilation or ECMO;Hospitalized, on non-invasive ventilation or high flow oxygen devices;Hospitalized, requiring supplemental oxygenHospitalized, not requiring supplemental oxygenNot hospitalized
Last two are not important and CONTRADICT inclusion criteria.
So, why OFFER PLACEBO to those who are in need of something to help them recover from infection, WITHOUT ANY POSSIBILITY TO REDUCE CHRONIC DAMAGE!
So, YES, it was extremely stupid.
One Q to you, IF You are one of those subject in hospital, WILL YOU CHOSE TO ENROLL INTO KEVZARA TRIAL, or MAYBE CHOSE SOMETHING ELSE?
Chears!
PS:
clinicaltrials.gov
clinicaltrials.gov
clinicaltrials.gov
Roche is even more stupid than REGN:
clinicaltrials.gov
<Placebo Comparator: Placebo Arm
Participants will receive 1 IV infusion of placebo matched to TCZ. Up to 1 additional dose may be given if clinical symptoms worsen or show no improvement.>
So, even IF YOUR CONDITION WORSEN, YOU are not allowed to have DRUG! GREAT!
And, they claim symptoms improve RAPIDLY!? |
