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Re: randychub post# 28498

Friday, 10/30/2020 7:33:14 PM

Friday, October 30, 2020 7:33:14 PM

Post# of 44690
Yes... also... Javitt stated they have more data from the open label studies that is showing similar results. So we should expect the 144 results to mimic the ones below, and I would say this is such a very large difference, that we are expecting to blow the required statistical significance out of the water.

Results

• 45 patients enrolled - had the highest possible risk for mortality
...21 were selected for Aviptadil in June & July
...24 were selected for the control group from May - Aug

• 19 of 21 (90%) Aviptadil patients survived to day 28
...4 of 24 (19%) in the control group

• 4 of 5 (80%) Aviptadil patients on ECMO were removed
...3 of 13 (23%) in the control group

• 15 of 16 (94%) Aviptadil patients on vent were removed
...1 of 11 (9%) in the control group

• 10 Aviptadil patients returned home/care facility
...2 in the control group

• 15 of 21 (71%) Aviptadil patients had 100+ point improvement in oxygenation
...4 of 30 (13%) in the control group

Aviptadil Patient Stats

• 9-Fold advantage of survival P<.001
• 9-Fold advantage of recovery from respiratory failure P<.001
• 8 times more likely to return home or a care facility on Aviptadil
• 3-fold improvement in oxygenation
• 17 of 21 saw improvement in both lungs. The other 2 saw improvement in 1 lung
• 2 Patients developed hypotension - treated
• 4 Patients developed diarrhea - treated

Important Note: At ICU admission, the “Rothman index” and “SOFA score” for Aviptadil-treated patients was significantly worse than for control patients. SOFA measures organ failure and Rothman predicts mortality. That means Aviptadil patients were coincidentally already at a huge disadvantage.


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